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MINISTRY OF HEALTH MALAYSIA
Malaysian National Medicines Policy2nd Edition, 2012
MASTER PLANOF ACTION
MASTER PLANOF ACTION
Malaysian National Medicines Policy2nd Edition, 2012
MINISTRY OF HEALTH MALAYSIA
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012II
First print 2014
Copyright © 2014 byPharmaceutical Services Division
Ministry of Health MalaysiaLot 36, Jalan Universiti, 43650 Petaling Jaya, Selangor
All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, without the prior permission in writing.
The only exception is by a reviewer, who may quote short excerpts in a review.
ISBN 978-967-5570-51-3
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012 III
ACKNOWLEDGEMENTS .........................................................................................................vi
EDITORIAL COMMITEE .........................................................................................................vii
MALAYSIAN NATIONAL MEDICINES POLICY (MNMP) Introduction ............................................................................................................................... 1
1. GOVERNANCE IN MEDICINES .......................................................................................... 3
AIM ...................................................................................................................................4
STRATEGY ......................................................................................................................4
Strategy 1 : Code of Conduct ..................................................................................4
Strategy 2 : Legislation and Regulations ...............................................................4
2. QUALITY, SAFETY AND EFFICACY OF MEDICINES......................................................... 5
AIM ...................................................................................................................................6
STRATEGY ......................................................................................................................6
LEGISLATION AND REGULATIONS ..............................................................................7
Strategy 1: National Pharmaceutical Control Bureau (NPCB) .............................. 7
Strategy 2: Regulating Premises that Supply Medicines ....................................8
Strategy 3: Effective Enforcement .........................................................................9
Strategy 4: Medicines Advertisement and Promotion .........................................10
Strategy 5: Counterfeit Medicines .........................................................................10
PHARMACEUTICAL QUALITY ASSURANCE ............................................................... 11
Strategy 1: Post-Marketing Surveillance ............................................................ 11
Strategy 2: Management of Complaints about Medicines ................................ 11
3. ACCESS TO MEDICINES .................................................................................................. 13
AIM .................................................................................................................................14
STRATEGY ....................................................................................................................14
AVAILABILITY OF MEDICINES .....................................................................................16
A) SELECTION OF MEDICINES ...................................................................................16
Strategy 1: National Medicines Formulary ..........................................................16
Strategy 2: National Essential Medicines List (NEML) ......................................17
Strategy 3: Drug and Therapeutic Committee .....................................................17
CONTENTS
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012Iv
Strategy 4: Traditional and Complementary Medicines Formulary ................... 18
Strategy 5: Life-saving Medicines and Orphan Medicines ................................18
Strategy 6: Halal Medicines ..................................................................................19
B) SUPPLY OF MEDICINES ..........................................................................................20
Strategy 1: Procurement ........................................................................................20
Strategy 2: Distribution and Storage of Medicines ...........................................21
Strategy 3: Disposal of Medicines ........................................................................21
Strategy 4: Medicines Supply in Emergency Situations and Medicines Dona-tions .........................................................................................................................22
AFFORDABILITY OF MEDICINES ................................................................................22
A) NATIONAL PRICING REFERENCE FOR MEDICINES ..........................................22
Strategy 1: Transparency on Price Information ...................................................22
Strategy 2: Monitoring of Price Information .........................................................23
Strategy 3: Tariffs and Duties ...............................................................................23
B) FINANCING FOR MEDICINES .................................................................................24
C) GENERIC MEDICINES POLICY ...............................................................................24
Strategy 1: Prescribing in generic International Non-proprietary Name (INN) 24
Strategy 2: Procurement of all medicines by generic INN .................................25
Strategy 3: Selection for procurement in generic INN ........................................25
Strategy 4: Generic Labelling Practice .................................................................25
Strategy 5: Interchangeable and Non-interchangeable Medicines ................... 25
Strategy 6: Generic Medicine Substitution For All Interchangeable Medicines 26
Strategy 7: Appropriate incentives to promote the use of generic medicines and their production in the country .................................................26
4. QUALITY USE OF MEDICINES ......................................................................................... 27
AIM .................................................................................................................................28
STRATEGY ...................................................................................................................28
DEVELOPMENT AND IMPLEMENTATION OF MODELS OF BEST PRACTICE ......... 29
EDUCATION AND TRAINING ........................................................................................30
Strategy 1: Healthcare Providers ..........................................................................30
Strategy 2: Consumers ..........................................................................................31
Strategy 3: Pharmaceutical Industry ..................................................................31
Strategy 4: Media ...................................................................................................32
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012 v
PROVISION OF TIMELY AND ACCURATE INFORMATION ON MEDICINES ............. 32
Strategy 1: Healthcare Providers .........................................................................32
Strategy 2: Consumers ..........................................................................................32
Strategy 3: Pharmaceutical Industry ....................................................................32
Strategy 4: Media ...................................................................................................33
STRENGTHENING SEAMLESS CARE BETWEEN HEALTHCARE PROVIDERS ....... 33
RESEARCH AND DEVELOPMENT IN QUALITY USE OF MEDICINES ....................... 33
5. PARTNERSHIP AND COLLABORATION FOR THE HEALTHCARE INDUSTRY .......................... 35
AIM .................................................................................................................................36
STRATEGY ....................................................................................................................36
HUMAN RESOURCE DEVELOPMENT .........................................................................37
RESEARCH AND DEVELOPMENT ...............................................................................37
TECHNICAL COLLABORATION AND PARTNERSHIP .................................................38
A VIABLE AND RESPONSIBLE PHARMACEUTICAL INDUSTRY ...............................38
Strategy 1: Domestic Pharmaceutical Manufacturing ........................................38
LIST OF ORGANISING COMMITTEE MEMBERS ................................................................ 39
PANEL DISCUSSION MEMBERS.......................................................................................... 40
LIST OF PARTICIPANTS ....................................................................................................... 41
ABBREVIATIONS .................................................................................................................. 46
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012vI
ACKNOWLEDGEMENTS
The Pharmaceutical Services Division (PSD) of the Ministry of Health would like to thank the following participants and stakeholders for their support and contribution in the preparation of this master plan of
action for Malaysian National Medicines Policy 2nd Edition (2012):
Pharmaceutical Services Division, State Health DepartmentsNational Pharmaceutical Control Bureau
Medical Development Division, Ministry of HealthHuman Resource Division, Ministry of Health
Policy and International Relations Division, Ministry of HealthProcurement and Privatisation Division, Ministry of Health
Traditional and Complementary Medicine Division, Ministry of HealthTraining Management Unit, Ministry of Health
Educational Policy Planning and Research Division, Ministry of EducationHealth Services Division of the Malaysian Armed Forces HQ, Ministry of Defence
Forest Research Institute Malaysia (FRIM)Malaysia Biotechnology Corporation Sdn. Bhd.
Malaysia Department of Islamic Development (JAKIM)Malaysian Investment Development Authority (MIDA)
International Islamic University Malaysia (IIUM)University of Malaya (UM)
University Technology MARA (UiTM) Universiti Kebangsaan Malaysia Medical Centre (UKMMC)
University Malaya Medical Centre (UMMC)Malaysian Medical Association (MMA)
Malaysian Pharmaceutical Society (MPS)Malaysian Academy of Pharmacy
Association of Private Hospitals Malaysia (APHM)Consumer Association of Penang (CAP)
Direct Selling Association of Malaysia (DSAM)Federation of Private Medical Practitioners’ Associations Malaysia (FPMPAM)
Malaysian Organisation of Pharmaceutical Industries (MOPI)Malaysian Association of Pharmaceutical Suppliers (MAPS)
MERCY MalaysiaPharmaceutical Association of Malaysia (PhAMA)
Pharmacists and medical doctors from public and private hospitals.
