SOUTH KOREA Law and Practice Contributed by: Keum Nang Park, Eileen Jaiyoung Shin, Jeonghoon Hong and Soo Yeon Park, Lee & Ko
upon the structure or functions of humans or animals. “medical device” is defined under the MDA as an instrument, machine, apparatus, material, software or any other similar product specified in the following: • a product used for the purpose of diagnos- ing, curing, alleviating, treating or preventing a disease; • a product used for the purpose of diagnosing, curing, alleviating or correcting an injury or impairment; • a product used for the purpose of testing, replacing or transforming a structure or func- tion; and/or • a product used for the control of conception. With regard to medical devices, sometimes it is difficult to distinguish medical devices from per- sonal healthcare products (which do not require medical device approval) even when considering the purpose of use and the risk to the human body. In such case, guidance or administrative interpretation from the MFDS may be requested. 3.2 Granting a Marketing Authorisation for Biologic Medicinal Products To market biological drugs in Korea, the initial marketer is required to obtain marketing approv- al the same as that for chemical drugs. Key fac- tors to consider when reviewing an application for market approval are: • data on origin or discovery and development process; • data on structure and physicochemical prop- erties; • data on stability; • toxicological data; • data on pharmacological mechanism;
• data on clinical trial results; and • data on domestic and overseas usage and approval status. For some biologics such as the botulinum toxin, additional 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 market approval for biosimilars. On the other hand, cell therapy products (medi- cine manufactured by physical, chemical, or bio- logical manipulation, such as cultivation, prolif- eration, 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 tissues of humans or animals for the purpose of regen- erating, restoring or replacing tissues), advanced bio-convergence products (cell therapy prod- ucts, 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. (For those not regulated by AABP, PAA applies.) 3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices Under the PAA, marketing authorisation for phar- maceuticals 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 submit- ted to the MFDS at least six months before the
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