South Korea's Ministry of Food and Drug Safety announced Friday that it has pre-announced draft subordinate regulations under the Special Act on Regulatory Support for Biopharmaceutical Contract Development and Manufacturing Organizations — commonly known as the CDMO Regulatory Support Special Act — to strategically bolster the country's biopharmaceutical CDMO industry.
The draft enforcement decree and implementing rules, prepared ahead of the law's Dec. 31 entry into force, set out tailored support measures and detailed regulatory standards for biopharmaceutical CDMO companies and raw-material manufacturers.
The draft enforcement decree covers facility standards for biopharmaceuticals produced for export, requirements for designating institutions to train CDMO specialists, and the basis for imposing administrative fines. The draft implementing rules address the registration procedure for export-oriented biopharmaceutical manufacturers, Good Manufacturing Practice certification, raw-material manufacturing and quality certification procedures, and details of pre-review regulatory support.
Under the draft rules, manufacturing facilities producing biopharmaceuticals for export must generally follow domestic Pharmaceutical Affairs Act facility standards, but may also comply with the importing country's regulations to ease overseas market entry. The draft also introduces a new quality management system and certification procedure for "raw materials" — the key starting substances for biopharmaceuticals, such as cell lines and vectors.
To ease the licensing burden on companies, the draft introduces a pre-review system and establishes a standard customs clearance advance reporting procedure through the Korea Pharmaceutical Traders Association, allowing rapid imports of raw materials needed for CMO operations. The Vaccine Safety Technology Support Center and similar bodies will be designated as specialist training institutions to build a pipeline of field-ready professionals.
Codifying a full-cycle regulatory support framework to help domestic companies clear the varying regulatory barriers of different importing countries is expected to significantly strengthen the global competitiveness of South Korea's biotech industry in the fast-growing global CDMO market.
The ministry plans to collect industry feedback during the pre-announcement period through Sept. 4 before completing the enactment process. "Through this subordinate legislation, we will give concrete shape to the institutional foundation for nurturing the CDMO industry," a ministry official said. "We will actively support South Korea's emergence as a key global biotech production hub."
silverpaper@heraldcorp.com