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012 vII
EDITORIAL COMMITEE
ADVISORDr. Nour Hanah binti Othman
EDITORIAL COMMITEEMs. Hasnizan binti Hasan
Ms. Bibi Faridha binti Mohd SallehMs. Lau Ling Wei
Ms. Melanie binti HassimMs. Phuar Hsiao Ling
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012 1
MALAYSIAN NATIONAL MEDICINES POLICY (MNMP)
INTRODUCTIONIn September 2013, a workshop involving relevant stakeholders from the government agencies and private institutions was conducted towards preparation of Master Plan of Action for second term of MNMP. The efforts from this workshop yielded this revised edition of MNMP Master Plan of Action.
The objective of the Malaysian National Medicines Policy is to promote equitable access and rational use of safe, effective and affordable essential medicines of good quality to improve health outcomes of the people.
The policy implementation from the first term has shown tremendous positive outcomes and transformation. Achievements in establishing a comprehensive regulation system, strengthening of the laws and regulations, creating a robust pharmaceutical industry as well as developing an extensive pharmaceutical distribution network were observed. Nevertheless, improvement can still be adopted in several areas through reinforcement and embracing new ideas abiding to the policy objective.
With the revision of the MNMP, new policy statements and strategies are introduced for the pharmaceutical and health sectors to move forward and to provide for the present needs of the nation, as well as to improve and support existing government policies in line with current global developments. Four core components and four supporting components of the original policy had been reorganized. These resulted in five components as followed:
i. Governance in Medicines
ii. Quality, Safety and Efficacy of Medicines
iii. Access to Medicines
iv. Quality Use of Medicines
v. Partnership and Collaboration for the Healthcare Industry
Alongside the formation of the revised edition of MNMP, an appropriate and practical Plan of Action was developed based on the newly-organized components and the strategies outlined in the policy. With the reconciliation of efforts from all the stakeholders, it is very much anticipated that the implementation of the Plan of Action will bring a remarkable impact to the health of the nation.
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 20122
1. GOVERNANCE IN MEDICINES
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 20124
1. GOVERNANCE IN MEDICINES
POLICYGood governance, practices, conduct and professionalism shall be emphasised within the healthcare industry towards achieving optimal health outcomes.
AIM
• To have appropriate governance that ensures the provision of safe, effective and affordable medicines within the best practice environment.
• To ensure all stakeholders are responsible for conducting themselves in an ethical and professional manner.
• To ensure regulations facilitate and support the provision of safe, effective and affordable medicines.
STRATEGY
Strategy 1 : Code of Conduct
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Establish committee to review current code of conduct (CoC)
2014 Formation of CoC Review committee
2014 DUNas Secretariat
2. Identify and review current CoC for all healthcare stakeholders
2015 Number of CoC reviewed
All stakeholders
DUNas Secretariat/Relevant stakeholders
3. Identify gaps within the existing CoC
2015 Set criteria/ framework for CoC review
Yes DUNas Secretariat/ Relevant stakeholders
Strategy 2 : Legislation and Regulations
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Development and strengthening the existing directives and guidelines under the proposed Pharmacy Act
2013-2016 Number of directives and guidelines developed
Upon effective date of new Pharmacy Act
Enforcement Pharmacy / Relevant Stakeholders
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012
2. QUALITY, SAFETY AND EFFICACY OF MEDICINES
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 20126
2. QUALITY, SAFETY AND EFFICACY OF MEDICINES
POLICYOnly safe, efficacious and quality medicines that meet approved standards and specifications shall be registered and made available for sale and use by all consumers in Malaysia.
AIM
• To ensure that medicines marketed for consumers are safe, effective and of quality, and to promote quality use of medicines to meet the health needs of the nation.
STRATEGYThe aim shall be achieved by strengthening the medicines regulatory system through a comprehensive medicines legislation framework, enhanced measures for pharmaceutical quality assurance and effective post-marketing surveillance with positive cooperation and collaboration between the regulators and the relevant stakeholders.
LEGISLATION AND REGULATIONS
Strategy 1 : National Pharmaceutical Control Bureau (NPCB)
Strategy 2 : Regulating Premises that Supply Medicines
Strategy 3 : Effective Enforcement
Strategy 4 : Medicines Advertisement and Promotion
Strategy 5 : Counterfeit Medicines
PHARMACEUTICAL QUALITY ASSURANCE
Strategy 1 : Management of Complaints about Medicines
Strategy 2 : Post-Marketing Surveillance
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012 7
LEGISLATION AND REGULATIONS
Strategy 1: National Pharmaceutical Control Bureau (NPCB)
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. In support of the transformation in the Malaysian healthcare programme, the NPCB is to be restructured as an autonomous body:
Pharmaceutical Services
Division (PSD) & NPCBa) Preparation of proposal
for new structure and function of NPCB for MOH policy decision
2014 Is the proposal for new structure and function of NPCB ready?
Yes(by early
2015)
b) Application for financial allocation under Dasar Baru 2015 for consultancy services in drafting the bill for NPCB to become an autonomous body
2014 Is the financial allocation under Dasar Baru 2015 applied?
Yes(by end of
2015)
c) To conduct Regulation Impact Assessment
2015 Regulation Impact Assessment done
Yes(by 2015)
d) To prepare for the bill to Attorney General
2015 Bill prepared to Attorney General (AG)
Yes(by 2015)
2. Ensuring/enhancing all regulatory requirements meet/ at par with international standards:
NPCB
a) MoU participation 2015 Technical bilateral with other Regulatory Agency
100%
b) Joint inspection and assessment
i) 2016(subject to PIC/S schedule/ invitation)
Participation in Joint inspection with PIC/S team
Yes
ii) On-going Participation in Joint assessment with PIC/S team
Yes
iii) Q4 2017 Participation in joint assessment with OECD GLP team
Yes
c) To be *fully functional National Drug Regulatory Agency (NDRA) in Biologics and Vaccines
Q1 2017 i) Fully functional NDRA in Vaccines
Yes
ii) Fully functional NDRA in Biologics
Yes
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 20128
No. Activities Implementation Timeline Indicators Targets Stakeholder
3. Drafting and preparing guideline for cell and gene therapy
Q4 2014 Establishment and implementation of the guideline
Yes(by Q4 2014)
NPCB
4. a) Establishing (drafting and preparing) guideline on efficacy claims for herbal products
2015 Establish and implement guideline
Yes(by Q4 2014)
NPCB
b) Evaluating efficacy claims for herbal products
2015 List of application received and evaluated
Yes NPCB
5. Requirement for non-clinical studies for new products registered under NCE and biotechnology to comply with OECD GLP principles
2015 Percentage of NCE and biotechnology products with non-clinical studies complying to OECD GLP principles
100% NPCB, Industrial
Stakeholders
6. Regulation of API manufacturers exporting to EU
Starting July 2013
Percentage of written confirmation (GMP certificate) being accepted by EU
100% NPCB
*Fully functional = NDRA who has passed the WHO assessment for a list of 6 functions as below: i. Function 1: Marketing Authorisation and Licensing Activitiesii. Function 2: Pharmacovigilance Activities including surveillance of Adverse Events Following Immunization (AEFI)iii. Function 3: NRA Lot Releaseiv. Function 4: Laboratory Accessv. Function 5: Regulatory inspectionsvi. Function 6: Regulatory oversight on clinical trials
Strategy 2: Regulating Premises that Supply Medicines
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. To authorise all retailers dealing with registered products and cosmetics
Upon effective date of new
Pharmacy Act
Percentage of authorised retail premises committing offence
TBD Local Authorities,
PSD
2. Inspection on retail premises dealing with medicinal product
On-going Percentage of retail premises in compliance with Pharmacy Legislation
80% PSD
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012 9
Strategy 3: Effective Enforcement
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Inspection of sterile preparation facilities (Cytotoxic Drug Reconstitution and Total Parenteral Nutrition) in healthcare establishment
2017 Percentage of sterile preparation facilities of private and government healthcare establishment inspected
More than 80%
NPCB
2. To ensure all importers of vaccines and blood products comply with cold chain requirement during products distribution (to the extent of importers)
2014 – 2015 Percentage of batches of vaccines and blood products that comply with cold chain requirement
100% NPCB
3. To ensure that all imported products* marketed in Malaysia: NPCB
