SOUTH KOREA Law and Practice Contributed by: Keum Nang Park, Eileen Jaiyoung Shin, Jeonghoon Hong and Soo Yeon Park, Lee & Ko
expiration date. If the marketing authorisation holder does not file the application for renewal or fails to meet the requirements, the marketing authorisation is cancelled. In the case of medical devices, no renewal sys- tem existed previously, but since 8 October 2020, marketing authorisation for medical devic- es is to be valid for five years from the marketing authorisation date. Similar to pharmaceuticals, for medical devices, data proving that safety and efficacy has continued to be the same since the initial issuance of the marketing authorisation, and data on production/import performance, etc, must be submitted for renewal at least 180 days before the expiration date. 3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices Data proving safety and efficacy, such as clini- cal trial results, must be submitted to the MFDS for obtaining marketing authorisation. In some cases, such as generic drugs or incrementally modified drugs, however, safety and efficacy data can be replaced with bioequivalence test result data. The procedure for assessing marketing authori- sation on medical devices varies depending on the risk they pose to human bodies. In the case of high-risk medical devices (Class III/IV), a high- er level of scrutiny will apply, such as requesting and reviewing more data, including clinical data proving the efficacy and safety, compared to low-risk medical devices (Class I/II) where vari- ous data such as clinical trial data is exempted. In the event that the indications for drugs or medical devices are changed after marketing authorisation, it is possible to file an approval
for change, and the procedure is similar to the procedure for new marketing authorisations. It is also possible to transfer a market approval from one market approval holder to another. 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations In Korea, even if no marketing authorisation has been obtained, investigational drugs can, after relevant clinical trials are implemented and approved, be used as part of a compassionate use programme. The compassionate use pro- gramme is permitted only in the following cases: • when treating patients with life-threatening conditions such as an end-stage cancer or acquired immunodeficiency syndrome (AIDS); • when treating emergency patients, such as those in a critical condition or for whom there are no alternative treatment options; and • when attempting to use investigational drugs for research or analysis (referring to research or analysis not involving human subjects). In addition, certain orphan drugs and drugs for the treatment of rare diseases that are directly imported and distributed by the Korea Orphan & Essential Drug Center (KOEDC), as well as drugs that the MFDS admits for urgent introduction for the treatment of patients, are exempted from the requirement for obtaining marketing authorisa- tion. 3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations Effective as of 21 February 2025, the existing re-examination system for pharmaceuticals will be abolished, and the safety management sys- tem for pharmaceuticals will be integrated into
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