The African Medicines Regulatory Harmonisation initiative (AMRH) and its work spanning over thirteen years across five African Union regional economic communities (RECs), lays a solid and firm foundation for the establishment of the African Medicines Agency (AMA). The Agency, which is a specialised AU agency, is responsible for delivering strengthened and robust regulatory systems across Africa.

The AMRH aims to ensure that all Africans can access good quality medical products that are not only safe, but also effective and affordable. This is done through strengthening medical products regulation and also facilitating the harmonisation of AU member states’ regulatory processes, standards and norms.

The Pharmaceutical Manufacturing Plan for Africa (PMPA), which underpins the work of AMRH, envisions an Africa where there is significantly less reliance on pharmaceutical imports and reduced proliferation of sub-standard and falsified medicines on the continent. COVID-19 worsened the situation in Africa since the pandemic emerged in February 2020. All AU members states were affected and new variants and new waves of the virus continued to increase the demand on health care, as countries tried to keep up with procuring and distributing vaccines and other essential medical products. Because of this, the need for countries to manage their regulatory systems effectively and efficiently also grew, as did the reality that for Africans to equitably access medical products especially in times of emergency, local production efforts need to be intensified.

Unfortunately, most African National Medicines Regulatory Authorities (NMRAs) were not as ready to manage the need for a heightened regulatory response either due to incoherent medicines regulatory polices to handle public health emergencies or other critical challenges such as a lack of sufficient human resources and funding. The AMRH enhanced efforts to ensure the domestication of the AU Model Law on Medical Products Regulation as well as provided technical support to member states to effectively regulate medical products.

AMA is the vehicle Africa needs to take it to the next level of economic development and equitable access to health products. The good news is that much progress has been made so far - twenty three countries have ratified the AMA Treaty, with more coming on board soon, and Rwanda is officially home to AMA with the host agreement having been signed on 10 June 2023.

Most recently, the AUC, in collaboration with the Government of the ‎Republic of Rwanda, convened the Second Extraordinary ‎Session of the Conference of States Parties (CoSP) to ‎the AMA ‎Treaty from 19-20 June 2023 ‎in Kigali, Rwanda. The meeting, which AUDA-NEPAD was a part of, made critical progress on the steps towards recruitment of the AMA Director General and establishment of the AMA Governing Board. The board will oversee AMA to ensure that it provides excellent scientific opinion and guidance to AU member states.

AUDA-NEPAD through a dedicated task team, will continue to support the AUC in terms of the technical aspects to AMA’s operationalisation and a 5 year robust work plan was developed by AUDA-NEPAD in 2022 to fast track this support.

A few ways that Africa will benefit from AMA:

• AMA will address the current fragmentation in regulatory systems which we have seen to be a significant cause of delays of approval and authorisation to market medical products.
• AMA will enable research and development of our own medical products and vaccines, which is critical to handling future public health emergencies. The loss to human life and the impact on the economy will be significantly less if we streamline and strengthen our regulatory policies and processes and continue in the spirit of work sharing and collaboration under a dedicated, sustainable legal structure.
• AMA will also strengthen the capacity of RECs and NMRAs to share important regulatory information thereby helping to mitigate issues such as the illegal entrance of sub-standard and falsified medicines into African markets.
• As local manufacturing increases, it is envisaged that trade will inevitably increase, and this will in turn support Africa as it also heads towards implementation of the Africa Continental Free Trade Area(AfCFTA) which has the potential to lift over 30 million Africans out of poverty.

The remaining countries which are still to join AMA are encouraged to not be left behind. The benefits of AMA will be fully realised once every country is on board. COVID-19, Ebola and any future pandemics can only be tackled in unity. Africa must rally behind the AMA Treaty to ensure all countries can take part in competitive local manufacturing of our own quality products, and to contribute to rising economies and access to medical products for all citizens.