Alignment in post-approval changes (PAC) guidelines in emerging countries may increase timely access to vaccines: An illustrative assessment by manufacturers

Alignment in post-approval changes (PAC) guidelines in emerging countries may increase timely access to vaccines: An illustrative assessment by manufacturers

A comparison of the regulations and guidelines from 33 countries, across different regions, on the requirements and procedures for the management of chemical, manufacturing and control (CMC) changes for vaccines, also known as post- approval changes (PACs), reveals significant variability and lack o...

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Bibliographic Details
Main Authors: Nora Dellepiane, Sonia Pagliusi, Prashant Akut, Sebastian Comellas, Norbert De Clercq, Shubhangi Ghadge, Thierry Gastineau, Mic McGoldrick, Ida Nurnaeni, Lorenz Scheppler
Format: Article
Language:English
Published: Elsevier 2020-12-01
Series:Vaccine: X
Subjects:
Vaccine access
Variations guidelines
Post-approval changes
Regulatory science
Changes classification
Regulatory convergence
Online Access:http://www.sciencedirect.com/science/article/pii/S259013622030022X

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http://www.sciencedirect.com/science/article/pii/S259013622030022X

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