Pharmaceutical regulators and academia come together in Accra to validate the Regional Centres of Regulatory Excellence’s new M&E tool

Nancy Ngum and Paul Tanui (AUDA-NEPAD), Ms. Mimi Darko (Ghana FDA), and Kate Kikule (MTaPS)

Regional regulatory leaders, representatives from academia, and development organizations gathered in Accra, Ghana, in June to review a new monitoring and evaluation (M&E) tool that promises to improve access to safe, affordable medicines in several African countries by measuring the performance of Regional Centres of Regulatory Excellence (RCOREs).

The African Union Development Agency (AUDA-NEPAD), in collaboration with the USAID-funded Medicines, Technologies, and Pharmaceutical Services (MTaPS) program, supported the validation of the M&E tool. It aims to monitor the performance of 11 RCOREs organizations with pharmaceutical regulatory science expertise and training capability to train medicines regulators. The RCOREs are located in Burkina Faso, Ghana, Kenya, Nigeria, South Africa, Tanzania, and Uganda.

[Workshop participants]Workshop participants

Safe, good quality, and reasonably priced medicines are out of reach for the majority of people in Africa. One reason is that many countries lack the regulatory infrastructure and human resources to efficiently approve medicines for sale. Medicines registration is a complex process that requires applicants to provide significant, varied, and quality science data.

Weak regulations also lead to frequent delays and a lack of transparency in the medicines review process. Regulatory capacity has been identified as a key intervention to improve medicines access as it also has positive effects on other regulatory interventions, such as faster medicines registration processes, control of substandard and falsified medicines on the market, and better confidence in the pharmaceutical regulatory system.

Representatives from the RCOREs, AUDA-NEPAD, USAID, MTaPS, FHI360, and the United States Pharmacopeia Convention attended the event. Participants reviewed and validated the M&E tool, which will be utilized to measure the baseline performance of the designated organizations and institutions this year 

Ms. Mimi Delese Darko, Chief Executive Officer of the Ghana Food and Drug Authority, officiated the opening of the validation workshop and commended the contributions of participants and the support offered by USAID toward building regulatory capacity in Africa. She also thanked NEPAD for promoting coordination among country regulatory agencies through this initiative.

After this strategic meeting, the validated M&E tool will be rolled out for implementation by the RCOREs.

[Workshop participants]Workshop participants