Renewed call for unified framework as pharma regulatory forum opens in Maputo

Maputo, Mozambique — The quest to build a unified and robust regulatory system for pharmaceuticals and medical devices on the continent took the spotlight on Wednesday, October 30, as the 4th African Medicines Regulatory Harmonisation (AMRH) Week officially opened in Maputo. The biennial conference, which began on October 28 with technical committee meetings, is organised by the African Union Development Agency (AUDA-NEPAD) in collaboration with the World Health Organization (WHO). This year’s event is themed ‘15 years of AMRH as a foundation for AMA’ and has brought together policymakers, health leaders, and regulatory experts from across the continent. The African Medicines Agency (AMA), a continental regulatory body to be headquartered in Rwanda, is tasked with creating an enabling regulatory environment for the pharmaceutical industry. In his remarks, Mozambican Minister of Health and the guest of honour, Dr. Armindo Daniel Tiago, acknowledging the strides made by AMRH and congratulated the programme on its 15th anniversary. The minister also pledged Mozambique’s commitment to work towards achieving WHO’s Maturity Level 3 (ML3) in regulatory capacity. Only six African countries, including Zimbabwe that attained it in May, are ML3-licensed. Rwanda is in the final steps of securing the certification. Mozambique is committed to building a strong regulatory system, he said, underscoring how it contributes to the collective agenda of building a resilient health system on the continent. Chimwemwe Chamdimba, head of the AMRH initiative within AUDA-NEPAD, reaffirmed her team’s dedication to supporting Mozambique and other nations on their regulatory journeys. She also highlighted AMRH’s achievements over the years, noting that the programme has streamlined medicine approval processes and provided collaborative regulatory frameworks for member states and regional economic communities (RECs) that make the African Union. Our work helped break down the silos and build trust for countries and regions to jointly work together she said, adding that some countries did not even have in place legal frames to regulate medical products. Reflecting the impact and lessons from the Covid-19 pandemic, Dr. Rogerio Gaspar, Director of Regulation and Prequalification at WHO, emphasized the urgency of stronger regulatory frameworks, pointing to how unequal access to vaccines resulted in over one million preventable deaths. When regulation is weak, people die, he noted, urging the continent to strengthen regulatory systems to better protect populations in future crises. The importance of local production resonated throughout the event. Dr. Abebe Genetu Bayih, Africa CDC’s Platform for Harmonized African Health Products Manufacturing (PHAHM) Coordinator, reminded that recent health crises underscored the need for Africa to ramp up its manufacturing efforts, particularly for vaccines. He also commended AMRH for laying a strong foundation for the African Medicines Agency (AMA) and that the African Union’s specialised agency would be integral to achieving greater self-sufficiency in health product supply. As of June this year, 29 countries had ratified the AMA treaty, and the recruitment process is underway for the agency’s first Director General. The inaugural AMRH Week took place in Kigali in 2018, while the second edition was held virtually owing to the disruptions of the Covid-19 pandemic. Accra, the Ghanaian capital, hosted the third meeting in December 2022.

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Renewed call for unified framework as pharma regulatory forum opens in Maputo