HIS | EMP | RHT | RSS | CRS www.who.int

WHO Regulatory Systems Strengthening Program Presented by: Alireza Khadem

WHO/HIS/EMP/RHT/RSS/CRS

WHO Technical Briefing Seminar, 2017

Sustainable Development Goals

WHA Resolution for regulatory System Strengthening

WHO regulatory system capacity building model

WHO Global Benchmarking Tool

Minimum Required Regulatory Functions

Innovative Approaches Toward Regulatory System Strengthening

Challenges

Global overview

12/10/2017 2

Outline

12/10/2017 3

12/10/2017 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.

12/10/2017 5

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

12/10/2017 6

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

WHO capacity building model

12/10/2017 8

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

Min

imal cap

acit

y m

et

Vaccin

e:

eli

gib

ilit

y f

or

PQ

1 2 3 4 5

Re-benchmarking Based on a risk management

approach

Revision of indicators &

benchmarking process

With or without a road map for

prequalification of products

WHO support through: Global Learning

Opportunities (GLO)

Technical Support In-country training Networking Harmonization

WHO electronic platform to monitor

NRAs information and benchmarking, IDP, training, etc.

12/10/2017 9

From gap analysis to capacity building

9

Gap

analysis

• Assessment report

IDP

• Recommendations & activities to address it

Addressing gaps

• Providing technical support

• Learning/Training/international cooperation

Monitoring progress and

impact

• IDP follow-up : progress and impact

• Re-assessment to sustain PQ or NRA functionality until expected maturity is achieved

Global Learning

Opportunities (GLO)

In-county workshop

Technical Support and on

site consultan

ts

Placement, joint review

, twining, others

Regulatory functions targeted: 1.NATIONAL REGULATORY SYSTEM

2.REGISTRATION AND MARKETING

AUTHORIZATION

3.LICENSING OF PREMICES

4.MARKET SURVEILLANCE AND CONTROL

5.VIGILANCE

6.REGULATORYINSPECTIONS

7.CLINICAL TRIALS OVERSIGHT

8.LABORATORY ACCESS AND TESTING

9.NRA LOT RELEASE

12/10/2017 | WHO National Regulatory Authorities Global Benchmarking Tool (GBT) and pathway for regulatory systems strengthening 10

WHO NRA Benchmarking Policy Benchmarking Methodology

Benchmarking Pre visit Self benchmarking Follow up and Monitoring

Pre IDP

Observed Audit

Vigilance field visit

IDP implementation (Monitoring + Capacity building activities)

Validation of information

WHO Global Benchmarking Tool

Legal

framework

mandate and

enforcement

power

Norms and

standards

Leadership,

coordination

& Strategic

Planning

Quality

Management

/Risk

Management

System

Resources

HR, FR, IMS,

Infrastructure

Access to Affordable Medical Products

Assuring quality of products

Quality control/testing

Inspection/Audit and

Enforcement

Vigilance and Surveillance

Scientific evaluation and

oversight

Competency Independency Transparency

12/10/2017 13

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

PRE MARKETING

Pre-clinical Clinical

Production

& Quality

Control

Marketing

and sales

Post-

Marketing

Non Common

Regulatory

Functions (vaccine)

Common

Regulatory Functions

for: medicines &

vaccines (2015)

Next steps: Medical

devices, Blood &

(2017)

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)

12/10/2017 14

WHO Global Benchmarking Tool Structure/Hierarchy

SUB-INDICATORS

INDICATORS

SYSTEM FUNCTION

THE FACT

SHEET

QUESTIONNAIRE FOR

OTHER PRODUCTS

/ACTIVITIES

12/10/2017 15

WHO Global Benchmarking Tool Structure/Hierarchy

SUB-INDICATORS

INDICATORS

SYSTEM FUNCTION

THE FACT

SHEET

QUESTIONNAIRE FOR

OTHER PRODUCTS

/ACTIVITIES

National Regulatory System (NRS) and Functions (NRF)

SYSTEM FUNCTION

1. Regulatory System + Common Function 2. Non Common Functions

Common Function Non Common Functions

01-NATIONAL REGULATORY SYSTEM 02-REGISTRATION AND MARKETING AUTHORIZATION 03-VIGILANCE 04-MARKET SURVEILLANCE AND CONTROL 05-LICENSING PREMISES 06-REGULATORY INSPECTION 07-LABORATORY ACCESS AND TESTING 08-CLINICAL TRIAL’S OVERSIGHT

09-NRA LOT RELEASE

12/10/2017 16

WHO Global Benchmarking Tool Structure/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)

12/10/2017 17

WHO GBT Performance Maturity Levels

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

Can be consider as functional if

rely on other regulators for some

specific functions

Target of WHA

Resolution 67.20

Advanced/reference

Regulatory Authorities

WH

O G

BT

12/10/2017 18

Model for adoption of Maturity Level Concept Maturity Level Spider Web

• By adoption of the maturity level

concept, gaps are easily figured out

(inter-and-intra regulatory functions)

and hence capacity building

priorities are defined as shown in

this example!

• In addition, maturity level adoption

enable customization of the tool for

benchmarking of NRAs of varying

capacities.

