National medicines regulatory authorities in Africa face many challenges, including inadequate legal frameworks and incomplete structures such as guidelines or standard operating procedures. This leads to uncertainty among employees. These in turn lead to slower processing and decisions on marketing authorisation for new medicinal products. The aim of regional and continental harmonisation programmes in Africa is therefore the development and transnational harmonisation of standards in order to improve the efficiency and capacities of the authorities and thus the supply of high-quality, effective and safe medicines to the population. One such programme is the Harmonisation Initiative for Pharmaceutical Regulation (AMRH) of the African Union, specifically the African Union Development Agency - New Partnership for Africa's Development (AUDA-NEPAD). In addition, there are several associations within African Regional Economic Communities^[1] (REC) for the joint assessments of medicines, such as EAC-MRH, WAHO-MRH or ZaZiBoNa (SADC). A number of advanced national medicines regulatory authorities are committed as Regional Centres Of Regulatory Excellence (RCORES) to train staff from their own and other regulatory authorities. The highlight in the expansion of capacities and standardisation of processes is the African Medicines Agency (AMA), which has been under development since 2019. Its operationalisation will mark the beginning of a new era for the African continent, ensuring improved regulation of medicines across countries as well as safe and effective supply.

The PharmTrain2 project contributes significantly to these efforts by supporting the harmonisation and standardisation of medicines regulation at regional and continental levels through capacity development and structural development activities.

The PharmTrain2 project activities for harmonisation include:

1. Regional Trainings

The PharmTrain fellowships’ structures lay the foundation for harmonisation in medicines regulation by involving fellows from four RCORE partner authorities from three different economic regions. The knowledge gained in the fellowship programme is passed on to colleagues in regional training sessions (virtual or on-site). In this way, the training task is spread across several authorities. In addition, the joint training sessions strengthen networking and the further development of expertise. Moreover, the fellowship classes are expected to play an important role in the continental assessment of medicinal products.

2. Continental Development of Structures

 The PharmTrain2 project is a partner of AUDA-NEPAD and supports the work of the "AMRH Partnership Platform" as an active member. The development of the African Medicines Agency (AMA), in which the AMRH initiative plays a key role, is in the focus of the project. The AMA will issue authorisation recommendations for selected medicinal products, thereby simplifying and accelerating the processes in the individual countries. The PharmTrain2 project is involved in the development of continental guidelines and procedural instructions. The project team's proposal to form a continental working group for this purpose has already been accepted. The work of this group will be support by the PharmTrain2 project in terms of organisation and expertise.

^{[1] East African Community (EAC); Economic Community of West African States (ECOWAS); Southern African Development Community (SADC).}

Highlights:

• February 2024: Online Training for Assessors in the West African Economic Area (ECOWAS, WAHO-MRH).
• February 2024: AUDA-NEPAD Workshop on the Development of a Scientific Advice Procedure and Guideline on Emergency Use Listing for Africa, Johannesburg, South Africa.
• October 2023: Trainings in Cape Town at the Joint Assessment for Assessors in the Southern African Economic Zone (ZaZiBoNa).
• October 2023: AUDA-NEPAD EMP-TC Retreat to Develop Continental Guidelines for implementation of the Pilot Continental Evaluations of Priority Medicinal Products, Cape Town, South Africa.
• November 2022: Regine Lehnert was elected as vice chair of the AMRH Partnership Platform.