Loren Becker

Developing new medical products is a global enterprise, with research and development (R&D) activities spanning national borders and products being introduced in many countries at the same time. A critical part of this global R&D effort is the regulation of new health tools to help ensure that these products are safe and effective before they reach the populations who need them. In countries around the world, regulatory agencies play a critical role in this process, much like the US Food and Drug Administration (FDA) does for health products for American consumers. When creating new tools for diseases of the developing world, product developers sometimes face overlapping and conflicting regulatory processes that can dramatically slow the development and delivery of vital new products to help combat global health scourges like malaria, tuberculosis, and neglected tropical diseases. Delays in the approval of clinical trials can add years to the product development process and can significantly increase costs. Meanwhile, delays in the final approval of a product can lead to unnecessary suffering and death for patients who are unable to access the best possible tools for prevention, diagnosis, and treatment. There has been a lot of talk recently about ways to streamline and harmonize regulatory processes to reduce the time and cost of delivering new products. One such effort is the new East African Community’s (EAC) Medicines Regulatory Harmonization initiative, launched at the end of March in Arusha, Tanzania. Through this program, regulators from six agencies in five East African countries—Burundi, Kenya, Rwanda, Tanzania, and Uganda—as well as Zanzibar will work together to: Establish harmonized procedures for medicines registration. Build regional capacity in regulatory science. Increase access to lifesaving solutions for patients and communities. Representatives from disease-endemic countries, regulatory authorities including the FDA, product development groups, donors and technical partners, and other key stakeholders participated in the launch activities, showcasing the excitement over the steps underway in the region. Participants also highlighted what is at stake in the EAC’s efforts, which are seen as establishing a path forward for other harmonization efforts in regions across Africa and around the world. Over the next several years, support for these efforts—in the form of technical assistance, training opportunities, and political backing—from the FDA and other experienced regulatory authorities will be crucial. The FDA has a vast amount of expertise that can be leveraged to benefit this new initiative, and supporting the EAC would add to recent efforts at the FDA to become increasingly involved in global health issues. By supporting the new EAC regulatory initiative, the FDA can help to make a real impact on the health of patients in East Africa through the delivery of better and safer medicines in the region.