The Ministry of Food and Drug Safety (MFDS) has revealed plans to streamline the process for Drug Master File (DMF) registration of imported raw materials by abolishing current requirements. Jung-Yeon Kim, Manager of the Pharmaceutical Quality Division at MFDS, unveiled these reforms during a recent pharmaceutical policy briefing.

Kim outlined the MFDS's objective to simplify GMP evaluation requirements for raw material registration, emphasizing the enhancement of responsibility for evaluating and managing raw material suppliers. The proposed measures aim to accelerate the introduction of pharmaceuticals, ensure supply stability, and expand treatment opportunities for patients, all while efficiently managing manufacturing companies based on risk factors.

Currently, applicants for registration and approval of imported raw materials must submit extensive documentation and undergo on-site inspections. However, the MFDS plans to replace these requirements with a GMP certificate issued by relevant government agencies. This certificate must meet specified criteria, including compliance with PIC/S GMP or WHO GMP standards.

Manager Kim anticipates that these reforms will significantly reduce the registration period for raw materials to just 20 days, expediting GMP inspections for finished pharmaceutical product approvals. Additionally, the number of GMP documentation types required for pharmaceutical approval and compliance assessment will be reduced from 11 to four.

Furthermore, the MFDS aims to improve the criteria for determining the validity period of GMP compliance certificates. Instead of calculating from the end date of the inspection, the validity period will commence from the original expiration date, ensuring consistency and fairness.

Eun-hee Moon, Manager of the Pharmaceutical Management Division at MFDS, elaborated on plans for post-approval GMP evaluations. These evaluations will be expanded to include facilities deemed low-risk, allowing them to extend their GMP compliance without inspection under certain conditions.

The MFDS also announced the discontinuation of the Pre-Market GMP Reporting System, citing industry compliance with GMP standards. This decision follows two years of successful operation as a pilot project.

These regulatory improvements are expected to be implemented through legislative notice over the next four to six months, beginning in May 2024. Amendments to Prime Ministerial Decrees and notifications will be necessary to enact these changes.