Press release 5 February 2021

Patients, product development partnerships and private health sector representatives call for the rapid ratification of the African Medicines Agency Treaty to speed up timelines to vaccines and medicines approval


On the eve of the 34th African Union Summit, two years after the Treaty to establish an African Medicines Agency was agreed, over 40 leading organizations who represent hundreds of thousands of patients, product development partnerships, youth groups, researchers and industry leaders, are urging Heads of State and Government to ratify the Treaty as a matter of priority. Delaying the establishment of an African Medicines Agency (AMA) undermines the timely access to effective, quality therapies, and vaccines for all patients across Africa.

The COVID-19 pandemic has highlighted the importance of regulatory harmonisation in the context of public health emergencies and the urgent need for a competent continent-wide regulatory authority to approve and monitor vaccines, repurposed medicines, innovative medicines and health technologies, in a timely manner.

Two years after African Union Heads of State and Government endorsed the treaty establishing the AMA, legal commitment from more countries remains to be secured for the continent-wide regulatory agency to become a reality. The Treaty has so far been signed by 19 countries, and 8 out of the necessary 15 have already ratified it.

The agency would follow a similar mandate to other global medicines regulatory agencies, such as the European Medicines Agency and the U.S. Food and Drug Administration. The AMA would provide an enabling environment for research and development, country participation in clinical research and other scientific development activities, as well as open more opportunities to boost local manufacturing capacities. Furthermore, the AMA would help effectively manage the prevalence of substandard and falsified medical products, currently inflicting severe pain and harm on patient’s lives, due to porous borders and ineffective regulatory control.

The African Medicines Agency is the cornerstone of establishing a sustainable public health system in Africa”, says Kawaldip Sehmi, CEO of the International Alliance of Patients Organizations (IAPO). “A number of leading countries have signed the treaty and close to half of them have so far transposed it into national law. Paradoxically, the ratification process has sometimes been delayed with attention shifting towards the COVID-19 response. That is precisely what the AMA’s mission will be: to help African countries fight disease outbreaks by ensuring that only high-quality drugs, vaccines, and other health-related supplies reach the market and health systems from Cape to Cairo”.

“There have been positive moves towards regulatory harmonization in Africa. However, the establishment of the African Medicines Agency is a critical next step to enable all patients in Africa to have timely access to quality medicines that are safe and effective”, added Adam Aspinall, chair of the Fight the Fakes Alliance.

Regulatory systems strengthening and harmonization efforts are key for optimizing sustainability in the supply and access of medical products and technologies for diseases disproportionately affecting Africa”, said Karim Bendhaou, Head of Africa Affairs, Merck and IFPMA Chair, Africa Engagement Committee.

The following organizations support this call (in alphabetical order):

  1. Action Group for Health, Human Rights and HIV and AIDS – AGHA
  2. African Heart Network
  3. African Liver Patients Association
  4. African Research Network for NTDs –ARNTD
  5. Association of Representatives of Ethical Pharmaceutical Industries – AREPI
  6. Association pour last Lutte contre les Hépatites Virales “ALHV”
  7. Centre for Initiative and Development – CFID Taraba
  8. Coalition for Access to NCD Medicines and Products
  9. Drugs for Neglected Diseases initiative – DNDi
  10. Federation of African Pharmaceutical Manufacturers Associations – FAPMA
  11. Fight the Fakes Alliance
  12. Generic and Biosimilar Medicines of Southern Africa
  13. German Medical Aid Organization action medeor V
  14. Global Pharma Health Fund
  15. Global Self-Care Federation
  16. GS1
  17. Heart and Stroke Foundation South Africa
  18. Hepatitis Foundation of Ghana
  19. International Alliance of Patients’ Organizations – IAPO
  20. International Federation of Pharmaceutical Manufacturers and Associations – IFPMA
  21. Innovative Pharmaceutical Association South Africa – IPASA
  22. International Pharmaceutical Students’ Federation – IPSF
  23. Kenya Association of the Pharmaceutical Industry- KAPI
  24. Kenya Healthcare Federation
  25. Les entreprises du medicament -LEEM
  26. LiveWell Initiative – LWI
  27. Management Sciences for Health
  28. Medical Mission Institute Würzburg
  29. Mental Health Society of Ghana – MEHSOG
  30. Multiple Sclerosis South Africa
  31. National Community of Women Living with HIV in Uganda – NACWOLA
  32. NCD Alliance Ghana
  33. NCD Alliance Kenya
  34. Pan African Positive Women’s Coalition
  35. PATH
  36. Patient and Community Welfare Foundation of Malawi – PAWEM
  37. Pharmaceutical Society of Kenya
  38. RTI International -Center for Global Noncommunicable Diseases
  39. Sharecare Ghana
  40. South African NCDs Alliance
  41. Speak Up Africa
  42. Stowelink Inc.
  43. Thalassaemia International Federation
  44. Uganda Alliance of Patient Organisations
  45. Women in Hepatitis Africa
  46. World Heart Federation



The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) represents over 90 innovative pharmaceutical companies and associations around the world. Our industry’s almost three million employees discover, develop, and deliver medicines and vaccines that advance global health. Based in Geneva, IFPMA has official relations with the United Nations and contributes industry expertise to help the global health community improve the lives of people everywhere. For more information, visit

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Media Contact

Elliot Dunster