Better evidence, safer medicines: advancing women’s health through research and regulation

A promising vaccine or medicine is only the beginning. To reach the people who need it, clinical research must generate robust evidence of safety and efficacy, and researchers must work closely with regulators to ensure that scientific advances can translate into health benefits. 

For more than two decades, EDCTP-supported research has helped strengthen this connection, bringing African and European researchers together and encouraging early engagement with regulatory authorities. This collaboration is particularly important for populations whose needs have not always been adequately addressed by clinical research, including pregnant and breastfeeding women. 

Closing evidence gaps in women’s health 

Women remain under-represented in some areas of clinical research, and evidence gaps persist around the use of medicines and vaccines during pregnancy and breastfeeding. Without sufficient clinical data, regulators and healthcare professionals may lack the evidence needed to assess the benefits and risks of health interventions for these populations. 

Global Health EDCTP3’s Strategic Research and Innovation Agenda recognises pregnant women as a vulnerable population that is often excluded in clinical research but with major unmet medical needs. The programme’s portfolio includes research addressing women’s health and their specific needs at different stages of life, spanning malaria, HIV, neglected and emerging infections, and other diseases. 

Currently, 22 projects address pregnant women and 16 address breastfeeding women, helping to build an evidence base for these underrepresented patients. Project examples include: 

• PROTECT is creating a network of sites in East Africa to monitor the safety of vaccines administered during pregnancy. 
• SAFIRE is establishing an innovative adaptive clinical trial platform to evaluate antimalarial treatments for women in the first trimester of pregnancy. 
• DOLPHIN-3 is generating evidence on the optimal use of long-acting injectable oral antiretroviral therapy (ART) as a strategy to improve adherence rates and overall health outcomes among postpartum women living with HIV in South Africa and Uganda.

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Connecting research, regulation and policy

The importance of generating better evidence and making clinical research more inclusive was highlighted at the EMA Multistakeholder Workshop on Women’s Health, held on 28-29 September 2026.  

Global Health EDCTP3’s Executive Director, Michael Makanga, joined Emer Cooke, Executive Director of the European Medicines Agency (EMA) and Mimi Darko, Director General of the African Medicines Agency (AMA), alongside healthcare professionals, academics, industry representatives, patients and global partners. Discussions explored persistent gaps in women’s health and ways to strengthen the evidence base through more inclusive clinical research.

A key message was the importance of connecting researchers and regulators to ensure that clinical studies generate evidence that reflects the needs of the people who will ultimately use new health interventions. Accounting for relevant sex and gender differences is an important part of this process, helping researchers and decision-makers better understand how diseases and interventions may affect different populations. 

These discussions reflect a broader commitment to connecting African and European research with regulatory, policy and implementation partners. The aim is to ensure that scientific findings can inform decisions and contribute to better health outcomes. 

A 2025 article in The Lancet Global Health, ‘Europe–Africa collaboration: working together to strengthen health research, implementation, and equitable systems’, co-authored by the Executive Directors of Global Health EDCTP3 and EMA, alongside representatives of other European institutions, highlighted how research funding, regulation, policy and implementation play complementary roles in translating research into impact. 

More than two decades of collaboration delivering results 

The benefits of connecting research and regulatory expertise are already evident in the project portfolio across the EDCTP programmes. Projects have been encouraged to engage with regulators from the early stages of research, including seeking scientific advice. This helps researchers take regulatory requirements into account when designing clinical studies and generating evidence to inform future regulatory decisions. 

Clinical data generated through EDCTP-supported research have contributed to at least 16 medical solutions, six of which have received a positive scientific opinion from EMA under its EU-M4All procedure. 

These innovations include vaccines and medicines targeting malaria, sleeping sickness, schistosomiasis and parasitic worm infections. Some address specific maternal and child health research priorities, illustrating the importance of research that responds to the needs of underserved populations. 

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