On 26 January 2024, the European Medicines Agency (EMA) announced that it has received a €10 million grant from the European Commission to support regulatory systems in Africa, and in particular for the setting up of the African Medicines Agency (AMA). Although still in its early stages as an agency, AMA shows significant promise to harmonize the regulatory landscape across the continent in order to improve access to quality, safe and efficacious medical products in Africa. Other key organizations who are working to establish and implement the vision set out for AMA include the African Union (AU), comprising of 55 member states in Africa, the African Union Development Agency (AUDA-NEPAD) and the World Health Organization (WHO). Of importance, AMA is expected to play an important role in facilitating intra-regional trade for pharmaceuticals in the context of the Africa Continental Free Trade Area (AfCFTA).
Background to AMA and medicines regulation in Africa
Africa currently has limited harmonization of medicines regulation between jurisdictions. The functionality and regulatory capacity of national medicines regulatory authorities varies significantly. For example, many national regulators lack the technical expertise to independently assess innovative marketing authorization applications and instead adopt “reliance” procedures, whereby authorization by a foreign stringent regulatory authority or registration as a WHO pre-qualified product may be a condition for approval. Pharmaceutical manufacturers seeking to conduct multinational clinical trials or launch their products across Africa can often face challenges when navigating the divergent requirements for each country (and can face additional delays during each approval process).
Multiple initiatives in the last decade have aimed to increase the harmonization of medicines regulation across Africa with varying degrees of success, such as:
- the AU’s Model Law on Medical Products Regulation;
- the East African Community Medicines Regulatory Guidelines;
- the Southern African Development Community Medicines Regulatory Harmonization (SADC-MRH) initiative (through the “ZAZIBONA” Collaborative Procedure for Medicines Registration); and
- most importantly, AMA.
In February 2019, the AU adopted the treaty for the establishment of AMA (AMA Treaty). AMA will function as a Specialized Agency of the AU. In its press release, the AU confirmed that AMA “will serve as the continental regulatory body that will provide regulatory leadership, to ensure that there are harmonized and strengthened regulatory systems, which govern the regulation of medicines and medical products on the African continent.” AMA will have six main functions:
- evaluating selected medicines for treatment of priority diseases, as decided by the AU;
- coordinating the inspection of manufacturing sites and providing regular information regarding products for marketing;
- coordinating the information released regarding the medicinal products;
- collecting and storing information regarding the quality and safety of the selected products, sharing this information globally and collaborating with global and regional centers for safety monitoring;
- coordinating joint reviews of applications for clinical trials; and
- coordinating quality control laboratory services on behalf of national and regional regulatory authorities.
Current Status of AMA
The AMA Treaty entered into force on 5 November 2021 (after the Republic of Cameroon became the 15th country to ratify the treaty) and Rwanda was selected to host the AMA headquarters in 2022. To date, 27 countries have ratified the AMA Treaty, with more countries expected to do the same in 2024. AMA is also in the process of appointing its leadership team, which will include a director general to lead its efforts both in terms of operationalizing AMA and setting out its strategic plans for the future.
However, at this time, AMA is still in its nascent stage. AMA is yet to issue any regulatory guidelines or procedures.
Future Collaboration between the EMA and AMA
As part of the €10 million funding, the EMA aims to collaborate with African, European and international parties to progress AMA into a functioning agency. This support will include scientific and regulatory training to enable AMA to effectively evaluate and supervise medicines across the region. The EMA’s support forms part of the European Commission’s wider “Team Europe” initiative on manufacturing and access to vaccines, medicines and health technologies in Africa, which to date has deployed €1.3 billion in support.
We can only assume that the EMA will be able to share valuable learnings on the complex topic of implementing a multinational medicines regulatory authority. While much of the detail regarding how AMA will function in practice is yet to be clarified, its potential to transform the provision of medicines for a population of over 1.4 billion people is groundbreaking on a global scale.
If you have any queries concerning life sciences regulatory matters in Africa or any of the material discussed above, please contact the members of Covington’s Life Sciences in Africa practice group.