Given the unstoppable spread of 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, procurement of the COVID-19 vaccine.
27 days was required to grant the Exceptional Provisional Authorizations of Marketing (EPAM) for COVID-19 vaccines 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.