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:

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:

  1. evaluating selected medicines for treatment of priority diseases, as decided by the AU;
  2. coordinating the inspection of manufacturing sites and providing regular information regarding products for marketing;
  3. coordinating the information released regarding the medicinal products;
  4. 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;
  5. coordinating joint reviews of applications for clinical trials; and
  6. 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.

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Photo of Grant Castle Grant Castle

Grant Castle is a partner in London and Dublin practicing in the areas of EU, UK and Irish life sciences regulatory law. He supports innovative pharmaceutical, biotech, medical device and diagnostics manufacturers on regulatory, compliance, legislative, policy, market access and public law litigation…

Grant Castle is a partner in London and Dublin practicing in the areas of EU, UK and Irish life sciences regulatory law. He supports innovative pharmaceutical, biotech, medical device and diagnostics manufacturers on regulatory, compliance, legislative, policy, market access and public law litigation matters in the EU, UK, and Irish Courts.

He is one of the Co-chairs of Covington’s Life Sciences Industry Group and is Head of Covington’s European Life Sciences Regulatory Practice.

Grant regularly advises on:

  • EU and UK regulatory pathways to market for pharmaceuticals and medical devices, including in vitro diagnostics and on associated product life cycle management;
  • Pharmaceutical GxPs, including those governing pharmacovigilance, manufacturing, the supply chain and both clinical and non-clinical research;
  • Medical device CE and UKCA marking, quality systems, device vigilance and rules governing clinical investigations and performance evaluations of medical devices and in vitro diagnostics;
  • Advertising and promotion of both pharmaceuticals and medical devices; and
  • Pricing, reimbursement and market access for both pharmaceuticals and medical devices.

Grant also handles procedural matters before EU, UK and Irish regulators and UK and Irish market access bodies, where necessary bringing judicial reviews for his life sciences clients before the EU, UK and Irish Courts.

Chambers UK has ranked Grant in Band 1 for Life Sciences Regulatory for the last 18 years. He is recognized by Chambers UK, Life Sciences as “excellent,” “a knowledgeable lawyer with a strong presence in the industry,” who provides “absolutely first-rate regulatory advice,” according to sources, who also describe him as “one of the key players in that area,” whilst Chambers Global sources report that “he worked in the sector for many years, and has a thorough understanding of how the industry ticks.” He is praised by clients for his “absolutely first-rate” European regulatory practice. Legal 500 UK notes that he is “highly competent in understanding legal and technical biological issues.”

Photo of Mosa Mkhize Mosa Mkhize

Mosa Mkhize is a policy advisor in the firm’s Africa Practice Group through which she provides strategic policy and regulatory advice to clients doing business with and across Africa.

Ms. Mkhize, a non-lawyer, has over a decade of experience in international trade and…

Mosa Mkhize is a policy advisor in the firm’s Africa Practice Group through which she provides strategic policy and regulatory advice to clients doing business with and across Africa.

Ms. Mkhize, a non-lawyer, has over a decade of experience in international trade and public policy. During this time, she has supported senior policymakers and private sector companies on a broad range of issues including policymaking and development, negotiating complex international trade deals, and advocating for policies and regulations related to science and technology. In addition to this, Ms. Mkhize’s capabilities include building strategic relationships and coalitions in support of smart technologies. Furthermore, she is currently working with government officials, private corporations, academia, and the general public on facilitating policies in the smart technology space.

Photo of Roderick Dirkzwager Roderick Dirkzwager

Roderick Dirkzwager advises clients in the life sciences sector on a broad range of regulatory, transactional and intellectual property matters relating to the discovery, development and commercialization of their products.

Roderick is a member of Covington’s Diversity and Inclusion Committee and is a…

Roderick Dirkzwager advises clients in the life sciences sector on a broad range of regulatory, transactional and intellectual property matters relating to the discovery, development and commercialization of their products.

Roderick is a member of Covington’s Diversity and Inclusion Committee and is a co-lead of the LGBT+ Affinity Group in London.

With a broad life sciences practice, Roderick regularly advises on:

  • EU, Irish, and UK regulatory issues relating to pharmaceutical products, medical devices and consumer products;
  • commercial agreements that span the product life-cycle in the life sciences sector, including collaborations and other strategic agreements, clinical trial agreements, distribution arrangements and manufacturing and supply contracts;
  • regulatory and commercial due diligence for life sciences transactions; and
  • intellectual property issues arising in corporate transactions and IP-related contracts.

Prior to joining the firm, Roderick completed his Ph.D. in Biochemistry, focusing on the development of novel, low-cost malaria diagnostic technologies using DNA aptamers.