updates on nra strengthening activities by who · dr. nora dellepiane, rss/rht/emp updates on nra...

Dr. Nora Dellepiane, RSS/RHT/EMP

Updates on NRA strengthening activities by WHO

Vaccine Industry Consultation

UNICEF, Copenhagen 8 and 9 October 2104

Dr. Nora DellepianeCoordinator Regulatory Systems StrengtheningEssential Medicines and Health Products

Dr. Nora Dellepiane, RSS/RHT/EMPDr. Nora Dellepiane, RSS/RHT/EMP

EMP restructuring process

• The quality, safety and standards team (QSS) from the Immunization, Vaccines and Biologicals (IVB) Department was transferred to the Essential Medicines and Health Products Department (EMP) in November 2012

• Subsequently, EMP was restructured. The objective of this process was to align policies, objectives, strategies and procedures for strengthening regulatory capacity for all medical products and health technologies.


EMP in the WHO hierarchy

Director General

HIS Cluster

EMP Department

RHT

SAV RSS TSN PQT

PAU PHI

HIS: Health systems and Innovation

EMP: Essential Medicines and Health

Products

RHT: Regulation of Medicines and other

Health Technologies

PAU: Policy, Access and Use

PHI: Public Health, Innovation and

Intellectual Property

SAV: Safety and Vigilance

RSS: Regulatory Systems Strengthening

TSN: Technologies Standards and Norms

PQT: Prequalification

(M. Chan)

(N. Dellepiane)(C. Ondari)

(M.P. Kieny)

(L. Rago)

(D. Wood) (?)

(C. De Joncheere)

(G. Forte) (Z. Mirza)


Strategic Objectives of RSS

1. Functional national regulatory systems developed and sustained

2. Regional regulatory systems developed and converged and regulatory requirements harmonized.

3. Regulatory networks developed and sustained

4. Accelerate access to products in greatest need through support to countries to ensure appropriate regulatory oversight of such products


WHA 67.20 resolution

• A WHA resolution on regulatory systems strengthening endorsed in May 2014 re-enforces WHO and member states' commitment to strengthen regulatory systems worldwide.

– It mandates WHO to accelerate its efforts in supporting the strengthening of regulatory systems in countries, regions and at global level and to foster networking, and regulatory convergence and collaboration

In line with RSS strategic objectives,

but more human and financial resources are

required


Addressing WHA resolution mandate

Process launched to ensure that WHO NRA policy, assessment process and assessment tool used in the WHO global programme for strengthening NRAs are updated as needed to seek integration and convergence for all product categories and that strengthening efforts are aligned across WHO (HQ, ROs and COs) to better serve the needs of member states.


Strategic Objective 1

Functional national regulatory systems developed and sustained Policy related aspects:1. Develop a WHO-wide policy for strengthening regulatory capacity

• Functionality requirement across all PQ programmes?

• Use of 5-steps capacity building model across all product categories?

• How to prioritize efforts? Which countries? Which functions?

• "Authorities of Reference" (AMRO) and "functionality" (are theyequivalent or different?)

• Need for harmonized terminology

• External assessment vs. Self-assessment

• Purpose of NRA assessment tool (capacity building, functionality, other)


Strategic Objective 1 (cont)Process related aspects

2. Revise the assessment process to meet current needs• All steps from planning to outcome

4. Conduct assessments for medicines and vaccines in prioritycountries , develop Institutional Development Plans, providetechnical support and monitor progress (China, India, Vietnam, selected African countries, etc)

5. Technical support and training provided to other countries as needed. (GLO, in country training, placements, on site consultants, joint review initiatives, and other capacity building means)


Strategic Objective 1 (cont)Tool related aspects

2. Combine all existing tools into a single NRA assessment toolto be used for all needs and product categories and revisethe indicators


Harmonization ‘s efforts among several products categories and health technologies areas to develop one WHO common assessment tool

Vaccine2011

Medicine

2011

PAHO2012

HarmonizedMed. & Vac.2014

PAHO Abbreviated2014

Blood products2012

MedicalDevices2014

Function 7 15 9 11 9 14 9Indicator 51 99 74 170 67 68 126Sub-Indicators

181 636 560 363 164 252 605

Completed work ready for submission

to international consultation for

Endorsement in Dec.2014

Ongoing work to be completed by end of 2015


HIS Reorganisation &Move of QSS team from IVB to EMP Sept.2012

EMP reorganised & New teams establishedDec.2013

CoordinationWith PAHOJune 2014

Revised toolsPublishedMay 2014

Planning & concept paper for international consultation shared with all Ros, June 2014

Invitation toRequest expertsDesignations from ROS & NRAs, Aug.2014

Working Groups sessionsOct-Nov

Online mtg2-4 Dec 2014HQ F to F MeetingJan 12 to 152015

Process for policy development and tool and assessment process revision

2012 20142014

Harmonization of medicines, PAHO, diagnostics, medical devices , & vaccines tools



Regional regulatory systems developed and converged and regulatory requirements harmonized.

