The African Union Development Agency-NEPAD’s (AUDA-NEPAD) -African Medicines Regulatory Harmonization Initiative (AMRH) -is marking a significant milestone with its 1st Continental Dossier Assessment Plenary to advance the continental procedure on the evaluation of medical products.
According to AMRH the 1St Continental Dossier Assessment Plenary pilot aims to validate the continental evaluation procedures developed and endorsed by AMRH Steering Committee during the Assembly of the 9th African Medicines Regulators Conference (AMRC).
The validation will ensure that the procedures are effective and adaptable to the unique needs of African countries.
“The lessons learned from this pilot will refine our processes and lay a foundation for a robust African Medicines Agency (AMA),” said Mr Farai Bhudhe Masekela, EMP-TC Chairperson.
The AMRH inaugural event will be followed by the 10th meeting of the Evaluation of Medicinal Products Technical Committee (EMP-TC), aims to advance the continental procedure on the evaluation of medicinal products pilot.
“In collaboration with the Good Manufacturing Practices Technical Committee (GMP-TC), over 100 dossier assessors from across Africa are gathering on-site and virtually for the first continental dossier plenary session,” AMRH revealed.
The session will culminate in the 10th Ordinary Meeting of the EMP-TC, where assessments will be consolidated, and expert recommendations on the evaluated products will be endorsed. This historic convening is pivotal for Africa’s healthcare landscape, aiming to transform how medicinal products are assessed and approved across the continent.
Enhancing Collaborative Efforts
The pilot will facilitate the national authorization of products recommended by the EMP-TC, fostering a network of regulators across Africa. This approach enables regulators to share information and rely on each other’s decisions, enhancing the efficiency of medicine regulation.
“Evaluation process by the EMP-TC involves assessing the quality, safety, and efficacy of priority medicinal products and ensuring compliance with GMP, Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) standards.”
The approved products which have met all the stringent standards will receive an independent scientific opinion, allowing inclusion in the continental list of recommended medicinal products.
Assessment reports will support National Regulatory Agencies (NRAs) in registering and authorizing mecinial products, streamlining the process and ensuring high-quality medicines reach the market efficiently.
“By validating these rigorous procedures, we aim to transform medicinal product assessment in Africa,” said Alex Juma Ismail, Regulatory Systems Strengthening Lead – AMRH. This week is a historic moment and game changer for the continent as we are convening the first ever continental joint dossier assessment. “This pilot underscores our commitment to providing safe and effective medicines for millions of Africans.
