[Press Release, Aug. 18 / Unofficial translation] Reform of an Approval and Review System of the MFDS Medical Products - Strengthening the expertise of approval/review system and supporting a swift commercialization… Securing Korean public health - □ The Ministry of Food and Drug Safety (MFDS, Minister Lee Eui-Kyung) and the Ministry of the Interior and Safety (MOIS, Minister Chin Young) reform an approval and review system of medical products to guarantee Korean citizen’s right for life and strengthen global competitiveness through advancing an expertise in the approval and review process as well as supporting a swift commercialization. ○Through the system reform, the approval process will be carried out by an affiliated division of the Vice Minister of the MFDS instead of National Institute of Food and Drug Safety Evaluation (NIFDS), but the review process will be continuously done by the NIFDS. □ The detailed information of “the reform of an approval and review system of medical products” is as follows: ○ In terms of the approval process, “Director for Approval Management” and “Director for Novel Products Approval” will be newly established and operated under the Vice Minister of the MFDS. - Meanwhile, the review process will be continuously done by the NIFDS; and “Pre-submission Consultation Division” and “Expedited Review Division” will be newly established and operated under the NIFDS Director General. ○ Director for Approval Management is generally in charge of improving the approval and review system of medical products including herbal medicines. On the other hand, Director for Novel Products Approval is in charge of approval of combination medical products, bio-pharmaceutical products (including quasi-drug products), and medical devices. ○ Pre-submission Consultation Division is in charge of providing consultation on the clinical trial protocol and approval of pharmaceuticals, medical devices, and new drugs that are subject to an expedited review. Meanwhile, Expedited Review Division reviews the data on designated registration for the expedited review of pharmaceuticals, medical devices and new drugs. *Products subject to an expedited review: Products such as crisis preventive pharmaceuticals, innovative new drugs, and innovative medical devices which have contributed to treating life-threatening diseases, new infectious diseases using digital-based medical devices and responding to the public health emergency situation. ○ Under the recently enacted Advanced Regenerative Bio Act and Medical Device Industry Act, the Ministry will advance expertise in various fields of advanced technology and implement customized reviewing system to manage new works such as the approval/review of novel bio-pharmaceuticals and innovative medical devices (software), and the review of high-risk clinical research plans on advanced regenerative medical services. ○ Amid rapidly changing era, the reform will increase the connectivity of policies under the comprehensive review of approval/review system, which is expected to establish specialized review system for high-quality/expedited review of new medical products that meet the 4th industrial revolution era and bio-health trend. □ Through the reform of the approval/review system, the MOIS will make reasonable policies based on scientific evidence for the approval process and conduct consultations from the stage of research and development for the review process, ○ and the MOIS stated that a expedited review of innovative treatments will shorten the commercialization period of pharmaceuticals, expanding the treatment opportunity for patients and contributing to a swift response to the public health emergency situation. □ The MFDS can strengthen the function of the Ministry’s policy related with the approval process and maintain the NIFDS’s reviewing expertise, ○ and the Ministry also stated that it will work hard to prioritize on protecting Korean citizens’ life and ensuring safety by dramatically reducing the review period on treatments for life-threatening diseases, crisis preventive pharmaceuticals (a vaccine for new infectious diseases, etc.) and innovative new drugs while strengthening the global competitiveness of Korean pharmaceutical industry. ※ Attachment (only in Korean) 1. Changes after the reform of an approval/review system 2. Work that will be done by newly established divisions 3. Organization structure after the reform