Task A: APAC Position Paper

Objective of APAC Position Paper

To provide high level suggestions and proposals to the regulatory authorities from the viewpoint of industry

By facilitating close communication and collaboration between industry and the regulatory authorities based on this document, it is expected to improve regulatory environment for Good Registration Management and achieve regulatory standardization which can facilitate future regulatory convergency and work sharing of drug review in Asia.

Five topics of APAC Position Paper

APAC Position Paper covers five topics, (1) Consultation, (2) Transparency, (3) Tracking system, (4) Collaborative training, and (5) Review report in English, which are selected as important area for refining existing drug registration process throughout the APAC region.

Goal of five topics

TOPIC #1 To establish structured framework to support regulatory consultation
TOPIC #2 To facilitate transparency to review policy, standards, draft regulations, guidelines, and new initiative from regulatory authority
TOPIC #3 To facilitate transparency to review process and status
TOPIC #4 To facilitate collaborative training program and workshop between the regulatory authorities and industry
TOPIC #5 To facilitate generation of review report in English.
- It will help towards building mutual confidence across the regulatory authorities and may lead to future work sharing in drug review


APAC Position Paper