What is the CDMO Regulatory Support Act?
Korea's Ministry of Food and Drug Safety has issued a legislative notice for the enforcement decree and enforcement rules of the "Special Act on Regulatory Support for Biopharmaceutical Contract Development and Manufacturing Companies." With the act set to take effect on December 31, this establishes a tailored support framework designed to strengthen Korean companies' competitiveness in the global CDMO (contract development and manufacturing organization) market, now valued at roughly KRW 35 trillion.
Key Contents of the Subordinate Legislation
Facility standards for export-purpose biopharmaceuticals: Specifies requirements for manufacturing facilities intended for exportDesignation requirements for CDMO workforce training institutions: Supports securing specialized talent through government-recognized training institutionsExport manufacturing registration procedures for biopharmaceuticals: Establishes a dedicated registration system for exportsGMP conformity and raw material certification procedures: Sets out procedures for manufacturing/quality management standard (GMP) conformity certification and raw material manufacturing/quality certificationPre-review system: Includes a procedure to confirm regulatory conformity before formal certification or registrationWho Stands to Benefit
Biopharmaceutical contract development and manufacturing (CDMO) companiesRaw material manufacturersBio SMEs preparing to exportPreparation Strategy
Review export manufacturing registration requirements (facility standards) in advanceBuild a talent acquisition plan using CDMO workforce training institution programsUse the pre-review system for GMP conformity and raw material certification to shorten certification timelinesCheck the finalized enforcement rules and detailed forms before the act takes effect on December 31Contact KITIM
KITIM supports bio SMEs with CDMO-related regulatory response, export manufacturing registration preparation, and linking to government R&D and certification support programs. Contact us through [KITIM Contact](/contact) if you need support responding to the CDMO Regulatory Support Act.
