To help academic and non-profit investigators interested in drug repurposing navigate regulatory approval processes, we compared pathways for repurposed drugs to obtain approval at EMA, UK MHRA, and the US FDA. Though we found no pathways specifically for repurposed drugs, pathways to market are available in all repurposing scenarios.

Once an emergency has passed, general attention typically returns to dealing with day-to-day system management, and the opportunity to learn from the crisis and improve is missed. Lessons from the coronavirus disease 2019 (COVID-19) crisis must be learned, and the necessary changes made at all levels, both in terms of improving collaboration and strengthening health systems. This special report provides the conclusion of a workshop held in the European Parliament (EP) in Brussels, Belgium. The event explored the modalities of response and preparation to the COVID-19 pandemic, and to health crises in general. The workshop considered actions at different levels: international organizations (global level), European Union (EU) Member States ([MS] national level), and health services (local level). It provided an opportunity to look back at several initiatives taken during the pandemic, and to draw inspiration from them.

Given the unstoppable spread of coronavirus disease (COVID-19), the development of a vaccine was needed to contain the pandemic. In such a situation of global emergency, regulatory authorities ensured timely, safe, and equitable access to the vaccine.

This article aims to outline the roles of the Tunisian regulatory authority, the Directorate of Pharmacy and Medicines (DPM) at the Ministry of Health, in registration and procurement of the COVID-19 vaccine.

Requirement to grant the Exceptional Provisional Authorizations of Marketing (EPAM) for COVID-19 vaccines was 27 days versus 869 days for conventional marketing authorizations (MAs). The DPM has optimized its activity through: early dialogue with manufacturers, online submission, the use of distance communication technologies. It has demonstrated unprecedented flexibility through the continuous and rolling review approach.

Regulatory authorities in Tunisia and around the world have partnered with manufacturers to speed up administrative procedures while ensuring the quality, safety, and efficacy of vaccines.

Egilman et al. review the current data sharing practices of three global regulatory agencies — Health Canada, the European Medicines Agency and the Food and Drug Agency. While there has been progress towards increasing transparency over the past decade, progress has been slow.