1 of 10

WHO role in regulatory system strengthening, convergence and reliance

Marie Valentin

Technical Officer,

Regulatory Convergence and Networks Team

Regulation and Safety Unit, Regulation and Prequalification Department,

World Health Organization

1

10th Global Patients Congress

Emphasizing the critical need for patient partnerships in medicines and health devices regulation

WHO / Fatoumata Diabate

2 of 10

Medical products – instrument for public heath

2

​

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

​

3 of 10

Access to medical products – global challenge

  • Good health is impossible without access to medical products;
  • An estimated two billion people have no access to essential medicines, effectively shutting them off from the benefits of advances in modern science and medicine.
  • Reasons for limited/insufficient access are numerous – including insufficient/inadequate regulatory capacity and lack of collaboration and work sharing between countries in regulation of medical products.

3

4 of 10

Capacity to regulate medical products globally

Strong regulatory capacity is an essential component of a well-functioning healthcare system (Resolution WHA 67.20, 2014)

4

  • Globally, >70% of countries have weak national regulatory systems:
      • Only 57 countries (29%) have regulatory systems at GBT maturity level 3 or 4 (https://www.who.int/initiatives/who-listed-authority-reg-authorities):
        • Lack of skilled personnel;
        • Lack of appropriate technology;
        • Lack of regulatory tools and guidelines;
        • Lack of requirements that are publicly available.

​

March 2023

5 of 10

Objectives of the WHO regulatory system strengthening programme

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

Good regulatory practices, 2021

Good reliance practices, 2021

Why reliance?

6 of 10

Reliance during COVID-19 pandemic response

6

For example, first WHO EUL for a COVID-19 vaccine (BNT162b2 mRNA vaccine) 31 December 2020, ten days after European Medicine Agency scientific opinion (NRA of reference)

Expert Review of Clinical Pharmacology

https://www.tandfonline.com/doi/full/10.1080/17512433.2022.2088503

For example, first roll-out in Feb-March 2021 ChAdOx1 vaccine, approvals/import permits in 101 countries out of 145 (70%) within 15 days of WHO EUL (15 February 2021)

​

Reliance was key to facilitate access to COVID-19 vaccines

Reliance used for all regulatory functions

WHO EUL as reference to facilitate in-country authorization for use

WHO Emergency Use Listing (EUL) based NRA of reference

Authorization, pharmacovigilance,

batch release, post-authorization changes (e.g. new manufacturing sites, shelf-life extension, paediatric indications, etc.)

​

7 of 10

Regulatory convergence and harmonization initiatives

Convergence and harmonization efforts should in theory diminish duplication, creating a "common language" for decision-making and facilitating cooperation, work-sharing and eventually reliance or recognition

African Medicines Regulatory Harmonization Initiative (AMRH)

PANDRH

African Vaccine Regulators Forum (AVAREF)

ASEAN SIAHR Project

8 of 10

Reliance and harmonization - win-win outcomes for all concerned stakeholders - patients in the focus

Patients

NRAs

WHO, procurers, donors…

Manufacturers

©www.clipartkey.com

Facilitate access to quality-assured medical products

Speed-up approval timelines

Efficient use of available resources, avoid duplication

Better submission management for global supply

9 of 10

International Conference of Drug Regulatory Authorities (ICDRA)

  • The ICDRA conferences have been held biannually since 1980 with the aim of promoting exchange of regulatory information on medical products and collaborative approaches to issues of common concern;
  • ICDRA is a platform established to develop international consensus on regulatory matters;
  • After 40 years of existence ICDRA continues to be an important tool for WHO and medicines regulatory authorities in their efforts to harmonize regulation and improve the safety, efficacy and quality of medicines.

Next ICDRA in June 2024 New Delhi, India (dates to be confirmed)

  • to promote collaboration between national medicines regulatory authorities.
  • to reach a consensus on the matters of common interest.
  • to facilitate timely and adequate exchange of information.
  • to discuss issues of international relevance.

https://www.who.int/teams/regulation-prequalification/regulation-and-safety/regulatory-convergence-networks/icdra

​

10 of 10

www.who.int/medicines

10

Thank you for your attention!

Marie Valentin, Technical Officer, Regulatory Convergence and Networks Team, World Health Organization

valentinm@who.int