CTD Speeding Medicines Registration in East Africa

David Mukanga, Senior Program Officer Regulatory Affairs, Africa Systems, Bill & Melinda Gates Foundation (and Africa Regional Editor for DIA Global Forum) explores the East African Community’s Medicines Regulatory Harmonization (EAC MRH) initiative with Margareth Sigonda, Head of Health Programs for The New Partnership for Africa's Development, the African Union development agency. “Before this initiative was launched in the EAC, each country had different requirements, different formats for dossier submission,” Margareth explains. “Therefore, adopting the CTD was really a game changer in terms of how now the countries were in a position to receive applications that were kind of in a similar format.”