WHO role in building effective and efficient regulatory

systems for health products

WHO Regulatory Systems Strengthening Programme

Global context

3

Overall regulatory systems’ maturity level of WHO Member States

ML 1100 countries

51%ML 2

44 countries23%

ML 3 and 450 countries

26%

(Updated 8 Feb 2019)

WHO MVP/RSS/CRS

4

SDG 3 – Target 3.8

Achieve universal health coverage, including financial risk protection,

access to quality essential health-care services and access to safe,

effective, quality and affordable essential medicines and

vaccines for all.

Strategic Priorities

13th General Programme of Work 2019-2023

5

WHO TransformationMajor reorganization of WHO to deliver

the mission and strategic priorities of the 13th General Programme of Work

Health Products

Policy and

Standards

Regulatory and

Prequalification

• Access to assistive technologies & medical devices

• Medicines Selection, IP & Affordability

• INN & classification of medical products

• Quality, Safety & Efficacy

• Expert Committee on Drug Dependence

• Knowledge development

• Local production assistance

• Pharmacovigilance

• Prequalification

• Regulation and safety

Mission

•Promote Health•Keep the World Safe•Serve the Vulnerable

Division: Medicines & Health Products

1• build regulatory capacity in Member States

consistent with good regulatory practices

2

• promote regulatory cooperation, convergence and transparency through networking, work-sharing and reliance

6

Objectives of the WHO regulatory system strengthening programme

• WHA Resolution 67.20 in 2014

✓ recognized the importance of strong regulatory

systems to a well-functioning healthcare system

and the attainment of health-related SDGs and

UHC.

7

To continue to support Member States upon their request in the area of

regulatory system strengthening, including, as appropriate, by

continuing to:

Evaluate national regulatory systems

Apply WHO evaluation tools

Generate and analyze evidence of regulatory system performance

Facilitate the formulation and implementation of institutional development plans

Provide technical support to national regulatory authorities and governments

WHA Resolution 67.20 What WHO should do

8

WHA Resolution 67.20 What WHO should do

Norms and

standards

Medical devices

including

Diagnostics

Health system

strengthening

Capacity building

in developing

countries

ICDRA

International and

regional

collaboration

Networks

WHO

PQ program

Regulation of

complex

biological

9

WHO NRA 5 step capacity building

Development of NRA

benchmarking tool

Benchmarking of NRA

Formulation of Institutional

Development Plan (IDP)

Providing technical support,

Training/Learning, networking,

Monitoring progress and

impact

•M

inim

al cap

acit

y m

et

•E

lig

ibil

ity f

or

va

ccin

e P

Q

•W

HO

lis

ted

NR

As

1 2 3 4 5

10

Global context: different assessment tools collecting information from Regulatory Authorities and affiliated institutions

WHO RECOMMENDED REGULATORY FUNCTIONS FOR MEDICINES, VACCINES BASED ON PRODUCT LIFECYCLE

PRE MARKETING

Pre-clinical Clinical

Production

& Quality

Control

Marketing

and sales

Post-

Marketing

Non Common Regulatory

Function for vaccines and

blood products

Common

Regulatory Functions

for: medicines &

vaccines and blood

products

Next steps:

Medical devices and

blood products in

2019

POST MARKETING PRODUCT

LIFECYLCE

National Regulatory System (RS)

Regulatory Inspection (RI)

Laboratory access and Testing (LA)

Clinical Trial’s Oversight (CT)

Vigilance (PV)

Licensing premises

(LI)

Registration & marketing

authorization (MA)Market surveillance and

Control (MS)

NRA Lot release (LR)

13

WHO Global Benchmarking ToolStructure/Hierarchy

SUB-INDICATORS

INDICATORS

SYSTEM FUNCTION

THE FACT

SHEET

QUESTIONNAIRE FOR

OTHER PRODUCTS

/ACTIVITIES

14

WHO Global Benchmarking ToolStructure/Hierarchy

SUB-INDICATORS

INDICATORS

SYSTEM FUNCTION

THE FACT

SHEET

QUESTIONNAIRE FOR

OTHER PRODUCTS

/ACTIVITIES

INDICATORS

1. Legal provisions, regulations and guidelines

2. Organization and governance

3. Policy and strategic planning

4. Leadership and crisis management

5. Transparency, accountability and communication

6. Quality and risk management system

7. Regulatory process

8. Resources (HR, FR, Experts, Infrastructure, Equipment

and IMS)

9. Monitoring progress and assessing impact

Indicators Categorization (cross cutting subjects)

Categories enable assessment of cross sectional subjects (across

some and/or all functions)

