Challenges for the registration of vaccines in emerging countries:Differences in dossier requirements application and evaluation processes

摘要

The divergence of regulatory requirements and processes in developing and emerging countries contributes to hamper vaccines’ registration, and therefore delay access to high-quality, safe and efficacious vaccines for their respective populations. This report focuses on providing insights on the heterogeneity of registration requirements in terms of numbering structure and overall content of dossiers for marketing authorisation applications for vaccines in different areas of the world. While it also illustrates the divergence of regulatory processes in general, as well as the need to avoid redundant reviews, it does not claim to provide a comprehensive view of all processes nor existing facilitating mechanisms, nor is it intended to touch upon the differences in assessments made by different regulatory authorities. This report describes the work analysed by regulatory experts from vaccine manufacturing companies during a meeting held in Geneva in May 2017, in identifying and quantifying differences in the requirements for vaccine registration in three aspects for comparison: the dossier numbering structure and contents, the application forms, and the evaluation procedures, in different countries and regions. The Module 1 of the Common Technical Document (CTD) of 10countries were compared. Modules 2–5 of the CTDs of two regions and threecountries were compared to the CTD of the US FDA. The application forms of eightcountries were compared and the registration procedures of 134 importingcountries were compared as well. The analysis indicates a high degree ofdivergence in numbering structure and content requirements. Possibleinterventions that would lead to significant improvements in registrationefficiency include alignment in CTD numbering structure, a standardisedmodel-application form, and better convergence of evaluationprocedures.