0
Ministry of Food and Drug Safety headquarters. / Ministry of Food and Drug Safety

South Korea's Ministry of Food and Drug Safety has created an opportunity to strengthen biosimilar regulatory capacity across the Asia-Pacific region, in partnership with the World Health Organization (WHO).

The ministry's National Institute of Food and Drug Safety Evaluation announced on the 21st that it will co-host a "Workshop on Implementation of Biosimilar Evaluation Guidelines" with the WHO over three days, from the 24th to the 26th.

Held under the theme "Promoting Regulatory Harmonization for Biosimilars," this workshop marks the first such event held in Asia-Pacific, hosted in South Korea. About 40 participants are expected to attend, including officials from major overseas regulatory agencies such as China's National Medical Products Administration, the Philippine Food and Drug Administration, and Hong Kong's Department of Health, along with WHO officials and domestic and international biosimilar experts, all working to promote implementation of biosimilar evaluation guidelines and explore ways to advance regulatory harmonization.

The workshop's main program includes lectures from international experts on the core content of WHO's biosimilar evaluation guidelines, group discussions on case studies of guideline implementation in the field of monoclonal antibody biosimilars, and focused discussions aimed at bridging perspective gaps between regulators and industry.

The ministry has previously played an active role in collaborating with the WHO on developing and revising biosimilar evaluation guidelines, and has also published its own guidelines for evaluating the quality of biosimilar medicines, having helped lead the world's first approval of an antibody biosimilar.

A ministry official said, "We expect this event to broaden mutual understanding among regulators and industry experts from various countries and contribute to strengthening review expertise through regulatory harmonization for biosimilars across the Asia-Pacific region," adding, "We will continue leading international regulatory harmonization through cooperation with the WHO, building a solid regulatory foundation to support the active overseas expansion of Korea's biopharmaceutical industry."

                                                                                                           Seo Byung-ju