Call to Heads of State of the African Union to Ratify the African Medicines Agency Treaty

Call to Heads of State of the African Union to Ratify the African Medicines Agency Treaty

Thursday, 4 February 2021
Endorse and sign the call    Patients, Civil Society and Youth Organisations, Products Development Partnerships, Health and Pharmaceutical Industries, and all stakeholders who are striving to improve global public health - welcome the African Medicines Agency (AMA) Treaty made at the 32nd ordinary session of the Assembly of the African Union (AU) in 2019. We now call for all AU Member States to ratify the Treaty, which has already been signed by 19 countries and ratified by 8 countries. This is a strong commitment from AU Member States and we therefore urge all countries of the AU to ratify the Treaty as a matter of priority. 


We believe it is critical to establish a continental regulatory body to reduce the complexity of regulatory frameworks and hence to enable all patients in Africa to have timely access to quality medicines that are safe and effective. This new agency is an integral part of the WHO Global Patient Safety Plan 2020-2030. We support the WHO African Region commitment towards the African Medicines Agency delivered by the Kenyan government at the WHO Executive Board in January 2021.

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

Furthermore, a strong unified regulatory system would greatly contribute to combating falsified and substandard medicinal products on the African continent. Coordinated market surveillance, centralised information collection and sharing of data between countries is expected to complement and strengthen national efforts to reduce the circulation of falsified products and increase access to safe and innovative products.

The establishment of the African Medicines Agency will open-up more opportunities to boost local manufacturing capacities, country participation in clinical research and other scientific development activities. 

Considering this, we call for:

1. AU Member States to ratify the AMA Treaty and enable the operational implementation of the continental regulatory system that will benefit patients, regulators, and healthcare systems in Africa. 


2. The African Medicines Agency Governing Board to draw upon all available expertise from academia, research bodies, private sector and community and patient groups to provide technical guidance on specific areas of regulatory expertise.


3. The African Medicines Agency Governing Board to recognise patients as key partners in the management structures and development of the future Agency.


The following organizations support this call.

                                                                      List of Supporters (in alphabetical order): 

Action Group for Health, Human Rights and HIV and AIDS – AGHA

 African Heart Network

African Liver Patients Association

African Pharmaceutical Distribution Association - APDA

African Research Network for NTDs –ARNTD

 Association of Representatives of Ethical Pharmaceutical Industries - AREPI

Association pour last Lutte contre les Hépatites Virales "ALHV"

Centre for Initiative and Development - CFID Taraba

Coalition for Access to NCD Medicines and Products

Drugs for Neglected Diseases initiative – DNDi

Epilepsy South Africa

Federation of African Pharmaceutical Manufacturers Associations - FAPMA

Fight the Fakes Alliance

Global Alliance of Sickle Cell Disease Organisations - GASCDO 

Generic and Biosimilar Medicines of Southern Africa

German Medical Aid Organization action medeor e.V

Global Pharma Health Fund

Global Self-Care Federation


Heart and Stroke Foundation South Africa

Hepatitis Foundation of Ghana

International Alliance of Patients’ Organizations - IAPO

International Federation of Pharmaceutical Manufacturers and Associations - IFPMA

International Federation of Pharmaceutical Wholesalers’ - IFPW

Innovative Pharmaceutical Association South Africa – IPASA

International Pharmaceutical Students’ Federation - IPSF

Kenya Association of the Pharmaceutical Industry- KAPI

Kenya Healthcare Federation

Les entreprises du medicament -LEEM

LiveWell Initiative - LWI

Lupus and Allied Diseases Association, Inc.

Management Sciences for Health

Medical Mission Institute Würzburg

Mental Health Society of Ghana – MEHSOG

Multiple Sclerosis South Africa

National Community of Women Living with HIV in Uganda – NACWOLA

NCD Alliance Ghana

NCD Alliance Kenya

Non-communicable Diseases and Development Initiative

Pan African Positive Women's Coalition


Patient and Community Welfare Foundation of Malawi - PAWEM

Pharmaceutical Society of Kenya

Powerful Patient Inc


RTI International -Center for Global Noncommunicable Diseases

Sharecare Ghana

South African NCDs Alliance

Speak Up Africa

Stowelink Inc.

Thalassaemia International Federation

Uganda Alliance of Patient Organisations

Women in Hepatitis Africa

World Heart Federation

World Hepatitis Alliance





Press Release - Call to Ratify AMA Treaty


The Statement  - English


The Statement  - French       


 African Medicines Agency Q&A   


Endorse and sign the call 


List of supporters last upated on 11 March 2021