SOUTH KOREA Law and Practice Contributed by: Keum Nang Park, Eileen Jaiyoung Shin, Eunkyoung Lyu and Soo Yeon Park, Lee & Ko
3. Marketing Authorisations 3.1 Product Classification
apply to clinical trials, where the treatment for and monitoring of patients during clinical tests may be converted to untact treatment and monitoring. 2.5 Use of Data From Clinical Trials The data from clinical trials is considered personal and sensitive data and the institutions conducting clinical trials are subject to the Personal Information Protec- tion Act (PIPA) for the collection, use, provision, etc, of such personal and sensitive information. In addition, information with respect to the participant’s identity or sponsor’s intellectual property, etc, shall not be disclosed to third parties unless there is explicit per- mission granted to access that information. Further, in order to protect the clinical trial subjects’ identity, unique identity numbers need to be assigned to sub- jects instead of their name. When obtaining consent for the clinical trial from its subjects, the medical institution conducting the clini- cal trial must explain that the records of subjects’ personal information will be kept confidential, stipu- late the same in writing, and make it clear that such personal information shall be maintained confidential even if results of the clinical trial become publicly available. It further needs to state that the records relating to the clinical trial, including the subjects’ medical record, can be accessed by the sponsor’s monitoring agent or inspector through an institutional review board (IRB) of the medical institution, and that the MFDS may also access and review such informa- tion and relevant materials. 2.6 Personal or Sensitive Data In addition to the requirements described in 2.5 Use of Data From Clinical Trials , according to clinical trial management standards, such database needs to have a security system which prevents unauthorised per- sons from accessing the information, and matters as prescribed by the head of MFDS for proper manage- ment of electronic records must be complied with. The sponsor also has to use identifier code for clinical trial subjects.
Under Article 2 of the PAA, “drugs” are defined as those other than quasi-drugs, among the articles listed in the Korean Pharmacopoeia, or articles, other than appliances, machinery or equipment, used for the purposes of diagnosis, treatment, alleviation, care or prevention of diseases of human beings or animals, or used for the purpose of exerting pharmacological effects upon the structure or functions of humans or animals. A “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 diagnosing, cur- ing, alleviating, treating or preventing a disease; • a product used for the purpose of diagnosing, curing, alleviating or correcting an injury or impair- ment; • a product used for the purpose of testing, replac- ing or transforming a structure or function; and/or • a product used for the control of conception. With regard to medical devices, sometimes it is dif- ficult to distinguish medical devices from personal 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 a case, guidance or administrative interpretation from the MFDS may be requested. 3.2 Marketing Authorisation for Biologic Medicinal Products To market biological drugs in Korea, the initial market- er is required to obtain marketing authorisation in the same manner as that for chemical drugs. Key factors to consider when reviewing an application for market approval are: • data on origin or discovery and development pro- cess; • data on structure and physicochemical properties;
• data on stability; • toxicological data; • data on pharmacological mechanism;
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