[Background]

The Special Act on Regulatory Support for Biopharmaceutical Contract Development and Manufacturing Organizations, etc. was enacted (Act No. 21297, promulgated on December 30, 2025) to establish a legal framework for supporting biopharmaceutical CDMOs, thereby securing the domestic biopharmaceutical supply chain for public health while creating an institutional environment where enterprises can expand exports and lead the global market within a proactive and predictable regulatory landscape. Accordingly, this Enforcement Rule aims to stipulate matters delegated by the Act and its Enforcement Decree—as well as those necessary for implementation—including the registration of biopharmaceutical export manufacturing businesses, compliance certification for biopharmaceutical CDMO and quality control standards, manufacturing and quality certification for biopharmaceutical raw materials, and procedures for applying for regulatory support.

[Main Points]

A. Procedures for Registering Biopharmaceutical Export Manufacturing Businesses (Draft Articles 2 through 3)

Any person intending to register a biopharmaceutical export manufacturing business shall submit a physician's medical certificate proving no grounds for disqualification, along with documents verifying compliance with facility standards, to the Director of the Regional Food and Drug Administration (hereinafter referred to as the "Regional Director").

Facility standards shall apply mutatis mutandis to the Enforcement Rule of the Regulations on Facility Standards of Pharmaceutics and In-vitro Diagnostic Reagents, Manufacturers and Importers; however, regulatory burdens are eased to allow compliance with the importing country's regulations if the manufacturing is solely for export purposes.

B. Compliance Certification Procedures for CDMO and Quality Control Standards (Draft Article 9)

Any person seeking compliance certification shall apply to the Regional Director by submitting a Site Master File (SMF), product specification files, and validation data.

In cases deemed necessary by the Minister of Food and Drug Safety—such as for novel dosage forms or manufacturing methods (including formulations)—on-site inspections may be conducted on a priority basis.

C. Manufacturing and Quality Certification Procedures for Biopharmaceutical Raw Materials (Draft Article 14)

Any person seeking manufacturing and quality certification for biopharmaceutical raw materials shall apply to the Regional Director by attaching documentation regarding facilities, equipment, personnel, and raw material quality.

The Regional Director may request cooperation from the head of the Vaccine Safety Technology Support Center when conducting on-site inspections for raw material evaluations.

D. Establishment of Regulatory Support Procedures, Including Preliminary Reviews and Technical Support (Draft Article 16)

Procedures—such as the scope of documents to be submitted and methods for notifying review results—are established to enable applications for preliminary reviews and technical support in advance of compliance and raw material certifications.