a) Manufactured by a manufacturer that has been inspected by any PIC/S Participating Authorities or PIC/S partners
2017 Percentage of imported products manufactured by a manufacturer that has been inspected by PIC/S Participating Authority or PIC/S partners through acceptance of GMP certificate
100%
b) GMP facilities inspected by NPCB
2017 Percentage of Foreign GMP Inspections conducted
100% NPCB
c) BE conducted in accredited BE centres (for imported product that requires BE)
2017 Percentage of imported product with BE from an accredited BE centre
100% NPCB
*Excluding Traditional products, Health Supplements and Veterinary products
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 201210
Strategy 4: Medicines Advertisement and Promotion
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Regulate all advertisement and promotion of drugs (including health supplements and traditional medicines) through:
PSD, Media Associations
a) Media screening (PSD) On-going Percentage of advertisements in violation of regulations on the ethical promotion of drugs
Not more than 10%
b) Pre-approval (PSD) 2016 – 2017 (abolished upon New Pharmacy
Act)
c) Self-regulation (Industry)
2016 – 2017(upon effective
date of New Pharmacy Act)
Percentage of action taken for advertisements in violation of regulations
100%
Strategy 5: Counterfeit Medicines
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Monitoring of retailers and wholesaler through inspection
2016 – 2017(upon effective
date of New Pharmacy Act)
Percentage of counterfeit medicines seized
TBD (to get
baseline data)
Local Authorities,
PSD
2. Public Awareness and roadshow on counterfeit/ SSFFC issues
On-going Number of activities conducted
Not less than 50 per year
PSD
3. Comprehensive monitoring of illegal online sale of medicine by Pharmacy Digital Forensic Unit
2015
Percentage of websites selling medicine illegally for which action is taken
Not less than 50%
TBD (to get
baseline data)
PSD, MCMC
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012 11
PHARMACEUTICAL QUALITY ASSURANCE
Strategy 1: Post-Marketing Surveillance
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. To ensure quality of vaccines imported by reviewing lot summary protocol of imported vaccines
2014(concurrent
with ‘Effective Enforcement’
activity: cold chain
requirement)
i) Percentage of lot summary protocol reviewed
100% NPCB
ii) Percentage of lot release certificate released
TBD(to get
baseline data)
NPCB and Industrial
Stakeholders
2. Adverse event following immunization (AEFI) monitoring programme
On-going Percentage of investigation of serious AEFI
100% NPCB
3. Sampling of registered products
Starting Jan 2013 i) Percentage of products within the registration period being sampled
100% NPCB
ii) Percentage of products sampled
50%
4. Action taken over products found non-conforming to its quality specification
On-going Percentage of *regulatory action taken over non-conforming products
100% NPCB
5. Enhancement of training on ADR reporting for Healthcare Professional to improve quality of ADR reports
On-going WHO Report #Completeness Score (0 – 1)
2013: 0.52014-2015:
target 0.62015-2017:
target > 0.7
NPCB
*Action taken by regulator such as warning, product recall, suspension or cancellation of product registration#Completeness score = a measure of the amount of information on Individual Case Safety Reports as appear in VigiBase (0 = Poor quality ICSR, 1 = Good quality ICSR)
Strategy 2: Management of Complaints about Medicines
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Investigation of complaints on registered products
On-going Percentage of complaints investigated and resolved within 30 days
Not less than 85%
NPCB
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012
3. ACCESS TO MEDICINES
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 201214
3. ACCESS TO MEDICINES
POLICY An efficient and integrated medicines management and supply network shall be maintained. The pharmaceutical industry shall be organised and regulated to create incentives and foster competition in medicine prices. Appropriate financing mechanisms shall be developed to ensure essential medicines needed for quality healthcare are affordable.
AIM
• To ensure adequate, continuous and equitable access to quality, safe, effective and affordable medicines towards achieving optimal health outcomes.
STRATEGYThe aim shall be achieved by ensuring the availability and affordability of medicines through:
• A fair and transparent medicines selection mechanism in accordance with the country’s health needs by emphasising clinical effectiveness and cost-effectiveness of treatments
• An efficient and effective procurement mechanism and supply chain network of quality medicines
• An efficient financing management mechanism for optimising health outcomes to ensure value for money
AVAILABILITY OF MEDICINE
A) SELECTION OF MEDICINES
Strategy 1 : National Medicines Formulary
Strategy 2 : National Essential Medicines List (NEML)
Strategy 3 : Drug and Therapeutic Committee
Strategy 4 : Traditional and Complementary Medicines Formulary
Strategy 5 : Life-saving Medicines and Orphan Medicines
Strategy 6 : Halal Medicines
B) SUPPLY OF MEDICINES
Strategy 1 : Procurement
Strategy 2 : Distribution and Storage of Medicines
Strategy 3 : Disposal of Medicines
Strategy 4 : Medicines Supply in Emergency Situations and Medicines Donations
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012 15
AFFORDABILITY OF MEDICINE
A) NATIONAL PRICING REFERENCE FOR MEDICINES
Strategy 1 : Transparency on Price Information
Strategy 2 : Monitoring of Price Information
Strategy 3 : Tariffs and Duties
B) FINANCING FOR MEDICINES
C) GENERIC MEDICINES POLICY
Strategy 1 : Prescribing in Generic International Non-proprietary Name (INN)
Strategy 2 : Procurement in Generic International Non-proprietary Name (INN)
Strategy 3 : Selection for Procurement
Strategy 4 : Generic Labelling Practice
Strategy 5 : List of Interchangeable and Non-interchangeable Medicines
Strategy 6 : Generic Medicine Substitution
Strategy 7 : Promoting the Use of Generic Medicines
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 201216
AVAILABILITY OF MEDICINES
A) SELECTION OF MEDICINES
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Establish National Pharmacoeconomic implementation road map
2014 Roadmap formed Road map National Health Economic
MOH, MOD,MOE, private hospitals, PhAMA, MAPS, MOPI, academicians, service provider (e.g.: CRO)
2. Implementation Road Map:Phase Ii) Prioritise the therapeutic area for pharmacoeconomics evaluation
2014 – 2017 Number of therapeutic area identified
Minimum 1 therapeutic area/ year
ii) Submission of PE local data for review of formulary
Number of local PE study
Minimum 1 local PE study
iii) Establishment of Centre of Pharmacoeconomics
Number of PE centres Number of experts identified and appointed
1 PE centre Minimum 5
Phase IIIdentify and appoint experts from MOH, MOE, MOD
2016 – 2017
Strategy 1: National Medicines Formulary
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. a) Form NMF revision committee (temporary committee)
2014 – 2015 Committee formed Committee formed by 2015
MOH, MOD, MOE, PhAMA, MAPS, MOPI, APHM, FPMPAM, academicians, service provider (e.g.: MCO)
b) Development of guideline for inclusion of medicines into the NMF
2016 Guideline developed Guideline developed by 2016
c) Establish NMF 1st draft 2016 – 2017 NMF drafted NMF draft ready by 2017
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012 17
Strategy 2: National Essential Medicines List (NEML)
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. a) Periodic multisectoral discussions to revise and update NEML every 2-3 years
2014 and 2017 Number of revisions done
2 times(2014 and 2017)
MOH, MOE, MOD, PhAMA, MPS, APHM, MOPI, *FPMPAMb) Publication of 4th
edition of NEML2014 NEML 4th edition
publishedNEML ready to be used by 2014
c) Conduct NEML awareness to stakeholders
2015 Number of sessions organized
50 sessions (follow DUNas target)
Strategy 3: Drug and Therapeutic Committee
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Form / enhance National *Drug Therapeutic Committee (NDTC)
2014 – 2015 Committee formed Committees formed, TOR formulated and functioning by 2015
MOH, MOE, MOD, APHM
2. Form / enhance *Drug Therapeutic Committee of institutions and local health facilities
2014 – 2015 Committee formed
* Drug to be changed to medicine
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 201218
Strategy 4: Traditional and Complementary Medicines Formulary
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. a) Set up technical working group comprising health and traditional practitioners, experts in phytotherapy, pharmacognosy, toxicology, herbal medicine and others
2017 TWG formed TWG formed by 2015
BPTK, FRIM, IMR, TCM associations, Traditional Practitioner Body, PSD, NPCB
b) Form National TCM Formulary committee
2017 Committee formed Committee formed by 2015
c) Formulate TOR for National TCM Formulary committee
2017 TOR formulated TOR formulated by 2017
d) Establish a framework and process of TCM Formulary
2017 Framework established
Framework ready by 2017
Strategy 5: Life-saving Medicines and Orphan Medicines
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Develop guidelines on handling of *orphan medicines and *life-saving medicines
2015 Guideline developed Guideline developed by 2015
PhAMA, MOPI, MAPS, MPS, BPP, MRDS
2. To review list of orphan medicines and life-saving medicines