15

Current Status of Regulatory Systems WHO Global Benchmarking (for medicines and vaccines: as of September 2019)

2

Advanced/referenceRegulatory Authorities

Can ensure the quality of products if rely on ML3 / ML4 regulatory systems

Target of WHA Resolution 67.2

100COUNTRIES

44COUNTRIES

50COUNTRIES 16

No formal approach

Reactive approach Stable formal system approach

Continual improvement emphasized

1 2 3 4

ISO

90

04

Regulatory system operating at advanced level of

performance and continuous improvement

Evolving national regulatory system

that partially performs essential regulatory functions

Stable, well-functioning and integrated regulatory system

Some elements of regulatory system exist

WH

O G

BT

17

Updated Figures of the WHO GBT revision VI

Item Function RS MA VL MC LI RI LA CT LRGrand

Total

Number of Sub-

Indicators60 35 26 27 19 26 28 30 17 268

Sub-Indicators

measuring maturity level

1

4 6 5 3 2 3 2 2 1 28

Sub-Indicators

measuring maturity level

2

7 2 3 4 1 2 2 8 3 32

Sub-Indicators

measuring maturity level

3

27 23 14 15 13 13 18 17 11 152

Sub-Indicators

measuring maturity level

4

22 4 4 5 3 8 6 3 2 56

Minimal

capacity

Advanced/r

eference

NRAs

18

Recommended activities to be included in Institutional Development (IDP)

Regulatory functions Total number of

Recommendations

No. of

recommendations

required to reach

ML3

01-NATIONAL REGULATORY SYSTEM (RS) 29 10

02-REGISTRATION AND MARKETING AUTHORIZATION (MA) 28 12

03-VIGILANCE (VG) 16 9

04-MARKET SURVEILLANCE AND CONTROL (MC) 10 1

05-LICENSING PREMISES (LI) 5 1

06-REGULATORY INSPECTION (RI) 13 4

07-LABORATORY ACCESS AND TESTING (LA) 3 1

08-CLINICAL TRIAL’S OVERSIGHT (CT) 15 10

09-NRA LOT RELEASE (LR) 5 2

Total 123 50

WHO/EMP/RHT/RSS/ NRA assessment group

Business model and new innovative approaches

Bench Marking

Development of NRA assessment

tool

Benchmarking of NRA

Development of Institutional

Development Plan (IDP)

Providing technical support, Training/Learning, networking, etc.

Monitoring progress and

impact

CIP

•M

inim

al

ca

pa

cit

y m

et

•E

lig

ibilit

y f

or

vaccin

e P

Q

•W

HO

lis

ted

NR

As

This will be achieved by • Identifying existing and potential partners with an interest in regulatory

strengthening;

• Establishment of a coordination mechanism among partners to develop

one agreed roadmap and/or institutional development plan (IDP).

China: The Success Story

20

2005 Mar/2011 Oct/2013 Q2/2014

NRA

Benchmarking

Functional NRA,

after benchmarking

in Dec 2010

NRA

Re-Assessment

IDPIDP

More

vaccine

submitted

for PQ

1st PQ vaccine

21

Tanzania: The Success Story

22

Overall regulatory systems’ maturity level of WHO Member States

ML 1100 countries

51%ML 2

44 countries23%

ML 3 and 450 countries

26%

(Updated 8 Feb 2019)

WHO MVP/RSS/CRS

23

System &

Functions

Regulator

• Benchmarking (GBT)

• Performance evaluation of

regulators

• Global competency

framework (draft)

Training

Specialized

technical

support

• WHO guidelines related to

regulatory functions (MA,

RI, VL, QMS, LR, etc.)

• Global and regional

networks

• GRP & GRelP guidelines

• WHO Listed Authority

(WLA)

• Variety of trainings for

regulators in various areas

including theoretical and

hands on

• Provide technical support

to advise on regulatory

matters

Benchmarking

(Gap analysis)

Capacity

building

Smart

regulation

Guidelines

Promoting

harmonization

and GRP

Promoting

reliance

Countries benchmarked against GBTJan 2016 - Sep 2019

* in accordance with United Nations Security Council resolution 1244 (1999)

The boundaries and names shown and the designations used on this map do not imply the expression of any opinion whatsoever on the part of the World Health Organization (WHO) concerning the

legal status of any country, territory, city or area of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on map represent approximate border lines for which there

may be not yet be full agreement.

