PharmTrain3
Developing and Multiplying Regulatory Capacities: Marketing Authorisation of Medicinal Products
Context
Rising outbreaks of infectious diseases, growing antimicrobial resistance and chronic diseases pose major challenges to health systems worldwide. Strong, well-functioning medicines regulatory authorities help ensure that people can access safe, effective and quality-assured medicines and vaccines in time. This supports a reliable drug supply and reduces pressure on healthcare systems. According to estimates from the World Health Organization, improved access to and safe use of medicines and vaccines could save up to 10 million lives each year. However, in many sub-Saharan African countries, the necessary resources and expertise to evaluate medicines reliably and efficiently are currently insufficient. PharmTrain3 addresses this gap by strengthening staff of national medicines authorities. Using a train-the-trainer approach, participants are equipped to become trainers themselves, with a focus on clinical assessment and biological medicines. They then share this expertise through regional courses, building capacity and enabling sustainable knowledge transfer. This also supports a trusted network that promotes cooperation across borders. The project builds on PharmTrain2 and works closely with national authorities as well as regional and international partners, including the African Union Development Agency, the African Medicines Agency, and the World Health Organization.
Objective
Improved medicine safety in Africa by strengthening and scaling up regulatory capacity for assessing marketing authorisation applications across participating national regulatory bodies
In Cooperation with
- African Union Development Agency-New Partnership for Africa’s Development Agency (AUDA-NEPAD), Midrand, South Africa
- Egyptian Drug Authority (EDA), Cairo, Egypt
- Food And Drugs Authority (FDA) Ghana, Accra, Ghana
- Food and Drug Authority (FDA) Rwanda, Kigali, Rwanda
- Medicines Control Authority of Zimbabwe (MCAZ), Harare, Zimbabwe
- National Agency for Food and Drug Administration and Control (NAFDAC) Nigeria, Abuja, Nigeria
- National Drug Authority (NDA) Uganda, Kampala, Uganda
- Pharmacy and Poisons Board (PPB) Kenya, Nairobi, Kenya
- SADC-MRH Secretariat (Hosted by: Medicines Control Authority of Zimbabwe (MCAZ), Harare, Zimbabwe
- South African Health Products Regulatory Authority (SAHPRA), Pretoria, South Africa
- Tanzania Medicines and Medical Devices Authority (TMDA), Dar es Salaam, Tanzania
- World Health Organization (WHO), Geneva, Switzerland
- Paul-Ehrlich-Institut, Germany
Thematic priorities
Facts
Activities
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Networking and cooperation
The project strengthens networking and cooperation among African medicines regulatory authorities across countries and regions. Regular exchange and long-term collaboration build trust and support mutual recognition of regulatory decisions. The project also supports technical committees linked to the African Medicines Agency (AMA) and contributes to its step-by-step operationalisation.
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Capacity building
National medicine authorities’ assessors receive targeted training using structured training materials. They provide core knowledge and a consistent approach to clinical assessment and the evaluation of biosimilars. Regional courses and eLearning modules ensure its long-term availability and enable sustainable knowledge transfer across countries and regions.
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Training and competence development
Train-the-trainer fellowships and regional training courses enhance indi-vidual skills in assessing marketing authorisation applications. They particularly focus on clinical assessment and biological medicines (including biosimilars and synthetic peptides). Alumni deliver follow-up training series while a new cohort starts in parallel. The content aligns with international guidelines (WHO/ICH) and is illustrated with practical examples.
