SOUTH KOREA Law and Practice Contributed by: Keum Nang Park, Eileen Jaiyoung Shin, Eunkyoung Lyu and Soo Yeon Park, Lee & Ko
• data on clinical trial results; and • data on domestic and overseas usage and approv- al status. For some biologics such as the botulinum toxin, addi- tional strict requirements on use, transfer, etc, apply. Meanwhile, unlike generic drugs, a bioequivalence test does not replace data on stability and efficacy in order to obtain marketing authorisation for biosimilars. On the other hand, cell therapy products (medicine manufactured by physical, chemical, or biological manipulation, such as cultivation, proliferation, or screening of living cells of humans or animals in vitro), gene therapy products (medicine containing genetic material or drug-containing cells into which genetic material has been modified or introduced), tissue- engineered products (medicine manufactured by applying engineering technology to living cells or tis- sues of humans or animals for the purpose of regen- erating, restoring or replacing tissues), advanced bio-convergence products (cell therapy products, gene therapy products, tissue engineered products, and medicinal products formed through physical and chemical combination (including fusion, complex, combination) with medical devices under the MDA) are regulated by AABP, and marketing authorisation must be obtained accordingly. Note that, for those not regulated by AABP, PAA applies. 3.3 Period of Validity of Marketing Authorisations Under the PAA, marketing authorisation for pharma- ceuticals is valid for five years, and renewal is required after five years. For renewal, safety data, domestic manufacturing/import data, and a GMP compliance certificate must be submitted to the MFDS at least six months before the expiration date. If the marketing authorisation holder does not file the application for renewal or fails to meet the requirements, the market- ing authorisation is cancelled. In the case of medical devices, no renewal system existed previously, but since 8 October 2020, mar- keting authorisation for medical devices is to be valid for five years from the marketing authorisation date. Similar to pharmaceuticals, for medical devices, data proving that safety and efficacy have continued to be
the same since the initial issuance of the marketing authorisation, and data on production/import perfor- mance, etc, must be submitted for renewal at least 180 days before the expiration date. 3.4 Procedure for Obtaining a Marketing Authorisation Data proving safety and efficacy, such as clinical trial results, must be submitted to the MFDS for obtain- ing marketing authorisation. In some cases, such as generic drugs or incrementally modified drugs, how- ever, safety and efficacy data can be replaced with bioequivalence test result data. The procedure for assessing marketing authorisa- tion 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 higher level of scru- tiny 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 various 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 pro- cedure is similar to the procedure for new marketing authorisations. It is also possible to transfer a marketing authorisation from one marketing authorisation 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 clin- ical trials are implemented and approved, be used as part of a compassionate use programme. The com- passionate use programme is permitted only in the following cases: • when treating patients with life-threatening condi- tions 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 alter- native treatment options; and
309 CHAMBERS.COM
Powered by FlippingBook