On-going Official list available 2015
* Orphan medicine: for rare disease or not commercially viable to supply* Life-saving medicine: require for immediate administration within minutes post or during medical emergency
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012 19
Strategy 6: Halal Medicines
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. To review the Drug Registration Guidance Document (*Use of Halal Logo)
2014 Revision of Drug Registration Guidance Document (DRGD)
Document revised(**Use of Halal Logo)
NPCB
2. Awareness on MS2424: 2012 Halal Pharmaceutical-General Guideline and MS1900:QMS from Islamic Perspective to the industry stakeholders
2014 – 2016 Number of manufacturer exposed to MS2424: 2012 and MS1900: QMS
60 Manufacturers exposed to MS2424: 2012 and MS1900: QMS (100%)
NPCB
3. To create a list of Halal certified medicines with regular updates
2015 List of Halal certified medicines made available
List of Halal certified medicines made available by 2015
JAKIM
Previous DRGD:*Halal logo may be used voluntarily on registered product label for the following categories, for both local and export market, provided that such products have been certified and approved halal by the Malaysia Department of Islamic Development (Jabatan Kemajuan Islam Malaysia, JAKIM):
a) Non-scheduled poison, excluding parenteral dosage form and veterinary products;
(Reference: Circular (95)dlm.NPCB/PPP/01/03 Jld. 2)
b) Health supplements;
c) Natural products; and
d) Cosmetics
Current DRGD:** Halal logo may be used voluntarily on registered product label for the following categories, for both local and export market, provided that such products have been certified and approved halal by the Malaysia Department of Islamic Development (Jabatan Kemajuan Islam Malaysia, JAKIM):
a) Non-scheduled poison, excluding veterinary products;
(Reference: Circular (95)dlm.BPFK/PPP/01/03 Jld. 2; (6)dlm.BPFK/PPP/07/25 )
b) Health supplements;
c) Natural products; and
d) Cosmetics.
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 201220
B) SUPPLY OF MEDICINES
Strategy 1: Procurement
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Develop guidelines for medicine procurement process in public and private sector APHM, MPS, PSD, BPP, Bahagian Kewangan KKM, Association of Private Medical Practitioners, MCPG MOE, Ministry of Defence, PhAMA, MOPI, “Bumi agent association”
a) Form a committee and assign TOR
2014 Committee members appointed, TOR assigned
Yes
b) Mapping of existing procurement process (public and private)
2014 Procurement process mapped
Yes
c) Development of medicine procurement guideline
2014 – 2015 First draft of guideline developed
Yes by end of 2015
d) Publication of the procurement guidelines
2015 Guideline published and upload on stakeholder websites
Yes
e) Training of stakeholdersi) ToT to representative of all stakeholders
2015 – 2017 No. of ToT to representative of all stakeholders organised
2 ToT sessions
ii) Cascade training of the representative to the respective members
Percentage of respective members being trained
70%
f) Conduct a feasibility study to establish a national database of medicine availability
2015(to revisit at
midterm review)
Feasibility study done
Yes APHM, MPS, MOH, Association of Private Medical Practitioners, MCPG
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012 21
Strategy 2: Distribution and Storage of Medicines
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. To review shorter delivery lead time of tender drugs (not more than 21 days)
2015 MOH
a) To get baseline ratio based on existing central contract items based on delivery lead time (A=≤ 21 days, B=22-30 days, C=>30 days)
2014-2015 Baseline done(Ratio of each
category) (A:B:C)
Yes
b) Periodic tracking to identify the root cause for non-compliance
2014-2015 Percentage of root causes identified
100%
2. Establish an ICT system to support the supply chain network:• Public (MOH)- Pharmacy Information System/ Clinic Pharmacy System
Pilot 2014 Roll out 2016
PhIS/CPS rolled out nationwide according to schedule as stated in the concession agreement
Nationwide implementation of PhIS/CPS to be completed in 2016
MOH, Pharmaniaga
Strategy 3: Disposal of Medicines
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. To establish Pharmaceutical Waste Disposal Guidelines APHM, MPS, MOH (PSD, Bahagian Engineering), Association of Private Medical Practitioners, MCPG, DoE
a) Form a committee 2014 Committee formed Yes
b) Conduct workshop(s) to establish specific guideline for pharmaceutical waste disposal in: - Public hospitals - Private hospitals - GPs - Community pharmacies (with reference to EQA 1974)
2014 – 2015 Guidelines drafted Yes
c) Dissemination of guidelines to all stakeholders
2016 Guidelines disseminated
2016
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 201222
Strategy 4: Medicines Supply in Emergency Situations and Medicines Donations
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. To establish Medicines Donations Guideline MOH (PSD, Bahagian Pembangunan Kesihatan Keluarga, Bahagian Kawalan Penyakit), MERCY, MOD, PhAMA, MOPI, MAPS
a) Review the first draft 2014 Draft of guidelines to be reviewed and endorsed
2014
b) Endorse the revised guideline
2014
c) Publication of the guideline
2015 Guidelines published Yes
AFFORDABILITY OF MEDICINES
A) NATIONAL PRICING REFERENCE FOR MEDICINES
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. To develop National Pricing Reference for Medicines based on Recommended Retail Price (RRP)
2015 – 2017 Percentage of medicine with price in the National Medicine Formulary at the point of time (NMF based on commercially finished product available in the market)
2015 (70%) 2017 (80%)
MOH (PSD), MAPS, MOPI and PhAMA
Strategy 1: Transparency on Price Information
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Development of a medicines price database• Medicines Price Database shall be developed
2015 e-PHU (e- Pangkalan Harga Ubat/ electronic Drug Price Database) system is fully operational
Yes PSD
2. The availability of RRP for public access• Compulsory price reporting for RRP
2014 Percentage of registered products with RRP (controlled medicines and OTC products only)
2015 (70%) MOH, PhAMA, MOPI, MAPS and all other distributor/ manufacturers in Malaysia
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012 23
No. Activities Implementation Timeline Indicators Targets Stakeholder
3. Compulsory itemised billing indicating the price of each item bought or supplied at all dispensing channels
PSD, FOMCA, School of Pharmacy, Discipline of Social and Administrative Pharmacy, USM and CAP
a) To collaborate with relevant stakeholders in raising awareness on itemised billing of medicines
2014 Pre-survey Pre-survey:End of 2014
Post survey on awareness of itemised billing in collaboration with School of Pharmacy, Discipline of Social and Administrative Pharmacy, USM
Post-survey: 2016
b) Implementation of itemised billing for medicines by all dispensing channels
2015 Compliance rate among prescribing channels
2016 (70%)
Strategy 2: Monitoring of Price Information
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. To compare medicine wholesale price at local market with International Reference Price MSH/ WHO
2013 – 2017 Annual Price Analysis & Comparison report
Once per year
PSD, PhAMA, MOPI, MAPS
2. To collaborate with WHO in the creation of an ASEAN price database
2014 – 2015 ASEAN price database developed
2015 MOH, WHO and others
Strategy 3: Tariffs and Duties
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Continue to be exempted even with introduction of new tariffs
On-going Tariffs and duties on medicine
No tariffs and duties on medicine
MOH (PSD), MAPS, MOPI and PhAMA
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 201224
B) FINANCING FOR MEDICINES
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. To propose drug tariff reimbursement mechanism based on National Medicine Formulary
2014 - 2017 Drug Tariff reimbursement proposal developed
Yes MOH, PhAMA, MOPI, MAPS, FOMCA, CAP, health economist and other relevant stakeholders
2. To propose reimbursement list for claims made through public coverage (e.g. e-MASS) and other payers
2017 Reimbursement list developed
Yes MOH ( PSD, National Health Financing Unit (NHFU), JPA , MOF, LIAM, MTA, NIAM
C) GENERIC MEDICINES POLICY
Strategy 1: Prescribing in generic International Non-proprietary Name (INN)
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Generic Prescribing Survey (for government setting only)
Survey by 2014 Survey completed Yes MOH, MPS, Unit Kawalan Amalan
2. Generic Medicine Awareness Program (GMAP) nationwide Perubatan (UKAP), MMA, APHM, Federation of Private Medical Practitioners Association of Malaysia
i) Healthcare providers 2014 No. of seminars organised
1 seminar each state
ii) Consumers 2015-2017 Number of CME conducted
TBD
3. Generic prescribing to be enforced in new pharmacy law
Subject to the enactment of the new pharmacy law
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012 25
Strategy 2: Procurement of all medicines by generic INN
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Conduct a baseline survey that selection of medicine is made using generic name, i.e. quotations are made in generic name in all hospitals
2014 Survey conducted Yes MOH, APHM, MOE, MOD
Strategy 3: Selection for procurement in generic INN
