Nairobi: Africa is counting on the Africa Medicines Agency (AMA) to drive regulatory harmonisation in the medical sector, spur local manufacturing, and reduce dependence on imported health products to strengthen the continent’s preparedness and response to public health emergencies. Speaking in Mombasa during the 7th Biennial Scientific Conference on Medical Products Regulation in Africa (SCoMRA), the Chairman of the Pharmacy and Poisons Board, Dr John Munyu, discussed the challenges and opportunities facing the continent in the medical sector.
According to Kenya News Agency, Dr Munyu highlighted that Africa imports over 90 per cent of its medicines, with less than one per cent of vaccines produced locally, a vulnerability exposed during the COVID-19 pandemic. The conference, themed ‘Regulatory Harmonisation: Unlocking Africa’s Potential in Health Product Manufacturing and Trade’, aims to enhance regulatory oversight to attract and sustain local manufacturing investments.
Dr Munyu reaffirmed Kenya’s commitment to harmonising regulatory frameworks and noted that medical officers have been deployed to spearhead the country’s efforts. He praised the African Medicines Regulatory Harmonisation (AMRH) for its instrumental role over the past decade in building a robust regulatory system from the national to the regional level, which is now transitioning to the AMA.
Significant strides have been made, including the harmonisation of regulatory guidelines across Regional Economic Communities and the digitalisation of regulatory processes. ‘This foundation has paved the way for a historic leap forward: the operationalisation of the African Medicines Agency (AMA), headquartered in Kigali,’ Dr Munyu stated.
Dr Munyu described the AMA as the embodiment of a shared African vision for a self-reliant, resilient continent capable of safeguarding the health of its people. He emphasized the AMA’s role in catalysing local manufacturing, facilitating intra-African trade under the AfCFTA, and ensuring that quality, safe, and efficacious medical products reach every African in need.
AMA Director General Dr Delese Darko explained that the agency was established by an African Union treaty. She noted that the AMA offers a unified regulatory process similar to the European Medicines Agency, which aims to expedite the availability of medicines across Africa.
Dr Darko recalled challenges during the Coronavirus pandemic, highlighting that AMA will allow faster access to essential medicines in the future. She also mentioned the agency’s role in coordinating the manufacture of complex medical products in Africa, ensuring the continent’s capacity to tackle various health challenges.
To fully realise this vision, African Union member states are urged to sign the AMA treaty, as only 31 member states have done so, with 24 remaining. Dr Darko appealed for a unified Africa, where all 55 member states can collaborate on regulatory decisions.
The Director of Human Capital Development at the African Union Development Agency, Symerre, underscored the importance of the conference in making local manufacturing and intra-African trade in medical products a reality. He stressed the necessity of a robust continental supranational agency to transform Africa into a manufacturer and exporter of medical products.
