Strong national regulatory and ethics review frameworks for clinical research are essential to protect the interests of research participants and to create a conducive environment for clinical trials. However, many resources to support development of national regulatory and ethics review capacity are in English, disadvantaging Portuguese-speaking countries in the region.

The BERC-Luso project is strengthening links between Portuguese-speaking countries, and between these countries and Portugal. The project aims to develop and strengthen national medicines regulatory systems and ethical review of clinical research in five Portuguese-speaking countries – Angola, Cape Verde, Guinea Bissau, Mozambique, and São Tomé and Príncipe.

The project is engaging with national ethics committees and national regulatory agencies. One key action has been a comparative analysis of the legislative framework for clinical research and regulatory bodies in the five participating countries. These comparisons, and benchmarking against international standards, were fine-tuned at a specially convened workshop in Lisbon, and have been used to create roadmaps for the development of national legislative frameworks in the participating African countries.

The project will also be working to develop the skills and expertise of members of national ethics committees and national regulatory agencies, through an intensive theoretical and practical education programme and training, including internships in Portuguese institutions to apply knowledge.

The project has created a Portuguese-language website to strengthen networking between sites. This includes a digital repository of documents in Portuguese to support national ethics committees and national regulatory agencies activities.