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Annual monitoring and analysis of uptake volume of import generics vs. local generics based on the information by data provider
2014 Data is available Yes MOH, MOPI & IMS
Strategy 4: Generic Labelling Practice
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Carry out a study on generic labelling practice among GPs, retail pharmacy, hospitals and community clinics
2015 Survey findings are available by timeline
Yes MOH/ Enforcement
Strategy 5: Interchangeable and Non-interchangeable Medicines
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Development of non-interchangeable medicines list
2016 List of non-interchangeable medicine to be endorsed
List to be endorsed by 2015
MOH, MPS, MMA, APHM, MOE, MOD
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 201226
Strategy 6: Generic Medicine Substitution For All Interchangeable Medicines
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Generic substitution except for non-interchangeable medicine to be enforced in new pharmacy law
After the enactment of the Pharmacy Law
Provision in law to allow for generic substitution
Yes NGO, Consumer Association, MOH, MPS, MMA, APHM, UKAP, FPMPAM2. Raise awareness of the
new Pharmacy Law(Public engagement through NGOs and Consumer Association)
After the enactment of the Pharmacy Law
Strategy 7: Appropriate incentives to promote the use of generic medicines and their production in the country
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Expand the scope of GMAP to collaborate with other agencies to conduct activities that promote the use of generic medicines among consumers
2014 - 2015 No. of collaboration with other agencies
At least one collaboration activity organised
MOH, MPS, APHM, FPMPAM, consumer associations
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012
4. QUALITY USE OF MEDICINES
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 201228
4. QUALITY USE OF MEDICINES
POLICYQuality use of medicines is the responsibility of all stakeholders. Activities by relevant stakeholders in support of informed and appropriate use of medicines shall be encouraged and promoted.
AIM
• To ensure medicines are used judiciously, appropriately, safely and cost-effectively towards promoting better health outcomes.
STRATEGY The aim shall be achieved through:
• Development and implementation of models of best practice
• Education and training
• Provision of timely and accurate information on medicines
• Strengthening seamless care between public and private health care providers
• Research and development in quality use of medicines
• Engagement of payers involved in reimbursements for medicines use
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012 29
DEVELOPMENT AND IMPLEMENTATION OF MODELS OF BEST PRACTICE
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Identify existing pharmaceutical care activities for the private sector & non-MOH hospitals
2014 Survey done Yes MOH, MOE, MOD, MPS, APHM & relevant professional associations
2. Strengthen the involvement of pharmacists in the wards (medical & critical care)
On-going a) Percentage of MOH hospitals with pharmacist involvement in the wards
All MOH, MOE, MOD, MPS, APHM & relevant professional associations
On-going b) Percentage of non-MOH hospitals with pharmacist involvement in the wards
TBD (To get
baseline from
survey)
On-going c) Percentage of private hospitals with pharmacist involvement in the wards
TBD
3. Strengthen the involvement of pharmacists in ambulatory care – counselling
On-going a) Number of MOH facilities with pharmacists providing counselling
All MOH, MOE, MOD, MPS, APHM & relevant professional associationsOn-going b) Number of
Community Pharmacies providing counselling
TBD
On-going c) Number of private & non-MOH hospitals providing counselling
TBD
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 201230
No. Activities Implementation Timeline Indicators Targets Stakeholder
4. Strengthen the involvement of pharmacists in ambulatory care for chronic disease management – Medication Therapy Adherence Clinic (MTAC)
On-going a) Number of MOH facilities with pharmacists providing MTAC
All MOH, MOE, MOD, MPS, APHM & relevant professional associationsOn-going b) Number of
Community Pharmacies providing MTAC
TBD
On-going c) Number of private & non-MOH hospitals providing MTAC
TBD
5. Strengthening of Home Medication Review (HMR) activities in MOH facilities
On-going Number of facilities providing HMR services
Increasing trend
MOH
6. To conduct medication safety activities
On-going a) Number of hospitals with patient safety committees
Increasing trend
MOH
On-going b) Number of hospitals with medication safety activities
Increasing trend
7. To conduct antibiotic utilisation surveillance
2014 – 2015 Number of facilities Increasing trend
MOH, MOE, MOD, MPS, APHM & relevant professional associations
EDUCATION AND TRAINING
Strategy 1: Healthcare Providers
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Establishment of training centres with best practice in medical, critical care & MTAC
On-going Number of training centres
2 training centres for each speciality
MOH
2. Training of pharmacists in medical, critical care & MTAC
On-going Number of pharmacists trained
Increasing trend
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012 31
Strategy 2: Consumers
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Carry out projects and campaigns in collaboration with pharmacies / universities / MPS / NGOs to educate the public on the quality use of medicines
On-going a) Number of projects
1 project per year
MOH, Universities, NGOs, MPS, Community Pharmacies
On-going b) Incremental increase in level of knowledge and awareness
65% in 2015(Increment by 20% from baseline)
On-going c) Number of activities carried out by the private sector (community & hospital pharmacies)
Increasing trend
2. Carry out projects and campaigns for primary and secondary schools to educate students on the quality use of medicines
On-going a) Percentage of primary schools covered by projects and campaign
30% (2015) MOH, MOE
On-going b) Percentage of secondary schools covered by projects and campaigns
Increasing trend (From baseline in 2014)
3. Training of community leaders on the quality use of medicines through workshops
On-going Number of ToT sessions
8 ToT sessions per year
MOH
4. Educating specific target group by providing medication counselling & through medication therapy adherence clinics (MTAC)
On-going Percentage of MTAC diabetes patients who adhere to their medicines
Increasing trend
MOH
Strategy 3: Pharmaceutical Industry
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Covered under Component 1 (Governance in Medicines)
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 201232
Strategy 4: Media
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Seminar / dialogue on QUM concept and appropriate reporting aimed towards media personnel
On-going Number of seminars organised
1 training per year
MOH, Malaysian Communication & Multimedia Commission (MCMC), Reporters
PROVISION OF TIMELY AND ACCURATE INFORMATION ON MEDICINES
Strategy 1: Healthcare Providers
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Rebranding & enhancing the role of the National Pharmacy Call Centre (NPCC)
2015 Number of publications of information on new drugs
Increasing trend
MOH
Strategy 2: Consumers
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Promoting available access to medicine information (e.g., NPCC, Drug Info Committees (DIC) in hospitals, Know Your Medicine portal, MyHealth portal)
On-going Number of consumers seeking information from available information resources
Increasing trend
MOH
2. Dissemination of information to the general public through mass media, educational material and social media
On-going Number of topics disseminated
10 topics per year
Strategy 3: Pharmaceutical Industry
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Monitoring adherence to Medicines Advertising guidelines
On-going Percentage of compliance
100% PhAMA, MOPI, MAPS & other industry players
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012 33
Strategy 4: Media
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Develop guidelines on the responsible reporting on medicines by the media
2015-2017 Guidelines developed
Yes MOH, media
2. Screening & prompt response to misinformation in the media
On-going Percentage of responses delivered to the media within 24 hours
100%
STRENGTHENING SEAMLESS CARE BETWEEN HEALTHCARE PROVIDERS
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Provide comprehensive medication management system to improve monitoring of drug usage
2015 Percentage of identified facilities using Pharmacy Information System (PhIS)
100% MOH
RESEARCH AND DEVELOPMENT IN QUALITY USE OF MEDICINES
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Covered under Component 5 (Partnership & Collaboration for the Healthcare Industry)
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012
5. PARTNERSHIP AND COLLABORATION FOR THE HEALTHCARE INDUSTRY
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 201236
5. PARTNERSHIP AND COLLABORATION FOR THE HEALTHCARE INDUSTRY
POLICYPartnerships and collaboration in the implementation and strengthening of relevant areas in the healthcare industry shall be established among various stakeholders at the national, regional and international levels.
