Background The Biomedical Ethics and Regulatory Capacity Building for Portuguese Speaking African Countries Project (BERC-Luso) was a four-year initiative that aimed to enhance biomedical ethics and regulatory capacities in Angola, Cape-Verde, Guinea Bissau, Mozambique, São Tomé and Príncipe, and Portugal. The project established a network of National Ethics Committees (NCEs), National Regulatory Authorities (NRAs), and experts in biomedical research, developed a comparative legislative study, and created educational programs to promote capacity building. The digital repository in Portuguese language served as an example for similar projects and supported complementary actions beyond the project’s term.

Methods A set of indicators was developed to measure the project’s impact, and the evaluation was carried out through public and grey literature and event reporting. The indicators were linked to concrete actions that leveraged institutional, legislative, and capacity-building development. Score points were attributed to each indicator, with calculation of score mean values.

Results In all partner countries, a high level of success (78.59%) was achieved by meeting the goals set at the beginning of the project via the roadmap. A total of 311 activities were developed, impacting at least 3,848 professionals from different backgrounds. Over 172 hours of training were delivered, and the project registered mass dissemination through television broadcast, radio, and media in at least six countries.

Conclusion Overall, the BERC-Luso Project had a significant impact on every participating country, visible through the long-lasting effects of the successful implementation of the bottom-up and top-down approaches. The project trailblazed capacity building in ethical and regulatory revision in the partner countries, but there is still a need for further investment in legislative, institutional, and training levels to reinforce the implementation of best practices.