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Opinion
[Reporter's View] GMP standards for sterile products
by Lee, Hye-Kyung Jun 17, 2025 05:58am
The Ministry of Food and Drug Safety (MFDS) is devising measures to reduce the burden on the pharmaceutical industry ahead of the implementation of the 'Revised PIC/S Good Manufacturing Practices (GMP) Guide for Sterile Medicinal Products (guidelines on manufacturing and quality control of medicines)' in December. Following the administrative announcement of revised guidelines in 2023, the MFDS has granted a two-year grace period. Therefore, the MFDS has planned a solution to lessen the burden, rather than an extended grace period as requested by several pharmaceutical companies. Strengthened GMP standards for sterile medicinal products include ▲systemic establishment·implementation of contaminant management methods for sterile medicinal products ▲establishment of separate GMP for cutting-edge technology biotechnology medicines ▲specifying detailed formulation and selection process·methods for products meeting GMP standards. Establishing contamination-control strategies is most important, but establishing a strategy for each lot number requires substantial manpower and investment. Approximately 100 companies in South Korea are reportedly manufacturing sterile products. In fact, since late last year, news of sterile production halts has been circulating, primarily among some manufacturers. For instance, Ildong Pharmaceutical's 'Ativan,' which had experienced years of supply halt and re-production, recently announced a final halt to both supply and production. According to the MFDS, this is due to the company's internal circumstances. It is also rumored that the decision to withdraw was made due to a combination of existing supply concerns, such as the cost-effectiveness of reinvesting in facilities, given the strengthened GMP standards. MFDS's consistent response when asked has been 'no further grace period.' Then, on the 11th, the MFDS Quality Management Division proactively requested a meeting with reporters. The MFDS explained that they had met with factory managers from approximately 20 manufacturers of sterile products last month. The reason they couldn't hold a press briefing immediately was their desire to jointly explain the ongoing 'Research on the GMP Guide for Sterile Products Implementation Plan' with the Korea Pharmaceutical and Bio-Pharma Manufacturers Association. MFDS has been conducting research jointly with the association since last year to alleviate the industry's burden related to the strengthened management of GMP for sterile products, aiming for standard relaxation. They are already in the mid-phase of research with three companies, HK inno.N, JW Pharmaceutical, and Daehan Pharmaceutical, which produce over 90% of large-volume intravenous fluids. If this research is successful, standards for large-volume intravenous fluids are expected to be relaxed first. From a quality perspective, they were preparing technical support measures to alleviate the industry's burden resulting from the actual implementation of the strengthened standard. However, a question arises here. While technical and regulatory support measures are being prepared to apply GMP standards at the same level as PIC/S member countries to domestic sterile product preparation manufacturers, has an alternative plan been prepared for cases where smaller companies, facing difficulties in facility and personnel investment despite this support, decide to abandon sterile product preparations? The disappointing part was the Quality Management Division's ambiguous response, suggesting that the Biopharmaceutical Management Support Team might handle supply-related issues rather than the Quality Management Division. It sounded like, 'GMP standards are our division's responsibility, but supply is another division's responsibility, so we don't know.' MFDS expresses concern that it might appear as if companies are abandoning the supply of sterile products, such as injectables, solely due to the strengthening of GMP standards. However, these two issues are inseparable. Many sterile product preparations are designated as shortage prevention drugs (SPD) or national essential medicines. This designation implies that the government intends to manage them because they are not profitable. Now, a situation has arisen where companies must invest anywhere from several billion to tens of billions of KRW in facilities and manpower for sterile product preparations that yield almost no profit. Consequently, it's inevitable that cases will emerge where companies decide to withdraw products after weighing investment costs against profitability. Therefore, instead of considering the issues of standards and supply separately, we hope that they will be addressed together, and solutions will be devised to reduce the burden on the pharmaceutical industry and alleviate public anxiety caused by supply instability.