AIM
• To ensure that partnership and collaboration of all relevant stakeholders in the healthcare industry conforms to the best practices and standards pertaining to medicines at the national, regional and international levels.
STRATEGYThe aim shall be achieved by:
• Early and continuous engagement of all relevant stakeholders (Human Resource Development)
• Ensuring sustainability of qualified, competent and effective human resource based on needs through (Research and Development)
o Training and development
o Development and advancement of professional career pathway
• Sharing of information, expertise, skills and facilities (Technical Collaboration and Partnership)
• Developing a viable domestic and maintaining a responsible medicines industry (A viable and Responsible Pharmaceutical Industry)
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012 37
HUMAN RESOURCE DEVELOPMENT
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Incorporate DUNas policy into curriculum
2015 Engagement with MOE
Yes Pharmacy Board/ AKEPT/ Universities/ CollegesAgreement
from MOE for incorporation
Yes
2. Incorporation of DUNas policy as a compulsory module in the healthcare professional programmes
2017 Number of healthcare professional programmes incorporating DUNas policy as a compulsory module
All healthcare programs
Pharmacy Board/ Regulatory bodies/ Professional Associations/ Universities / Colleges
3. Implementation of DUNas online module in CPD programme
2015 – 2017 Number of health professionals passing the module
Increasing trend
Pharmacy Board / MPS/ MAP
4. Identify career opportunity and development for both private and public sector
2014 Career pathways determined for different industries
Yes Pharmacy Board, MAP, all stakeholders
5. Development of a structure for specialisation and recognition
2014 – 2017 Number of areas of specialisation identified
TBD Pharmacy Board, MAP, all stakeholders
Structure for recognition developed
Yes
RESEARCH AND DEVELOPMENT
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Identify priority areas to create incentives to attract more local and international R&D initiatives in Malaysia
2015-2017 Set criteria and incentives for drug utilisation & management
Yes NPCB, PhAMA, PEMANDU, CROs, CRM, CRC, MOPI, MOSTI, MOF, MIDA, Universities, etc.
2015-2017 Number of eligible research projects for incentives
3 projects
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 201238
TECHNICAL COLLABORATION AND PARTNERSHIP
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Identify areas and implement technical collaboration: Government agencies and private sectors, universities
a) Regulatory Practice 2015 No of MoUs with other countries
Yes
b) Market access (MOH, academy, industry)
2015 Number of health economic studies on utilisation of drugs
Yes
A VIABLE AND RESPONSIBLE PHARMACEUTICAL INDUSTRY
Strategy 1: Domestic Pharmaceutical Manufacturing
No. Activities Implementation Timeline Indicators Targets Stakeholder
1. Amendment on Patent Act (Acceptance of recommendations of the *I-Cells Study in 2011)
By 1st quarter of 2014
Paper tabled in the cabinet
Yes PEMANDU, Bahagian Dasar & Hubungan Antarabangsa, MOH
2. PEMANDU to work with MyIPO to:a) Build capacity & capability to provide timely filing of patents & accurate data for stakeholders
On-going Updated and current patent information data
Yes MyIPO, PEMANDU, Bahagian Dasar & Hubungan Antarabangsa, MOH, NPCB, MOPI, PhAMAb) Provide accurate
database information for users to track
On-going Timely patent filing Yes
3. Implementation of the off-take agreement
2013 - 2017 Number of off-take agreement
To be determined (based on consent from MOF)
MOF, Bahagian Dasar & Hubungan Antarabangsa, MOH, Bahagian Perolehan & Penswastaan MOH, NPCB MOH, PEMANDU, MIDA, MOPI
Number of products exported
*A Study on issues related to the Patent Law and Policy in Malaysia in relations to the domestic Pharmaceutical Industry
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012 39
LIST OF ORGANISING COMMITTEE MEMBERS
ChairmanDr. Nour Hanah binti Othman
Deputy Director (Pharmacy Policy & Management)Pharmaceutical Services Division
Organising CommitteeMs. Siti Aida binti AbdullahDeputy Director of Centre of Organisation DevelopmentNational Pharmaceutical Control Bureau
Ms. Anis binti TalibDeputy Director of Formulary & Pharmacoeconomic UnitPharmaceutical Services Division
Ms. Faridah binti Abdul MalekDeputy Director of Pharmaceutical Logistics UnitPharmaceutical Services Division
Ms. Salbiah binti Mohd SallehDeputy Director of Medicine Price UnitPharmaceutical Services Division
Ms. Abida Haq binti Syed M. HaqChief Pharmacist Hospital Kuala Lumpur
Ms. Hasnizan binti HasanSenior Principal Assistant Director National Medicine Policy Section (DUNas)Pharmaceutical Services Division
Ms. Sarah NagalingamPrincipal Assistant Director National Medicine Policy Section (DUNas)Pharmaceutical Services Division
Ms. Phuar Hsiao LingSenior Assistant Director National Medicine Policy Section (DUNas)Pharmaceutical Services Division
Ms. Nor Yati binti ZolkopriSenior Assistant Director National Medicine Policy Section (DUNas)Pharmaceutical Services Division
Ms. Melanie binti HassimSenior Assistant Director National Medicine Policy Section (DUNas)Pharmaceutical Services Division
Ms. Lau Ling WeiSenior Assistant Director National Medicine Policy Section (DUNas)Pharmaceutical Services Division
Mr. Khairul Iman bin MuzakirSenior Assistant Director Pharmaceutical Services Division
Mr. Muhamad Azlan bin BashirunSenior Assistant Director Pharmaceutical Services Division
Ms. Nur Azhana binti AbdullahSenior Assistant Director Pharmaceutical Services Division
Ms. Siti Fairuz binti Zulkefeli Senior Assistant Director Pharmaceutical Services Division
Mr. Ahmad Syafique bin Mohd SukarnoTechnicianPharmaceutical Services Division
Ms. Rosemah Shaik Ali@Sheikh HasanAdministrative AssistantPharmaceutical Services Division
Ms. Nur Syafira binti UzairiAdministrative AssistantPharmaceutical Services Division
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 201240
PANEL DISCUSSION MEMBERS
Dato’ Eisah binti A. RahmanSenior Director of Pharmaceutical Services
Ministry of Health, Malaysia
Mr. Mohd Hatta bin AhmadDirector of Pharmacy Enforcement Division
Ministry of Health, Malaysia
Dr. Salmah binti BahriDirector of Pharmacy Practice and Development Division
Ministry of Health, Malaysia
Mr. Tan Ann LingDirector of National Pharmaceutical Control Bureau
Ministry of Health, Malaysia
Mr. Yew Wei TarngPresident
Pharmaceutical Association of Malaysia, (PhAMA)
Mr. Leonard Ariff bin Abdul ShatarPresident
Malaysian Organization of Pharmaceutical Industries, (MOPI)
Mr. John ChangMalaysian Pharmaceutical Society (MPS)
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012 41
LIST OF PARTICIPANTSComponent 1 & 5:
Governance in Medicines & Partnership and Collaboration in the Healthcare Industry
• Group Leader : Dr. Nour Hanah Othman Deputy Director, U54 Pharmacy Policy and Management, MOH
Attendees :
No. Name Designation Stakeholder/ Agency/ Organization Representative
1 Azman Yahya Deputy Director, U54 Pharmacy Board, MOH
2 Siti Fauziah Abu Senior Principal Assistant Director, U52
Pharmacy Practice & Development, MOH
3 Salina Mohd Zamani Senior Principal Assistant Director, U52
Pharmacy Enforcement, MOH
4 Leona Tan Sze Ping Principal Assistant Director, U48
Pharmacy Practice & Development, MOH
5 Yusri Razalli @ Ghazali
Chief Senior Assistant Secretary
Bahagian Sumber Manusia, MOH
6 Lim Shean Lee Chief Assistant Secretary Bahagian Dasar & Hubungan Antarabangsa, MOH
7 Jong Koi Chong Assistant Secretary Bahagian Pengurusan Latihan, MOH
8 Prof. Dr. Mohamed Mansor Manan
Lecturer Universiti Teknologi MARA (UiTM)
9 Dr. Syed Ibrahim Mohd Ismail
Chief Executive Officer Malaysian Organization of Pharmaceutical Industries (MOPI)
10 Ewe Kheng Huat Executive Director Pharmaceutical Association of Malaysia (PhAMA)
11 Shamsuri Kadir Head of Public Affairs & Market Access
Pharmaceutical Association of Malaysia (PhAMA)
12 Prof. Madya Dr. M. Haniki Nik Mohamed
Principal, Malaysian Academy of Pharmacy & Head, Pharmacy Practice Department
Kulliyyah of Pharmacy, International Islamic University Malaysia (IIUM)
13 Haniza Anom Hashim Vice President, Legal & Regulatory, Strategy & Planning
Malaysian Biotechnology Corporation Sdn. Bhd.
