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

Published online by Cambridge University Press:  28 July 2022

Nour Chtiba Open the ORCID record for Nour Chtiba [Opens in a new window] ,
Dora Cherif ,
Imène Mersni ,
Meriem Kadri ,
Aroua Jemei ,
Imed Lassoued  and
Myriam Razgallah Khrouf
Nour Chtiba*
Affiliation:
Faculty of Pharmacy of Monastir, University of Monastir, Monastir, Tunisia Directorate of Pharmacy and Medicines, Ministry of Health, Tunis, Tunisia
Dora Cherif
Affiliation:
Faculty of Pharmacy of Monastir, University of Monastir, Monastir, Tunisia Directorate of Pharmacy and Medicines, Ministry of Health, Tunis, Tunisia
Imène Mersni
Affiliation:
Directorate of Pharmacy and Medicines, Ministry of Health, Tunis, Tunisia
Meriem Kadri
Affiliation:
Directorate of Pharmacy and Medicines, Ministry of Health, Tunis, Tunisia
Aroua Jemei
Affiliation:
Directorate of Pharmacy and Medicines, Ministry of Health, Tunis, Tunisia
Imed Lassoued
Affiliation:
Directorate of Pharmacy and Medicines, Ministry of Health, Tunis, Tunisia
Myriam Razgallah Khrouf
Affiliation:
Faculty of Pharmacy of Monastir, University of Monastir, Monastir, Tunisia Directorate of Pharmacy and Medicines, Ministry of Health, Tunis, Tunisia
*
Corresponding author: Nour Chtiba, Email: n.chtiba@gmail.com.
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Abstract

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.

Keywords

assessmentCOVID-19exceptional provisional authorizations of marketingfast-track of vaccine registration and procurementhealth regulatory authority
Type
Report from the Field
Information
Disaster Medicine and Public Health Preparedness , Volume 16 , Issue 6 , December 2022 , pp. 2694 - 2696
Copyright
© The Author(s), 2022. Published by Cambridge University Press on behalf of Society for Disaster Medicine and Public Health, Inc

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