Task B: Convergence of NDA Requirements

The objective of Task B is to make Proposals to facilitate regulatory convergence of NDA requirements based on gap analysis. Specifically, we focus on the following activities:

・To identify the differences in regulatory requirements among APAC member economies.

・Gap analysis of internationally harmonized regulatory guidelines implementation and identify common challenges within the APAC region.

・To support adoption and implementation of the internationally harmonized regulatory guidelines and practices by the regulatory authorities.

Deliverables

・Analysis report
Analysis Report identifies differences in regulatory requirements on drug development from IND (if applicable), clinical trial, NDA and to manufacturing/ post approval (including GMP evaluation system). The report is updated annually so as to maintain the relevance and accuracy of the content.

 Analysis report download:

2013 2014 2015 2016 2017

・Proposal and Fact Sheet
Download: Task B Convergence of NDA Requirements proposal document & Fact sheet