COVID-19 Vaccines and Roles of the Health Regulatory Authority in Tunisia

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 Tun...

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Bibliographic Details
Published in:Disaster Medicine and Public Health Preparedness 2022-07, Vol.16 (6), p.1-2696
Main Authors: Chtiba, Nour, Cherif, Dora, Mersni, Imène, Kadri, Meriem, Jemei, Aroua, Lassoued, Imed, Razgallah Khrouf, Myriam
Format: Article
Language:English
Subjects:
Clinical trials
Collaboration
COVID-19
COVID-19 vaccines
Disease transmission
Epidemics
Laboratories
Manufacturers
Meetings
Pandemics
Pharmaceutical industry
R&D
Registration
Regulatory approval
Report from the Field
Research & development
Severe acute respiratory syndrome coronavirus 2
Vaccines
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Summary: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.
ISSN:1935-7893
1938-744X
DOI:10.1017/dmp.2022.200