The AMA Treaty entered into force on 5th November 2022 upon deposit of the 15th instrument of ratification at the African Union Commission (AUC), To date, 22 AU Member States have ratified the Treaty and deposited the instrument at the AUC.
African Medicines Agency
AMRH Technical Committees
Blood and Blood Products Technical Committee(ABRF-TC)
The ABRF is a network of regulators and allied stakeholders operating as a Continental Technical Working Group (CTWG) under the AMRH Initiative, dedicated to cooperation and coordination in blood products regulation across Africa. The ABRF works closely with Regional Economic Communities (RECs) to increase access to quality assured, safe and effective blood products through harmonizing of regulations, strengthening of national regulatory systems and enhancement of international cooperation in this area.
African Vaccine Regulatory Forum Technical Committee (AVAREF-TC)
To strengthen ethics and regulatory capacity for clinical trials ensuring oversight of product development in African countries.
Medical Devices Technical Committee (AMDF-TC)
To study and recommend ways to harmonize medical devices and diagnostics regulation in Africa.
African Medicines Quality Forum Technical Committee (AMQF-TC)
Information Management Systems Technical Committee (IMS-TC)
To provide innovative, quality and sustainable ICT solutions and services that meet the aspiration African Medicines Regulatory Agency in term of communication, collaboration, harmonization, reliance and convergence of medicine regulations in Africa.
Regulatory Capacity Development Technical Committee (RCD-TC)
To provide technical advice to AMRH Steering Committee on human resources development needs to strengthen medicines regulatory capacities and systems in Africa.
Good Manufacturing Practices Technical Committee (GMP-TC)
To lead and spearhead building and strengthening of GMP inspections capabilities to AU Member States in collaboration with RECs, pharmaceutical industry, and partners in attaining acceptable maturing for GMP standards in Africa.
Evaluation of Medicinal Products Technical Committee (EMP-TC)
To play a leading role in the scientific evaluation of human medicinal products at continental level and in harmonizing assessment, registration and marketing authorization activities at REC and NRA levels.
Medicines Policy and Regulatory Reforms (MPRR-TC)
To support AU Member States and RECs efforts to create enabling policy and legal systems for the regulation of medical products
RCOREs
The African Medicines Regulatory Harmonisation (AMRH) Programme aims to contribute to the broader AUDA-NEPAD and AU vision and mission. Of particular focus to AMRH is the African Union Pharmaceutical Manufacturing Plan for Africa (PMPA) endorsed by AU Heads of State in 2005 and the Roadmap for Shared Responsibility and Global Solidarity for the AIDS, TB and Malaria response in Africa, endorsed by AU Heads of State in 2012. Both decisions focus on ensuring the sustainable supply of quality essential medicines to improve public health and promote industrial and economic development on the continent.
AMRH Partnership Platform
To ensure that Africa's medical products regulatory system works effectively, the AMRH works closely with partners and stakeholders. The AMRH Partnership Platform is the Steering Group for the African chapter of the WHO's global Coalition of Interested Parties (CIP), which aims to effectively manage and coordinate different partners and stakeholders involved in this stream of work around the world, to avoid duplication, ensure optimal utilization of resources and establish consensus on priority areas of intervention.