n February 15, 2022, the European Union (EU) announced that Team Europe—the European Commission, the European Medicines Agency (EMA), and EU Member States Belgium, France, and Germany—and the Bill & Melinda Gates Foundation will mobilize more than €100 million over the next five years to support the recently established African Medicines Agency (AMA) and other African medicines regulatory initiatives at regional and national levels.

This mobilization will support the first stages of the continent-wide AMA and the further development of African medicines regulatory capacity at regional and national levels. This initiative aims to foster collaboration and sharing of technical expertise by European regulators with AMA and support African national regulatory authorities (NRAs) to achieve the minimum World Health Organization (WHO) requirements for effective regulatory oversight of quality-assured, safe, local production of medicines and vaccines.

Since its creation, EMA has been committed to protecting public health in Europe and beyond. EMA supports access to safe, effective, high-quality medicines for patients on the African continent through multiple collaborations at national, regional, and now continental levels.

EMA, in cooperation with WHO, can provide scientific opinions on high-priority human medicines, including vaccines, generics, and biosimilars, which are intended for markets outside of the EU. The procedure is called EU-Medicines for all (EU-M4all).

EU-M4all combines EMA’s scientific review capabilities with epidemiology and disease expertise from WHO experts and national regulators in the countries where the products are expected to be used. Regulators, experts, and observers from low- and middle-income countries are invited to participate actively in scientific review, ensuring that EMA considers specific disease expertise and local knowledge in its decision-making process, while NRAs gain in-process experience in assessing medicines and vaccines of major public health interest.

Throughout, in collaboration with WHO and relevant non-EU authorities, EMA experts execute robust scientific evaluation with the same high standards applied to medicines approved in the EU.

Additionally, because WHO and target country experts and regulators are invited to be part of both product development (through scientific advice) and assessment (through scientific opinion), faster prequalification, registration, and access to vaccines and medicines can be achieved at the national or regional levels.

To date, 14 positive scientific opinions have been delivered through the EU-M4all procedure, including two products in April 2022. Based on these EU-M4all scientific opinions, 138 approvals have been granted in 90 countries outside of the EU.

Additionally, since regulatory approval is being sought both within and outside the EU for many innovative medicines, applicants can apply in parallel to the centralized procedure and EU-M4all.

EMA also supports the WHO collaborative registration procedure for centrally authorized products and for products with EU-M4all positive scientific opinions. Medicine registration can take a significant amount of time for authorities with limited regulatory resources and become one of the main barriers to patient access in their jurisdictions. Consequently, EMA works with WHO to promote reliance, to facilitate assessment and registration of therapeutics and vaccines already assessed in the EU, leading to faster patient access. Reliance avoids duplication of effort to allow better use of often limited regulatory resources on regulatory processes that add value, while also contributing to regulatory capacity building and harmonization.

Through this collaborative registration procedure, marketing authorization or EU-M4all scientific opinion holders share the EMA full assessment report, manufacturing site(s) inspection reports (including confidential information necessary for the evaluation), and the Quality Information Summary with NRAs in line with the EU dossier. NRAs can then decide to rely either fully or partially on the EMA’s evaluation while at the same time remain independent, responsible, and accountable for the approval decisions in their countries.

COVID-19 Challenges and Collaborations

The COVID-19 pandemic challenged regulatory authorities’ resilience worldwide, and international collaboration was key to ensuring a robust and effective global response. To support rapid and aligned decision making, EMA launched the OPEN pilot, where regulators from Australia, Canada, Japan, Switzerland, and the WHO participated in the assessment of COVID-19 vaccines and therapeutics under the terms of existing confidentiality arrangements. The OPEN pilot facilitated assessment of the same data by multiple authorities. It also allowed regulators to accelerate and align on decisions, leading to fewer labeling differences, while maintaining independence in the decision making. In addition, the collaboration within OPEN enabled the WHO Prequalification Team to use the EMA COVID-19 medicines assessments for the WHO Emergency Use Listing (EUL) of vaccines and for the prequalification of therapeutics. With this EMA-WHO cooperation, the OPEN initiative contributed to breaking down regulatory barriers and facilitating equitable access to COVID-19 vaccines and therapeutics.

Cooperation and Collaboration

Cooperation and collaboration are in the DNA of the European medicines regulatory system, which brings together regulatory authorities from each EU Member State, the European Commission, and EMA itself. Whether working at the European or international levels, this approach allows the EU network to:

• Pool resources and coordinate work to regulate medicines efficiently and effectively
• Create certainty for patients, healthcare professionals, industry, and governments by ensuring consistent standards and use of the best available expertise
• Reduce administrative burden and allow medicines to reach patients faster
• Accelerate the exchange of information on important issues such as medicine safety.

A model for cooperation among medicine regulators will be key to effectively supervise complex supply chains, avoid duplication of regulatory work, align regulatory approaches, and make the best use of resources in Africa.

In addition to supporting regulatory systems strengthening and the registration of medicines, the EU network can possibly serve as inspiration for regulators in Africa to foster collaboration between countries and regions. EMA stands ready to continue its support to our counterparts in Africa, especially as they work to make AMA a reality.