In the new year, the barriers to face-to-face consultation with drug approval examiners, which have been a hardship for new drug development corporations, are expected to be lowered compared to before. On-site inspections, which drug manufacturing firms had to undergo every three years, can now be extended by two years through written investigations. The number of documents corporations need to submit will be streamlined from 11 types to 4.
The Ministry of Food and Drug Safety introduced the changes to the drug approval and management system that will take effect in January 2025 on the 31st.
Starting next year, the Ministry of Food and Drug Safety will implement the "new drug approval and review innovation process." This process consists of three main stages. Upon receiving an application for new drug approval, a dedicated team will be formed for each product. The face-to-face consultation and review between corporations and approval examiners will be expanded from a maximum of "3 times" to a maximum of "more than 10 times," and the results will be communicated in writing. Additionally, the evaluation of Good Manufacturing Practice (GMP) for new drug manufacturing sites and a status survey will be conducted within 90 days of receiving the approval application.
However, to support this, the fee for applying for new drug approval that corporations must pay has increased. Starting from applications submitted on January 1, the new drug approval fee will be 410 million won.
The Ministry of Food and Drug Safety noted that "the approval process will be completed within 295 days from the application of new drug approval to the issuance of the approval certificate" and that "this is expected to support the rapid commercialization of new drugs."
The evaluation standards for drug manufacturing and quality control will also be revised. Starting from complaints submitted on the 30th of this month, the evaluation for compliance with Good Manufacturing Practice (GMP) during the registration of imported raw pharmaceuticals will be replaced with verification of a GMP certificate proving compliance with "WHO/PICS GMP standards," and the processing time will be significantly reduced from the current 120 days to 20 days. Furthermore, the documents required for GMP evaluation during drug approval applications will be consolidated and adjusted from the existing 11 types to 4. Regular inspections of low-risk drug manufacturing sites will be conducted through written investigations.
Although drug manufacturing sites that receive GMP compliance certification are generally required to undergo on-site inspections every three years, in cases where there are no significant changes based on prior evaluation results, such as low risk, they can extend their GMP compliance status by two years through written investigations without an on-site inspection. After the two-year extension, an on-site inspection will be conducted. Additionally, the criteria for calculating the extension validity period of the GMP compliance certificate will be revised from "3 years from the completion of the audit" to "3 years from the day after the expiration date of the existing validity period," thereby ensuring full protection of the 3-year validity period. The Ministry of Food and Drug Safety plans to conduct an industry briefing in the first half of the coming year regarding specific measures to be implemented outside of on-site inspections and written surveys, aiming for implementation in the second half.
The Ministry of Food and Drug Safety expressed hope that "the new systems being implemented in 2025 will contribute to public health and the development of the pharmaceutical industry" and stated that "moving forward, we will prioritize public safety as the highest value and plan to operate the drug approval and management system rationally in accordance with changes in the policy environment."