Task B: Convergence of NDA Requirements

Objective of Task B

To promote regulatory convergence of NDA requirements in.Asia

Activities

To identify the differences in regulatory requirements among APAC member countries.

To identify the current status of implementation of the internationally harmonized regulatory guidelines in each APAC member country and 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 2015 (Please refer to “Publications”for previous version)

Task B Convergence of NDA Requirements proposal document & Fact sheet