SOUTH KOREA Law and Practice Contributed by: Keum Nang Park, Eileen Jaiyoung Shin, Eunkyoung Lyu and Soo Yeon Park, Lee & Ko
prescription drugs require a prescription from physi- cians, OTC drugs can be supplied to consumers with- out a prescription. Additionally, the MOHW has desig- nated certain OTC drugs as emergency drugs to treat light symptoms in urgent situations at patients’ dis- cretion, and such OTC drugs may be sold at 24-hour convenience stores by non-pharmacists after such stores’ registration with the local government. Medical devices are classified into Classes I to IV based on their intended use and the risk level asso - ciated with the device. Class I devices present the lowest risk, while Class IV devices are considered the highest risk and are subject to the greatest scrutiny. The Digital Medical Product Act, which governs digital medical devices, digital integrated drugs, and digi- tal medical/healthcare support devices, categorises these products into three distinct groups: digital medi- cal devices, digital integrated drugs, and digital medi- cal/healthcare support devices. This allows the MFDS to classify digital medical products into different tiers depending on their purpose, function, and potential risk, among other factors. The PAA, the MDA, the Bioethics and Safety Act (BSA) and relevant regulations govern clinical trials of medicinal products and medical devices, and the MFDS oversees approval for clinical trials. 2.2 Securing Authorisation to Undertake a Clinical Trial To conduct a clinical trial, the relevant clinical trial pro- tocol must be reviewed and approved by an institu- tional review board (IRB) of the MFDS. The materials required to be submitted by the applicant for clinical trial approval include the following: • for medicinal products, the clinical trial protocol, development plan, investigator’s brochure, material on manufacturing and quality of the investigational drug, preclinical trial data, materials on medical institution conducting the clinical trial, institute ana- lysing the clinical trial sample, and the investigator 2. Clinical Trials 2.1 Regulation of Clinical Trials
and Contract Research Organisation (CRO), poli- cies and forms regarding the clinical trial subjects, etc; and • for medical devices, the clinical trial protocol, materials proving that the clinical trial medical device is being manufactured in accordance with the facility, manufacturing and quality management system standards, purpose of use, working princi- ple and technical documents to verify performance and safety. Once approved, clinical trials must be conducted in accordance with the protocol and standards regard- ing good clinical practice for medicinal products and medical devices, as applicable. 2.3 Public Availability of the Conduct of a Clinical Trial All approved clinical trials are disclosed by the MFDS. Basic information regarding clinical trials such as sponsor information, information on the clinical trial including its title, purpose and use, information on the drug used, plan for clinical trial, method for assigning participants to an experimental or control group, the status of the clinical trial (eg, on-going, completed), method to administer and evaluate the clinical test (eg, primary and secondary end point), and subject inclusion and exclusion criteria can be searched at the medicinal products comprehensive information system, which is a website of the MFDS. 2.4 Use of Online Tools to Support Clinical Trials No restriction exists on using online tools to support clinical trials. However, it is generally required that clinical trials be conducted by doctors or hospitals with in-person interviews, and written informed con- sents from clinical trial subjects. Recruitment of clini- cal trial subjects can be conducted online. When a crisis alert level of serious magnitude or high- er is declared, and if deemed necessary to protect patients, medical personnel, and medical institutions from the risk of infection, the protocols allowing pro- visional “untact” medical care (a term coined by a research team in Korea for non-face-to-face contact) under Article 49–3 of the Infectious Disease Control and Prevention Act may be implemented. This may
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