14 Dr. Nik Musa’adah Mustapa
Senior Research Officer Forest Research Institute Malaysia (FRIM)
15 Hamim Hamdan Mustafa
Senior Assistant Director Malaysian Investment Development Authority (MIDA)
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 201242
Component 2: Quality, Safety and Efficacy of Medicines
• Group Leader : Puan Noorizam binti Ibrahim Deputy Director, U54 National Pharmaceutical Control Bureau (NPCB)
Attendees :
No. Name Designation Stakeholder/ Agency/ Organization Representative
1 Siti Aida Abdullah Deputy Director, U54 National Pharmaceutical Control Bureau (NPCB)
2 Mohd Zulkifli Abdul Latif
Deputy Director, U54 Pharmacy Enforcement, MOH
3 Ahmad Zakhi Ramli Senior Principal Assistant Director, U54
Pharmacy Enforcement, MOH
4 Azraini Abdul Samat Senior Principal Assistant Director, U52
National Pharmaceutical Control Bureau (NPCB)
5 Somiyaton Mohd Dahalan
Senior Principal Assistant Director, U52
National Pharmaceutical Control Bureau (NPCB)
6 Rohaida Zakaria Senior Principal Assistant Director, U52
Pharmacy Enforcement, MOH
7 Nurhayati Othman Senior Principal Assistant Director, U52
National Pharmaceutical Control Bureau (NPCB)
8 Norleen Mohamad Ali Principal Assistant Director, U48 National Pharmaceutical Control Bureau (NPCB)
9 Fazillahnor Ab Rahim Principal Assistant Director, U48 National Pharmaceutical Control Bureau (NPCB)
10 Manzatul Azrul Azrie Sulaiman
Principal Assistant Director, U48 Pharmacy Enforcement, MOH
11 Tee Khim Boon Senior Assistant Director, U44 National Pharmaceutical Control Bureau (NPCB)
12 Nor Yati Zolkopri Senior Assistant Director, U44 Pharmacy Policy and Management, MOH
13 Sabrina Haron Regulatory Affairs, Manager 1/ Pharmacist
CCM Duopharma Biotech Bhd.(represents MOPI)
14 Sumitha Ganasegaram
Regulatory Affairs Director GlaxoSmithKline Pharmaceutical (represents PhAMA)
15 J. S. Sunitha Dewi Regulatory Affairs Director GlaxoSmithKline Consumer Healthcare S/B (represents PhAMA)
16 Alice Chee Seat Mee Regulatory Consultant Pharmaceutical Association of Malaysia (PhAMA)
17 Lam Kai Kun General Manager Malaysian Pharmaceutical Society (MPS)
18 Zarrah Banu Hulwani Abdul Rahim
Technical & Regulatory Manager Amway (Malaysia) Sdn. Bhd. (represents DSAM)
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012 43
Generic Medicine Awareness Program (GMAP) nationwide
Component 3: Access to Medicines (Availability)
• Group Leader : Puan Anis binti Talib Deputy Director, U54 Pharmacy Practice & Development, MOH
Attendees :
No. Name Designation Stakeholder/ Agency/ Organization Representative
1 Faridah Abdul Malek Deputy Director, U54 Pharmacy Practice & Development, MOH
2 Dr. Faridah Aryani Md. Yusof
Senior Principal Assistant Director, U54
Pharmacy Practice & Development, MOH
3 Norhaliza A. Halim Senior Principal Assistant Director, U54
Pharmacy Practice & Development, MOH
4 Azuwana Supian Senior Principal Assistant Director, U54
Pharmacy Practice & Development, MOH
5 Dr. Mona Zaria Nasaruddin
Medical Specialist Institute of Respiratory Medicine, Hospital Kuala Lumpur
6 Rosliza Lajis Senior Principal Assistant Director, U52
Pharmacy Practice & Development, MOH
7 Sarawani Hassan Principal Assistant Director, U48 National Pharmaceutical Control Bureau (NPCB)
8 Lau Ling Wei Senior Assistant Director, U44 Pharmacy Policy & Management, MOH
9 Hisyam Yong Abdullah
Chief Assistant Secretary Bahagian Perolehan & Penswastaan, MOH
10 Wong Kuan Yeen Senior Assistant Director, U44 Bahagian Perubatan Tradisional & Komplementari, MOH
11 Safina Zainal Principal Assistant Director Jabatan Kemajuan Islam Malaysia (JAKIM)
12 Taqwa Zabidi Assistant Director Jabatan Kemajuan Islam Malaysia (JAKIM)
13 Aileen Chong General Manager, Vitacare Pharmacy
Malaysian Pharmaceutical Society (MPS)
14 Dr. Mohd Ilham Adenan
Senior Research Officer Forest Research Institute Malaysia (FRIM)
15 Lee Seng Dee Chief Pharmacist Pantai Holdings Berhad (represents APHM)
16 Stephanie Koh Market Access Manager Pharmaceutical Association of Malaysia (PhAMA)
17 Lily Lee MSO KAM & Market Access Head Pharmaceutical Association of Malaysia (PhAMA)
18 Henri Antaki Business Unit Director Pharmaceutical Association of Malaysia (PhAMA)
19 Masniza Mustaffa Health Coordinator MERCY Malaysia
20 Lee Xui Kin Registration Manager Malaysian Organization of Pharmaceutical Industries (MOPI)
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 201244
Component 3: Access to Medicines (Affordability)
• Group Leader : Puan Salbiah binti Mohd Salleh Deputy Director, U54 Pharmacy Practice & Development, MOH
Attendees :
No. Name Designation Stakeholder/ Agency/ Organization Representative
1 Fatimah Abdul Rahim Senior Principal Assistant Director, U54
Pharmacy Practice & Development, MOH
2 Saimah Mat Noor Senior Principal Assistant Director, U54
Pharmacy Practice & Development, MOH
3 Fatkhiah Hj. Khalil Senior Principal Assistant Director, U54
Pharmacy Practice & Development, MOH
4 Hasnizan Hasan Senior Principal Assistant Director, U54
Pharmacy Policy and Management, MOH
5 Rosilawati Ahmad Senior Principal Assistant Director, U54
National Pharmaceutical Control Bureau (NPCB)
6 Melanie Hassim Senior Assistant Director, U44 Pharmacy Policy and Management, MOH
7 Amrahi Buang Chief Pharmacist University Malaya Medical Centre (UMMC)
8 Ng Su Yee Chief Manufacturing & Technical Officer
CCM Pharmaceuticals Sdn. Bhd. (represents MOPI)
9 Rohan Talalla Head, Corporate & Government Affairs
GlaxoSmithKline Pharmaceuticals (represents PhAMA)
10 Kathleen Yeoh Head of Market Access & Patient Relation
Abbvie Sdn. Bhd. (represents PhAMA)
11 Noor Yang Azwar Kamarudin
Public Affairs & Communication Director
Pfizer (M) Sdn. Bhd. (represents PhAMA)
12 Hong Li Wen Manager Market Access Pfizer (M) Sdn. Bhd. (represents PhAMA)
13 John Chang Deputy President Malaysian Pharmaceutical Society (MPS)
14 Dr. Steven Chow Kim Weng
President Federation of Private Medical Practitioners’ Associations Malaysia (FPMPAM)
