SOUTH KOREA Law and Practice Contributed by: Keum Nang Park, Eileen Jaiyoung Shin, Jeonghoon Hong and Soo Yeon Park, Lee & Ko
a comprehensive Risk Management Plan (RMP) system. According to the PAA, those who wish to apply for market approval (or notification, as appli- cable) for new drugs, orphan drugs, advanced biopharmaceuticals, already approved drugs, or prescription drugs with a different type or combi- nation ratio of active ingredients, must establish and submit a comprehensive drug safety man- agement plan, known as the Risk Management Plan (RMP), which includes items for which infor- mation on safety and efficacy needs to be col- lected, or other types of risk mitigation methods as applicable. Those who have received mar- ket approval must conduct risk management according to the RMP and regularly submit the relevant results to the MFDS. The MDA stipulates that the head of the MFDS may conduct safety and efficacy investigations for at least four years and no more than seven years on newly developed medical devices, orphan medical devices, and medical devices equivalent to newly developed medical devices. Approved pharmaceuticals or medical devices may be subject to re-evaluation if the MFDS finds it necessary to re-evaluate the safety and efficacy of the product. To re-evaluate, the MFDS reviews not only documents and materials sub- mitted before the marketing authorisation, but other post-approval information, including side- effect data since launch, status in other coun- tries and amendments to the marketing authori- sation made in relation to safety and efficacy. 3.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices Under the PAA and MDA, if the applicant files a request in writing to protect information or
data contained in the application for marketing authorisation against disclosure, such informa- tion or data should not be disclosed unless oth- erwise required by the public interest. The PAA and MDA even impose criminal penalties for breaching the non-disclosure obligation above. Further, the Korean Criminal Act (KCA) punish- es a public official or former public official who divulges secrets obtained in the course of per- forming their official duties. While the contents of the application are not dis- closed, third parties may infer from the following circumstances that certain marketing authorisa- tions may be granted shortly: • clinical trial approval status for drugs is published on the MFDS website; in particu- lar, it can be inferred that generic drugs are scheduled to be released from the clinical trial approval status, since the submission of bioequivalence test results is required for approval of generic drugs; and • the MFDS notices the DMF registration of APIs on its website. 4. Regulatory Reliance and Fast Track Registration Routes 4.1 Fast Track Registration Routes The expedited (priority) review of pharmaceuti- cals is primarily governed by the PAA, the Act on the Safety and Support for Advanced Regen- erative Medicine and Advanced Biopharmaceu- ticals, and the Special Act on the Promotion of Development and Emergency Supply of Medical Products for Public Health Crisis Response. Under the PAA, the MFDS can designate a drug for priority review based on the applicant’s
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