– Focus efforts on regional economic blocks or other regional efforts for regulatory convergence and harmonization (i.e. EAC, PANDRH, ASEAN, etc)



Regulatory networks developed and sustained1. Support to global networks, such as the Developing country

vaccine regulators network

2. Collaborate as resource members with the Developing country vaccine manufacturers network

3. Support to regional networks, such as the Regional Alliance , for NRAs in the Western Pacific Region, African Vaccine Regulatory Forum, PANDRH, SEARO Network of National Control Laboratories, etc as needed


1. Pandemic Influenza project with focus on 15 countries (majority in Africa)

2. Local Production and Access to Medicines and other Health Technologies (WHO/EC project)1. Capacity building and technical assistance for local production of selected essential

medical products for both regulatory authorities and manufacturers

3. Facilitate registration of IPV and bOPV for smooth introduction into the National Immunization Programmes (NIPs)as part of the endgame strategy for polio eradication

4. Assist countries to establish regulatory pathways for registration of medical products for emergency use (fast track procedures, waivers, other)

Strategic Objective 4Accelerate access to products in greatest need through support to countries to ensure appropriate regulatory oversight of suchproducts


POLIO ERADICATION AND ENDGAME

STRATEGIC PLAN

2013-2018

The Strategic Advisory Group of Experts on Immunization (SAGE),

recommended in 2012 the withdrawal of the type 2 virus

fom OPV. Use of bOPV for routine immunization

programmes in all countries, fwith introduction of at least

one dose of IPV

Weekly epidemiological record wer 8901

The last case of wild poliovirus type 2 (WPV2) was seen in

1999

88% of the total of the circulating vaccine derived

poliovirus (cVDPV) cases in recent years were caused by the

vaccine derived type 2 strain

Introduction of IPV by 2015 and bOPV by 2016 in all countries

Registration of IPV in countries becomes a MUST

www.who.int/immunization/diseases/poliomyelitis/inactivated_polio_vaccine/en/

www.polioeradication.org

http://www.who.int/immunization/diseases/poliomyelitis/inactivated_polio_vaccine/en/

http://www.polioeradication.org


Support to countries for registration of IPV

Three possible regulatory pathways:

– Recognition of prequalification status without further action: Registration waiver

– Recognition of prequalification status as the basis for country registration: Expedited review procedure

– Full review procedure independent from prequalification


Support to countries for registration of IPV

• Registration waiver

• Expedited review procedure

• Full review procedure

• No further action required from WHO

• Joint review meeting to support the process

• Joint review meeting to support the process


IPV licencing status

194 Countries

68 countries already use it

61 countries accept PQ without any extra evaluation

14 countries with unknown pathway

51 countries need registration for IPV

28 follow expedited process

10 countries have licenced at least one IPV product

18 countries are in process of licensing

23 follow full review

20 countries

Have licenced at least one IPV

product

3 countries are in process of licensing


Support to countries for registration of IPV following full review procedure

Joint review meeting scheduled in Morocco from 20 to 24 October 2014 to assist 7 countries in EMRO for facilitated registration of two IPV products (Sanofi and BBio, two days and a half each) with support from NRAs from country of origin

– IMOVAX 10-dose (Jordan and Morocco)

– BBio 1 and 5 dose (Egypt, Iran, Jordan, Morocco, Saudi Arabia, Tunisia and UAE)


Support to countries for the continued regulatory oversight of IPV

• Monitor progress with registration of IPV (meeting end 2014 deadline)

• Assisting countries as required for the review and approval of variations


Registration of bOPV for introduction in countries for routine use

bOPV has been used since December 2009 for campaigns, 4.5 billion doses administered (end 2013). Studies performed showed higher protection levels (seroconversion) than those seen with tOPV. WHO/PQ will review data for label change for use of bOPV in routine (once change is approved by NRAs of record).

WHO has been working to identify alternative options to the standard vaccine licensure process that facilitate timely introduction and proposes to• Seek a WHA resolution in 2015 WHA that would recommend that “in the unique

context of Polio as a public health emergency, all countries are requested to accept bOPV for use in their routine immunization programme on the basis of the prequalification granted by WHO” and that

• Countries are encouraged to start their own national registration process for bOPV, if required, as soon as the vaccine is prequalified and without delaying the introduction of this vaccine.


Addressing regulatory challenges

• A survey will be conducted to better understand current status in countries

– Based on outcome, guidance document to be developed to inform countries on possible changes to current regulatory framework

– Support to implement changes to be provided

– Propose global mechanism to support registration/conditional approval of products for emergency use


Thank you

PHOTO. Massimiliano Pugliese

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