Regulatory Affairs Committee
KRPIA enhances to raise patient accessibility to new drugs by improving regulatory environment and by leading the harmonization of local and global standards
- Improve the process of new drug approval system and management of post-approval changes.
- Deliver and voice out the industry’s opinion as a reliable policy partner
- Lead the local implementation of ICH Guidelines through hosting workshop, training session those are opened to whole industry including local companies
- Promote the environment and related systems for adopting digital healthcare (ex. e-CTD, e-Labeling, use of RWD/RWE)
- Timely monitor the regulatory environment and take an appropriate action when needed
- Improve the New Drug Approval-Patent Linkage System