Consultative meeting

Registrar of Medicines & Pharmaceutical Industry

Ms Mandisa Hela

Medicines Regulatory Affairs

Department of Health

4 September 2008

Overview

Pharmaceutical Industry: Compliance with cGMP

Available Assistance: dti Marketing Code of Medicines:

Proposed EDMS Other

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Pharmaceutical Industry:

Compliance with cGMP

Act 101 of 1965

Act 101 of 1965: Amendment 2003– Licensing of Manufacturers– Licensing of Wholesalers

Implementation: 2004– MCC issue licences 2004

History of GMP upgrade

Identify need for GMP upgrade– Medicines Control Council (MCC) – Industry: need for export– Jointly: Industry and MRA /MCC to obtain PIC/S

membership GMP Guideline update

– Previous GMP Guideline: 1998– PIC/S GMP Guideline adopt and adapt – Workshop with Industry PIC/S GMP Guideline

[12 workshops] Jan 2004-Jan 2005 – Compare GMP Guide to PIC/S Guide – Incorporated Industry comment into PIC/S Guideline

History of GMP upgrade

GMP Guideline….cont – MCC published updated GMP Guideline: Nov

2005– Agreed-to Timeline with Industry for

implementation: 6 months– Inspection commencement: June 2006

History of GMP upgrade….cont

Identified specific areas of non-compliances:

HVAC Self-inspections & Contract audits Validation

– Conference re specific aspects of guideline: February 2006

– MCC open-door policy to advise

Current GMP status

Type Total No. Compliant Under Review

MNC 8 8 0

Generic 32 16 16

Closed 4 (Generic)

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Assistance: dti

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Marketing Code of Medicines: Proposed

Marketing Code of Medicines

Medicines Act: Section 18C

Enforceable Code of Practice for the Marketing of Medicines

Comment: Marketing Code of Medicines

Proposed Marketing Code excludes:– Veterinary medicines– Complementary medicines

Reference to legislation– Text general e.g. “Minimum requirements”– Spirit of code seems to support any efficacy claim

with substantiation / reference

Comment: Marketing Code of Medicines

Marketing wording: “Safe” / “Natural”– MCC registers: safety, efficacy and quality – Natural versus manipulation – Natural does not translate to “Safe”

Clinical trials – Text confusing / registered medicines?

Quotations– Text confusing / unregistered indications?

Conclusion: Marketing Code of Medicines

Thanks to Industry for the effort Clarification on issues raised Communication with the MRA Draft Amendment Bill of Act 101 states there

“shall” be an enforceable Code Details will be in Regulations and Guideline

documents – Comments invited

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EDMS

EDMS Workflow Specification and Software Configuration

Project

Slide 16

Information Information DatabaseDatabase

& Licensing& Licensing

Evaluators (150)Evaluators (150)Evaluators (150)Evaluators (150)

MCC Chairpersons (24)MCC Chairpersons (24)MCC Chairpersons (24)MCC Chairpersons (24)

Manufacturers (300)Manufacturers (300)Manufacturers (300)Manufacturers (300)

SSEECCUURREE

FFIIRREEWWAALLLL

SSEECCUURREE

FFIIRREEWWAALLLL

Internet

WWW

InternetInternet

WWWWWW

Secure InformationSecure InformationAdaptersAdapters

PVPVMedunsaMedunsa

General PublicGeneral PublicGeneral PublicGeneral Public

PharmacistsPharmacists

MedicalMedicalDoctorsDoctors

Other HealthcareOther HealthcareProvidersProviders

EDMS

LaboratoryLaboratoryBloemfonteinBloemfontein

Software Software VendorsVendors

ADRADRCape TownCape Town

ExternalExternalNRA AgenciesNRA Agencies

SiamedZizoCam

Clinical Trials & PV

CIS

CO

network &

Cabling

192Kb Diginet Line

& ISDN Backup

High Security & Climate Control

& backup power

Registry

Gr Fl (3)

Registry

Gr Fl (3)

Cluster Mgmt

2nd Fl (5)

Cluster Mgmt

2nd Fl (5)

Ops & Admin

2nd Fl (7)

Ops & Admin

2nd Fl (7)

MER

11th Fl (6)

MER

11th Fl (6)

CT & E

12th Fl (8)

CT & E

12th Fl (8)

I & LE

13th Fl (8)

I & LE

13th Fl (8)

Enquiries

2nd Fl (1)

Enquiries

2nd Fl (1)

Scanning

2nd Fl (1)

Scanning

2nd Fl (1)

Security Control & Encryption

Video Conferencing

3 x ISDN

Video Conferencing

3 x ISDN

PVPVBloemfonteinBloemfontein

LaboratoryLaboratoryPotchefstroomPotchefstroom

MCC Board

12th Fl (1)

MCC Board

12th Fl (1)

MRA Network Topology

Slide 17

It is expected that the EDMS Project will provide the following within the scope of the configuration contract :

– Conformance to local regulatory requirements

– Conform to international regulatory standards

– Conform to Government IT standards

– Ability to perform search and retrieval operations on the information stored in the system

– Ability to perform workflow management in-house

– Provide web-enabled centralised control

– Provide necessary tools to perform publication of updated information on website

– Provide ability to maintain security/control via digital signatures

– Ability to deliver version and iteration control

– Provide a clear archiving strategy

Slide 18

Major Indicators

• Local Industry acceptance will be key with particular attention:

- security, compatibility of IT systems

• Electronic process will satisfy environmental & archiving concerns

• Different Databases integration at MRA

• Project Management and transparent timeline management

• Knowledge Management (Management reporting, supervision and efficiency)

• Format cross indexing (MBR1 MRF1 eCTD)

• Work in progress, workshops, seminars to follow with all stakeholders

• Pilot planned: February 2009

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Schedules to Act 101

Schedules to Act 101: 5 Sept 08

Government Gazette– Newly developed entities

e.g. Human Papillomavirus vaccine (S4)– New designer drugs with abuse potential

e.g. 1-Benzylpiperazine (BZP) (S7)

Schedules to Act 101: 5 Sept 08

Rescheduling based on new information

Clotrimazole (S1),a.when intended for human vaginal use specifically for the

treatment of recurrent vaginal candidiasis; (S4) and

b.when intended for application to the skin. (S4)

Schedules to Act 101: 5 Sept 08

Improved descriptions

e.g. Hyaluronic Acids (S0, S1, S2, S4)– Hyaluronic acid and its salts (S1), when contained in

preparations containing 2,5 percent or more intended for topical application to the skin, except preparations containing less than 0,25 percent when intended for topical use in terms of the provisions of the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act 54 of 1972). (S0, S2, S4)

END

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