1. Coordinate and strengthen ongoing initiatives to harmonize medical products regulation and enhance the competence of GMP inspectors to do so;
AMA will be established as a Specialized Agency of the African Union (AU) dedicated to improving access to quality, safe and efficacious medical products in Africa by strengthening the capacity of AU countries to regulate medicines and related products, provide regulatory guidance, and harmonise (but not replace) medical regulation efforts across the continent.
1. Coordinate and strengthen ongoing initiatives to harmonize medical products regulation and enhance the competence of GMP inspectors to do so;
2. Coordinate the collection, management, storage and sharing of information on all medical products including SF medical products, with all its States Parties and globally
3. Coordinate joint reviews of applications for the conducting of clinical trials and Provide technical support in quality control of drugs at the request of Member States which do not have the structures to carry out these examination/controls/checks
4. Promote the adoption and harmonization of medical products regulatory policies and standards, as well as scientific guidelines, and coordinate existing regulatory harmonization efforts in the RECs and RHOs;
5. Designate, promote, strengthen, coordinate and monitor RCOREs with a view to developing the capacity of medical products regulatory professionals;
6. Coordinate and collaborate, where required and on a regular basis, the inspection of drug manufacturing sites, including the regulatory oversight and safety monitoring of medical products, as determined by State Parties and/or the AMA, and make reports available to States Parties;
7. Promote cooperation, partnership and recognition of regulatory decisions, in support of regional structures and NMRAs, that takes into account mobilization of financial and technical resources to ensure sustainability of the AMA;
8. Convene, in collaboration with the WHO, the AMRC and other bodies, meetings related to medical products regulation in Africa
9. Provide regulatory guidance, scientific opinions and a common framework for regulatory actions on medical products, as well as priority and emerging issues and pandemics in the event of a public health emergency on the continent with cross border or regional implications where new medical products are to be deployed for investigation and clinical trials;
10. Examine, discuss and/or express regulatory guidance on any regulatory matter within its mandate, either on its own initiative or at the request of the African Union, RECs, or States Parties;
11. Provide guidance on regulation of traditional medical products
12. Provide advice on the marketing authorization application process for the priority drugs described by the States Parties or on the products proposed by the pharmaceutical laboratories;
13. Monitor the medicines market through the collection of samples in every State Party to ensure the quality of selected drugs, have them analysed and provide the results to States Parties and other interested parties, who will thus have reliable information on the quality of the drugs circulating in their countries and, where necessary, will take appropriate measures;
14. Develop systems to monitor, evaluate and assess the comprehensiveness of national medical products regulatory systems with the view to recommend measures that will improve efficiency and effectiveness
15. Evaluate and decide on selected medical products, including complex molecules, for treatment of priority diseases/conditions as determined by the African Union, and WHO
16. Provide technical assistance and resources, where possible, on regulatory matters to States Parties that seek assistance and pool expertise and capacities to strengthen networking for optimal use of the limited resources available
17. Coordinate access to and network the services available in quality control laboratory services within national and regional regulatory authorities; and
18. Promote and advocate for the adoption of the AU Model Law on medical products regulation in States Parties and RECs to facilitate regulatory and legal reforms at continental, regional and national levels.
What is medicines regulation?
Everybody wants to be able to receive medical treatment if they are ill. Therefore medicines that are effective against the illness are needed.
Unfortunately all medicines come with unwanted side effects. Irrespective of this, medicines on the market must be safe for normal use. Medicines must be reliable. This means that they must be manufactured according to high quality standards.
All these points are addressed through regulation. Medicines are regulated to ensure that only sufficiently safe, effective and high quality medicines can be marketed. A regulatory system for medicines should provide timely access to effective treatments for patients, protect patient safety, and foster research into new treatments.
Why are advocating for AMA?
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.
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.
The African Medicines Agency will be the second specialised health agency of the African Union after the Africa Centres for Disease Control and Prevention (Africa CDC) that will enhance capacity of State Parties and AU recognised Regional Economic Communities (RECs) to regulate medical products to improve access to quality, safe and efficacious medicines, medical products and technologies on the continent.
AMA aims to provide support for the improvement of weak regulatory systems. AMA shall build on the efforts of the African Medicines Regulatory Harmonization (AMRH) initiative (2009), which is led by the Africa Union Development Agency - the New Partnership for Africa’s Development (AUDA- NEPAD). The AMRH initiative provides guidance to AU recognised Regional Economic Communities (RECs) and Regional Health Organizations (RHOs), to facilitate harmonisation of regulatory requirements and practice.
AMA will gain a great deal from the African Continental Free Trade Area (AfCFTA) as it allows access of goods and services without tariffs to a market of over 1.2 billion potential consumers. Through this mechanism Africa has created a single continental market for goods and services across the continent as well as accelerated the establishment of a customs union which now leads to the creation of an African Economic Community by 2028. Through the coming into a force of the AfCFTA, Africa becomes the largest integrated trading area in the world. This has huge implications for the pharmaceutical industry and in particular for the movement of goods and services associated with medicines, medical products and technologies. Regulation shall be critical to guaranteeing the protection of the 1.2 billion African market from fake, substandard, and counterfeit products and services.
The AMA Treaty was adopted by Heads of States and Government during their 32nd Ordinary Session of the Assembly on 11 February 2019 in Addis Ababa, Ethiopia Assembly/AU/Dec.735 (XXXII). The Treaty establishing the African Medicines Agency (AMA) entered into Force on 5th November 2021, following the deposit of the 15th instrument of ratification, on the 5th of October 2021, by the Republic of Cameroon at the African Union Commission (Article 38; AMA Treaty).
African Union’s Pharmaceutical Manufacturing Plan for Africa (PMPA) was established to develop the African pharmaceutical industry (Assembly/ AU/Dec.55(IV), a sector with considerable potential for reducing the burden of disease in Africa. With a projected value of over US$40 billion by the next decade, the sector will also contribute significantly to economic growth. A business plan for implementing the plan was developed and considerable progress has been recorded including the establishment of initiatives to harmonise medicine regulation on the continent [Assembly/AU/DEC413(XVIII)], addressing human capacity and skills shortages, and promoting cooperation and advocacy in the industry. The optimism in the sector has also galvanised countries and regions with manufacturing capacity to harness support for the development of the sector despite the funding challenges.