Korea food and drug ministry meets cell-culture media makers on raw-material certification

South Korea's food and drug safety ministry said Wednesday it visited a company preparing to certify cell-culture media, a core input in biopharmaceutical manufacturing, to hear where the certification process is tripping up smaller producers and input suppliers.

The visit follows the ministry's Oct. 23 announcement, at a meeting of the presidential committee on regulatory rationalization, that it would introduce certification for raw materials — cell lines, cell banks, vectors and media — to help domestic contract development and manufacturing organizations and their suppliers win business overseas and reduce reliance on imports. The government would certify the production and quality-control standards of the inputs from which biopharmaceuticals are made; most such materials have been imported, and the ministry wants a more stable supply chain behind Korean manufacturers. The ministry had said at the committee that the export manufacturing category, CDMO GMP certification and the raw-material certification scheme would support Korean CDMO companies and raw-material producers in overseas markets and promote domestic sourcing.

Wednesday's meeting brought together suppliers of raw materials and the drugmakers that buy from them, and participants discussed what support the certification regime would bring and how using certified materials could cut duplicated paperwork, according to the ministry.

"Regulatory rationalization is only complete when companies feel it on the ground," Minister of Food and Drug Safety Oh Yu-kyoung said, adding that the ministry would fold the industry's suggestions into policy to help raise the quality and reliability of Korean-made raw materials to global levels. She added that the ministry would continue to communicate with the industry and pursue regulatory support that companies can feel.

The law underpinning these measures — a special act on regulatory support for contract development and manufacturing companies — takes effect on Dec. 31, 2026.

Ahead of that date, the ministry plans to publish a guide to the documents companies must submit for raw-material certification and a separate guideline on producing and controlling the quality of those materials in early December, it said. It also said it will train specialists to handle certification reviews, and that it will keep hearing industry views and refining the system after it takes effect.