By Gabs Mia
Addis Ababa, Ethiopia: The African Union Development Agency-NEPAD’s (AUDA-NEPAD) African Medicines Regulatory Harmonization Initiative (AMRH) is celebrating a major milestone this week with its inaugural Continental Dossier Assessment Plenary.
This event, occurring in conjunction with the 10th meeting of the Evaluation of Medicinal Products Technical Committee (EMP-TC), intends to further develop the continental procedure for evaluating medicinal products on a pilot basis. Over 100 dossier assessors from across Africa are assembling both in-person and virtually for this historic plenary session, partnering with the Good Manufacturing Practices Technical Committee (GMP-TC).
The 10th Ordinary Meeting of the EMP-TC will be the culmination of the session, at which point assessments will be consolidated and expert recommendations on the evaluated products will be endorsed. This historic convening is a pivotal moment for Africa’s healthcare landscape, as it aims to revolutionize how medicinal products are assessed and approved across the continent.
With the objective of validating the continental evaluation procedures, the pilot project seeks to assess their effectiveness and adaptability to the specific requirements of African countries. These procedures were developed and approved by the AMRH Steering Committee during the Assembly of the 9th African Medicines Regulators Conference (AMRC).
This validation process aims to ensure that the procedures are tailored to meet the unique needs and circumstances of African countries, ensuring their successful implementation and application.
“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
Enhancing Collaborative Efforts
In order to foster a network of regulators across Africa, the pilot project will oversee the national authorization of products recommended by the EMP-TC. This approach allows for the sharing of information and reliance on decisions made by fellow regulators, enhancing the efficiency of medicine regulation.
The evaluation process conducted by the EMP-TC entails a comprehensive assessment of the quality, safety, and efficacy of prioritized medicinal products, ensuring adherence to established standards such as GMP (Good Manufacturing Practice), GCP (Good Clinical Practice), and GLP (Good Laboratory Practice).
Products that meet rigorous standards and receive independent scientific endorsement will be eligible for inclusion in the continental list of recommended medicinal products. These assessment reports will aid National Regulatory Agencies (NRAs) in streamlining the registration and authorization processes for these products.
This streamlined approach will facilitate the efficient delivery of high-quality medicines to the market, ensuring their availability to patients in a timely manner.
“By validating these rigorous procedures, we aim to transform medicinal product assessment in Africa,” said Alex Juma Ismail, Regulatory Systems Strengthening Lead – AMRH.
In a significant milestone for the continent, Alex highlighted this week as a game changer. For the first time, a continental joint dossier assessment is being convened, marking a historic moment in our history in Africa.
“This pilot underscores our commitment to providing safe and effective medicines for millions of Africans” urged Alex.
