PAHWP Addresses Regulation of Medical Devices and Diagnostics to Protect Public Health in Africa

Pan African Harmonization Working Party (PAHWP) Addresses Regulation of Medical Devices and Diagnostics to Protect Public Health in Africa

Regulatory Forum Participants, Nairobi, July 2013

A new generation of point-of-care (POC) diagnostic tests are currently being developed that could save lives and stop the spread of infectious diseases. Access to new tests in Africa can be delayed, sometimes for years, due to complex and costly requirements for regulatory approval in some countries. Costs incurred by the test manufacturers are subsequently passed on to patients – increasing the price of the goods and ultimately limiting access to life-saving tests. Regulatory harmonisation ensures quality-assured, safe medical devices and diagnostics are available and accessible to patients without delay.

To achieve such goals, the Pan African Harmonization Working Party (PAHWP) studies and recommends ways to harmonise regulations related to medical devices and diagnostics in Africa.
PAHWP activities are focused on five harmonisation areas:

  1. Developing a common registry for in vitro diagnostic (IVD) medical devices – using POC tests for CD4, viral load and early infant diagnosis of HIV as examples.
  2. Reducing duplication, costs and delays associated with regulatory audits of manufacturers’ quality management systems.
  3. Reducing duplication of clinical trials for regulatory approval in African countries.
  4. Providing safe, reliable diagnostic products across Africa through post-market surveillance.
  5. Standardising rules for classifying IVD for their regulation based on risk to individual and public health.

PAHWP is a voluntary body conceived in 2012 that was formally announced during the African Society for Laboratory Medicine (ASLM) international conference in Cape Town, South Africa.

Notable achievements to date include:

  • A base line survey of regulation of medical devices and medical diagnostics in East African Community (EAC) Partner States was undertaken in October 2012.
  • The EAC Regional Task Force on Regulation of Medical Devices and Diagnostics meeting held in April 2013 in Dar es Salaam, Tanzania, approved the proposed structure of PAHWP which was presented at the 1st African Regulatory Forum on Medical Diagnostics in July 2013.
  • Convened the 1st African Regulatory Forum on Medical Diagnostics held 24-26th July 2013, Nairobi, Kenya, attended by over 90 people from 21 countries, including stakeholders from National Regulatory Authorities, IVD manufacturers, laboratory based organisations, NGOs and international organisations.

PAHWP is housed in the African Union-New Partnership for Africa’s Development (AU-NEPAD) Planning and Coordinating Agency, under the auspices of the African Regulatory Harmonization Advisory Committee for Medicines, Medical Devices and Diagnostics.
Founding members include:

  • East African Community Health Secretariat (EAC) and the EAC Partner States of Burundi, Kenya, Rwanda, Tanzania and Uganda
  • Ethiopia: Food, Medicine and Health Care Administration and Control Agency (FMHACA)
  • Nigeria: National Agency for Food and Drug Administration and Control (NAFDAC)
  • South Africa: National Health Laboratory Service (NHLS)

PAHWP works in coordination with the: African Society for Laboratory Medicine; Asian Harmonization Working Party (AHWP); German Society for International Cooperation (EAC-GIZ); Latin America IVD Association (ALADDIV); London School of Hygiene & Tropical Medicine (LSHTM); and World Health Organization Regional Office for Africa (WHO AFRO).

PAHWP is facilitated by the London School of Hygiene & Tropical Medicine (LSHTM), with grant funding from Grand Challenges Canada (GCC).