South Korea Revises Licensing and Review Regulations for Biological Products

On June 26, 2023, the Ministry of Food and Drug Safety (MFDS) of South Korea submitted Notification G/TBT/N/KOR/1150 to the WTO, proposing revisions to the Regulations on Licensing and Review of Biological Products, etc. The goal of the revisions is to further strengthen the safety of domestic biological products. As of August 25, 2023, these revisions are in the public consultation phase.

China is the worlds second-largest biologics market, with related product exports increasing annually. In 2022 alone, Chinas pharmaceutical exports to South Korea reached $1.257 billion. Currently, South Korea is Chinas top export destination for western drug preparations, making this revision highly impactful for Chinese exporters. Export enterprises should pay close attention to the content changes in this revision and adjust product strategies promptly to avoid unnecessary trade losses.

(1) Definition of new terms: Definitions for new terms such as live bacterial preparations;
(2) Quality system audit requirements: Established quality audit requirements for Quality by Design (QbD) systems (Articles 4 and 26 of the proposal);
(3) Scientific citation index scope expansion: Broadened the range of materials recognized as pharmacological effects and clinical trial evidence (Article 7 of the proposal);
(4) Improved stability test data submission requirements: Changed the submission requirements for stability test data when modifying manufacturing methods;
(5) Risk Management Plan (RMP) submission procedures: Added mandatory RMP submission procedures for self-injection products approved by MFDS;
(6) RNA and DNA vaccine evaluation standards: Established evaluation standards for RNA and DNA vaccines.