(Updated Sep 2019)

• India

• Papua new guinea

• Timor-Leste

• Tanzania

• Burundi

• Mozambique

• Ethiopia

• Kenya

• Djibouti

• Eritrea

• Sudan

• Somalia

• Uganda

• South Sudan

• Afghanistan

• Pakistan

• Malaysia

• Japan

• Iraq

• Jordan

• Lebanon

• Mongolia

• Kyrgyzstan

• Syria

• Korea

• Bangladesh

• Iran

• Egypt

• Saudi Arabia

Self BenchmarkingFormal Benchmarking

• Maldives

• Nepal

• Sri Lanka

• Bhutan

• Guinea Bissau

• Liberia

• Niger

• Cape Verde

• Gambia• Serbia

• Burkina Faso

• Benin

• Guinea

• Togo

• Mali

• Cote d’ivoire

• Senegal

• Sierra Leone

• Cambodia

• Lao PDR

• Thailand

• Indonesia• Montenegro

• Macedonia

• Bosnia and Herzegovina

• Albania

• Kosovo area*

• Kazakhstan

• Vietnam

• Rwanda

• Turkey

• China

• Eswatini

• Comoros

• Madagascar

• Malawi

• South Africa

• Zambia

• Botswana• Lesotho

• Namibia

• Seychelles

• Zimbabwe

• Congo DR • Angola

• Mauritius

• Ghana

• El Salvador

• Nigeria

25

Go to our Regulatory system strengthening website

Go to SharePoint site

Go to the Global Benchmarking Tool

Go to GBT online training

Important Links

Thank you

Dr Alireza Khadem

Email: khadembroojerdia@who.int

Regulatory Systems Strengthening (RSS)

Regulation of Medicines and Other Health Technologies (RHT)

World Health Organization (Geneva, Switzerland)

WHO/EMP/RHT/RSS/ NRA assessment group

• Responds to requests from Member States for guidance on how to develop

legal frameworks

• Foundational document that applies internationally accepted principles of GRP

to the regulation of medical products

• Relevant to all regulators, irrespective of resources and system

(centralized/decentralized/network)

• Concept development workshop, India in June 2014

• Presentation to ECSPP on way forward requesting input

(October 2017)

WHO draft Guideline on GRP

▪ Attended by Regulators from 13 Member States, WHO (HQ & Ros), others

▪ Objectives – to discuss and agree on the structure and elements of the future

WHO GReP guideline

▪ Discussions informed by survey report by the International Pharmaceutical

Regulators Programme (IPRP) on reliance and the PAHO/AMRO concept note

on reliance

▪ Outcome

✓ PAHO/PANDRH concept note should be used for the development of a WHO GRelP

document

✓ The meeting underscored the importance of reliance

➢ in addressing the challenges of regulation in a complex, global regulatory environment

and in adopting ‘smart’ regulatory approaches

➢ GRelP is one of a suite of best practices guidances for regulatory authorities.

International meeting on GRelPGuidelines, 19 Sept 2019

▪ Results from surveys and assessments of NRAs by WHO in several countries, called for:

✓ Guidance on establishment, implementation and maintenance of QMS in national regulatory

systems;

✓ WHO QMS guidance document with particular attention to NRAs in low- and middle-income

countries (LMICs)

▪ Development of a WHO guideline on implementation of QMS initiated in 2018

✓ Addressing inefficiences in regulatory processes and services

▪ Drafting Group formed and produced the first draft

▪ Two public consultations in 2019, face to face meeting in June 2019

▪ Draft guideline endorsed during the 54 ECSPP meeting held from 14 – 18 Oct 2019

WHO guideline for implementation of QMS by NRAs

▪ Network serves to promote best practices

✓ build capacity and facilitate a reduction in lot release testing on the part of

vaccine importing countries

➢ Through a reliance on test information from the NCLs of vaccine

producing countries through a secure platform and system of

confidentiality agreements

➢ Thereby promoting recognition of and access to WHO prequalified

vaccines globally

▪ Third General Meeting in Johannesburg, South Africa 5-7 November 2019

✓ Continues to expand membership

▪ More Network information is available at the WHO internet at:

http://www.who.int/immunization_standards/vaccine_quality/who_nnb/en/

WHO NCL Network for Biologicals

WHO/EMP/RHT/RSS/ NRA assessment group

▪ Term ‘Stringent Regulatory Authority’, defined as original ICH member/observer,

developed to guide procurement decisions

▪ Widely used and recognized

▪ However growing concerns with term SRA; with the fact that ICH doesn’t have

remit or competence to assess regulatory capacity; coupled with expanding

membership

▪ WHO expert committee considered new WHO proposal in October 2017

A new proposal aimed at promoting reliance - WHO Listed Authority

31