15 Zainal Abidin Lajat Manager KPJ Healthcare Berhad (represents APHM)
16 Dr. Choe Tong Seng Executive Director Malaysian Association of Pharmaceutical Suppliers (MAPS)
17 Ang Khoon Lim Managing Director, Pharm D. Sdn. Bhd.
Malaysian Association of Pharmaceutical Suppliers (MAPS)
18 Renuga Muniandy Pharmacist, KPJ Healthcare Bhd. Association of Private Hospitals of Malaysia (APHM)
19 Dr. T. Jayabalan Advisor The Consumers Association of Penang (CAP)
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012 45
Component 4: Quality Use of Medicines
• Group Leader : Puan Rosminah binti Md Din Deputy Director, U54 Pharmacy Practice & Development, MOH
Attendees :
No. Name Designation Stakeholder/ Agency/ Organization Representative
1 Rosminah Md. Din Deputy Director, U54 Pharmacy Practice & Development, MOH
2 Che Pun Bujang Deputy Director, U54 Pharmacy Practice & Development, MOH
3 Fuziah Abd. Rashid Senior Principal Assistant Director, U54
Pharmacy Practice & Development, MOH
4 Mazlan Ismail Senior Principal Assistant Director, U54
Pharmacy Enforcement, MOH
5 Dr. Siti Norlina Md. Said Chief Pharmacist, U54 Hospital Sultanah Aminah, Johor Bahru
6 Abida Haq Syed M. Haq Chief Pharmacist, U54 Hospital Kuala Lumpur
7 Normawati Muhammad Chief Pharmacist, U54 Hospital Tengku Ampuan Rahimah, Klang
8 Haji Abdol Malek Abd Aziz
Chief Pharmacist Hospital Tuanku Ja’afar, Seremban
9 Kol. A. Halim Haji Basari Pengarah Farmasi Health Services Division of Malaysia Armed Force HQ, MOD
10 Dr. Samsuddeen Abd. Aziz
Ketua Unit Projek Khas Ministry of Education
11 Phuar Hsiao Ling Senior Assistant Director, U44 Pharmacy Policy and Management, MOH
12 Yusni Rizal Dato’ Khairul Anuar
General Manager Pharmaniaga LifeScience Sdn. Bhd. (represents MOPI)
13 Norhana Nawawi Suri Regulatory Affairs Manager, Servier Malaysia Sdn. Bhd.
Pharmaceutical Association of Malaysia (PhAMA)
14 Andy Lee Public Affairs Manager Pharmaceutical Association of Malaysia (PhAMA)
15 Richard Leong Business Unit Director Pharmaceutical Association of Malaysia (PhAMA)
16 Yip Sook Ying Pharmacist Farmasi Alychem Sdn. Bhd. (represents MPS)
17 Dr. Azizan Abdul Aziz Honorary General Treasurer Malaysian Medical Association (MMA)
18 Prof. Madya Dr. Chua Siew Siang
Senior Lecturer Pharmacy Department, Faculty of Medicine, University of Malaya
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 201246
ABBREVIATIONS
ADR Adverse Drug ReactionAEFI Adverse Event Following ImmunisationAPHM Association of Private Hospitals MalaysiaAPI Active Pharmaceutical IngredientAPPL Approved Product Purchase ListASEAN The Association of Southeast Asian NationsBE BioequivalenceBIMST-EC Bay of Bengal Initiative for Multi Sectoral Technical and Economic CooperationBPP Bahagian Perkembangan Perubatan BPTK Bahagian Perubatan Tradisional dan KomplementariCD Compliance DataCMA Compliance Monitoring AuthorityCoC Code of ConductCPD Continuing Professional DevelopmentCPG Clinical Practice GuidelinesCRC Clinical Research CentreCRM Clinical Research MalaysiaCRO Contact Research OrganizationDCA Drug Control AuthorityDE Data ExclusivityDSAM Direct Selling Association of MalaysiaDUNas Dasar Ubat NasionalEDQM European Directorate for the Quality of MedicinesEQA Environmental Quality ActEU European UnionFPMPAM Federation of Private Medical Practioners’ Associations MalaysiaFRIM Forest Research Institute MalaysiaGCP Good Clinical PracticeGDP Good Distribution PracticeGGM Good Governance for MedicinesGLP Good Laboratory PracticeGMAP Generic Medicines Awareness ProgrammeGMP Good Manufacturing PracticeGSP Good Storage PracticeICSR Individual Case Safety ReportsICT Information and Communication TechnologyIMR Institute of Medical Research MalaysiaINN International Nonproprietary NamesIRP International Reference PriceJAKIM Jabatan Kemajuan Islam MalaysiaKPI Key Performance IndicatorLIAM Life Insurance Association of MalaysiaMAB Medicines Advertisement BoardMAD Mutual Acceptance DataMAP Malaysian Academy of PharmacyMAPS Malaysian Association of Pharmaceutical Suppliers
MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012 47
MCMC Malaysian Communications and Multimedia CommisionMCO Managed Care organisationMIDA Malaysian Investment Development AuthorityMOD Ministry of DefenceMOE Ministry of EducationMOF Ministry of FinanceMOH Ministry of HealthMOPI Malaysian Organisation of Pharmaceutical IndustriesMOSTI Ministry of Science, Technology & InnovationMoU Memorandum of UnderstandingMPR Median Price RatioMRDS Malaysian Rare Disorders SocietyMSH Management Sciences for HealthMTA Malaysian Takaful AssociationMTAC Medication Therapy Adherence ClinicMyIPO Intellectual Property Corporation of MalaysiaNCE New Chemical EntityNDRA National Drug Regulatory AuthorityNDTC National Drug & Therapeutic CommitteeNEML National Essential Medicine ListNIAM National Insurance Association of MalaysiaNMF National Medicine FormularyNPCB National Pharmaceutical Control BureauNPCC National Pharmacy Call CentreOECD Organisation for Economic Cooperation and DevelopmentOTC Over-the-counterPE PharmacoeconomicsPEMANDU Performance and Delivery Unit, JPMPhAMA Pharmaceutical Association of MalaysiaPhIS Pharmacy Information SystemPIC/S Pharmaceutical Inspection Co-operation SchemePMAS Post Marketing Surveillance Alert SystemPSD Pharmaceutical Services DivisionQC Quality ControlQUM-C Quality use of medicines – consumerRAS Rapid Alert SystemRRP Recommended Retail PriceSPOC Single Point of ContactSSFFC Substandard/ spurious/ falsely-labelled/ falsified/ counterfeitTCM Traditional and Complementary MedicineToT Training of TrainersTOR Term of ReferenceTWG Technical Working GroupUHC Universal Health CoverageWHO World Health OrganizationWHO/ HAI World Health Organization / Health Action InternationalWPRO World Health Organization Regional Office for the Western Pacific
Pharmaceutical Services DivisionMinistry of Health Malaysia
Lot 36, Jalan Universiti, 43650 Petaling Jaya, Selangor
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