1. Reasons for Amendment

The amendment to the Pharmaceutical Affairs Act (Act No. 18970, promulgated on Jun. 10, 2022, enforced on Dec. 11, 2022) prescribes that it shall create the grounds for the manufacturing and quality control standards for pharmaceutical drugs, etc. (hereinafter referred to as “GMP”), assessment and investigation of the compliance with GMP, measures such as the revocation of compliance in the event of any violation of GMP, and education and training of the manufacturing and quality control investigators. Accordingly, this partial amendment will set out the matters entrusted by the Act, including those entities required to undergo GMP compliance assessment, documents to be submitted for the application, procedures for the assessment and inspection of compliance with GMP, requirements of education and training institutions for manufacturing and quality control standards, documents for designation application and designation procedures, and other matters necessary for the implementation thereof, in line with the amendment to the Act.

2. Major Provisions

A. Development of a GMP compliance assessment procedure and standard for revocation of compliance.

Develop the operating procedures for the GMP compliance assessment system, including documents to be submitted for application for compliance assessment, assessment and investigation of compliance with GMP, issuance of an assessment report, and the order to enforce a corrective action or revocation of compliance assessment in the event of any GMP violation.

B. Provisions on the requirements and procedures for designating GMP education and training institutions.

Designate the Korea Institute of Drug Safety and Risk Management, pharmaceutical organizations under Article 67 of the Act, or universities with drug-related departments and majors as institutions for education and training of GMP inspectors, and prescribe the documents to be submitted to apply for the designation as an institution for education and training of manufacturing and quality control standards, and the procedure for a certificate issued by the Minister of Food and Drug Safety concerning designation as an institution for education and training of manufacturing and quality control standards.

C. Development of the administrative disposition mitigating standards for voluntary reports of GMP violations, the violation of provision standards who obtain a small amount of financial gain, and the delayed reporting of serious adverse drug reactions (attached Table 8, subparagraph 12).

Develop the administrative disposition mitigating standards for pharmaceutical drug manufacturers and the like who voluntarily report a GMP violation, violators of the provision standards who obtain a small amount of financial gain, and persons authorized to approve items such as pharmaceutical drugs who report serious adverse drug reactions as they have failed to comply with the reporting deadline due to natural disasters. etc.