Pharmaceuticals

Proposed amendments to the Regulation on Safety of Pharmaceuticals

To organize the matters entrusted by the Act, such as the GMP compliance determination subject, documents for GMP compliance determination application, GMP inspection procedure and GMP training, requirements for designation of training institutions, and designation application document and designation procedure, and matters necessary for its implementation, as the Pharmaceutical Affairs Act was revised (Act No. 18970, Notification Date June 10, 2022, Enforcement Date December 11, 2022), which intends to provide a basis for taking measures such as GMP compliance determination, GMP inspection and cancellation of the determination in case of violation and for implementing training for GMP inspectors.