SOUTH KOREA Law and Practice Contributed by: Keum Nang Park, Eileen Jaiyoung Shin, Eunkyoung Lyu and Soo Yeon Park, Lee & Ko
• when attempting to use investigational drugs for research or analysis (referring to research or analy- sis not involving human subjects). In addition, certain orphan drugs and drugs for the treatment of rare diseases that are directly import- ed and distributed by the Korea Orphan & Essen- tial 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 authorisation. 3.6 Ongoing Obligations Imposed by Marketing Authorisations Effective as of 21 February 2025, the existing re- examination system for pharmaceuticals will be abol- ished, and the safety management system for phar- maceuticals will be integrated into a comprehensive Risk Management Plan (RMP) system. According to the PAA, those who wish to apply for marketing authorisation (or notification, as applicable) for new drugs, orphan drugs, advanced biopharma- ceuticals, already approved drugs, or prescription drugs with a different type or combination ratio of active ingredients, must establish and submit a com- prehensive drug safety management plan, known as the Risk Management Plan (RMP), which includes information on safety and efficacy, or other types of risk mitigation methods as applicable. Those who have received marketing authorisation must conduct risk management according to the RMP and regularly submit the relevant results to the MFDS. The MDA stipulates that the head of the MFDS may conduct safety and efficacy investigations for at least four years and no more than seven years on newly developed medical devices, orphan medical devices, and medical devices equivalent to newly developed medical devices. Approved pharmaceuticals or medical devices may be subject to re-evaluation if the MFDS finds it necessary to re-evaluate the safety and efficacy of the product. To re-evaluate, the MFDS reviews not only documents and materials submitted before obtaining the market- ing authorisation, but other post-approval information, including side-effect data since launch, status in other
countries and amendments to the marketing authori- sation made in relation to safety and efficacy. 3.7 Third-Party Access to Pending Applications for Marketing Authorisations Under the PAA and MDA, if the applicant files a request in writing to protect information or data con- tained in the application for marketing authorisation against disclosure, such information or data should not be disclosed unless otherwise required by the public interest. The PAA and MDA even impose crimi- nal penalties for breaching the non-disclosure obliga- tion above. Further, the Korean Criminal Act (KCA) punishes a public official or former public official who divulges secrets obtained in the course of performing their offi- cial duties. While the contents of the application are not dis- closed, third parties may infer from the following cir- cumstances that certain marketing authorisations may be granted shortly: • clinical trial approval status for drugs is pub- lished on the MFDS website; in particular, it can be inferred that generic drugs are scheduled to be released from the clinical trial approval status, since the submission of bioequivalence test results is required for approval of generic drugs; and • the MFDS publishes notices of DMF registration of APIs on its website. 4. Regulatory Reliance and Fast-Track Registration Routes 4.1 Fast-Track Registration Routes The expedited (priority) review of pharmaceuticals is primarily governed by the PAA, the Act on the Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals, and the Special Act on the Promotion of Development and Emergency Supply of Medical Products for Public Health Crisis Response. Under the PAA, the MFDS can designate a drug for priority review based on the applicant’s request if it
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