0

1

2

3

4

5RS

MA

VL

MC

LI

IN

LA

CT

Maturity Level

12/10/2017 19

Recommended activities to be included in Institutional Development (IDP)

Regulatory functions Total number of

Recommendatio

ns

No. of

recommendation

s 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

Country IDP implementation estimated cost

Function/ area for Regulatory Strengthening Current

Maturity Level Estimated cost to

reach to Maturity

level 3

1. National Regulatory System (RS) 1 330,000 USD

2. Registration and Marketing Authorization (MA) 2 180,000 USD

3. Vigilance (VL) 1 240,000 USD

4. Market Surveillance and Control (MC) 1 450,000 USD

5. Licensing Premises (LI) 2 150,000 USD

6. Regulatory Inspection (RI) 2 450,000 USD

7. Laboratory Access and Testing (LA) 2 750,000 USD

8. Clinical Trials Oversight (CT) 1 450,000 USD

9. NRA lot Release NA 0 USD

Total estimated cost 3,000,000 USD

China: The Success Story

2005 Mar/2011 Oct/2013 Q2/2014

NRA

Benchmarking Functional

NRA, after

benchmarking

in Dec 2010

NRA Re-

Assessment

IDP IDP

1st PQ vaccine

More vaccine

submitted for PQ

Minimum Required Regulatory Functions

12/10/2017 23

a) Thru reliance/recognition b) apply for GDP and may be GCP c) applies in case of CT performed in-country d) applies only for vaccines and blood products

Proposed core regulatory functions and minimum maturity level required according to the source of products

MINIMOM CAPACITY

Innovative Approaches Toward Regulatory System Strengthening

12/10/2017 25

The Future: new business model and innovative approaches

Development of NRA

benchmarking tool

Benchmarking of NRA

Formulation of Institutional

Development Plan (IDP)

Providing technical support, Training/Learning,

networking,

Monitoring progress and

impact

Min

ima

l c

ap

ac

ity m

et

Va

cc

ine

: e

lig

ibil

ity f

or

PQ

1 2 3 4 5

Re-benchmarking Based on a risk management approach

Revision of indicators & benchmarking process

With or without a road map for prequalification of products

WHO support through: Global Learning Opportunities (GLO) Technical Support In-country training Networking Harmonization

WHO electronic platform to monitor NRAs information and benchmarking, IDP, training, etc.

CoRTE

CIP

Challenges

• Absence of national policy and strategic objectives for establishing

and/or developing further a National Regulatory Authority (NRA)

• Lack of minimum resources to establish and sustain regulatory

oversight

• Unclear vision and mission (what should be done and what should not)

• Avoiding duplication, reliance and recognition

• Regulatory activities that could be done collectively by countries

• Access vs. quality

• Long term process, required continues commitment and engagement

12/10/2017 27

Major challenges

Fact and figures GLOBAL OVERVIEW

12/10/2017 29

WHO NRA Assessment Visits: 1997

12/10/2017 30

WHO NRA Assessment Visits: 2014

12/10/2017 31

Countries targeted for WHO Regulatory System Strengthening Program 2016-2017:

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 25 September 2017)

India

Papua new guinea

Timor-Leste

Tanzania

Burundi

Mozambique

Ethiopia

Kenya

Djibouti

Eritrea

Sudan

Somalia

Uganda

South Sudan

Afghanistan

Pakistan

Vietnam

Malaysia

Japan

Iraq

Jordan

Lao’s PDR

Lebanon

Mongolia

Kyrgyzstan

Syria

Korea

Bangladesh

Cambodia

Iran

Kazakhstan

Egypt

Saudi Arabia

Self Benchmarking

Formal Benchmarking

Maldives Nepal Sri Lanka Thailand

Bhutan Indonesia

Ghana

Guinea Bissau

Liberia

Niger

Cape Verde

Gambia

Serbia

WHO/EMP/RHT/RSS/ NRA assessment group

STRENGTHENING NATIONAL REGULATORY AUTHORITIES (NRA) TRAINING CONDUCTED, 1996-2017 8068 PARTICIPANTS FROM NRAs, NCLs*, EPI** AND/OR VM

8068 head counts have been trained by WHO between

1996 till Sept. 2017

GLO, 2306, 29%

InCountry, 4079, 50%

Meeting, 1232, 15%

Other, 392, 5%

Placement, 59, 1%

12/10/2017 33

WARD, Michael Coordinator, HQ/HIS/EMP/RHT/RSS

wardmi@who.int

KHADEM BROOJERDI, Alireza khadembroojerdia@who.int

BROWN, Laura Kay brownl@who.int

YAP, Maria Bernadette yapm@who.int

OSTAD ALI DEHAGHI, Razieh ostadalidehaghir@who.int

ALFONSO, Claudia alfonsoc@who.int

REFAAT, Mohamed refaatm@who.int

EL HEMSY, Samir M.A. Abdel Wahab awahabs@who.int

Ahmed Samy ahmedsamy_who@yahoo.com

Alaa Magdy alaamagdy.who@gmail.com

CRS Group

12/10/2017 34

WHO HIS RSS

Mobile App Now Available on

Go to SharePoint site

Go to our website Go to GBT online training

https://workspace

.who.int/sites/att/

GBT_TrainingCB

T/story_html5.ht

ml

Thank you

Dr Alireza Khadem

Regulatory Systems Strengthening

Regulation of Medicines and Other Health Technologies

Essential Medicines and Health Products

World Health Organization (Geneva, Switzerland)

Office: +41 (0)22 791 2950

Email: rosskopfu@who.int