[Press Release, Jun 26, 2020 / unofficial translation] Changes to be made in food and drug safety policies in the second half of 2020 □ The Ministry of Food and Drug Safety (Minister Lee Eui-Kyung) announced “Major changes to be made on food and drug policies in the second half of this year,” which are related to the safety management of food and medicine that directly affect the health of the people. < The government will raise the level of food safety, including the expansion of the application of HACCP. > ◈ Advance certification of HACCP for livestock products and mandatory HACCP certification for children's favorite foods ◈ Implementation of the National Residue Program (NRP) system for raw milk ◈ Introduction of non face-to-face on-site inspection system for imported food foreign manufacturers □ In order to improve the level of safety management of livestock products, livestock products processing business and eggs packaging business must obtain The Standards of Food Safety Management Accreditation (HACCP) certification before getting business license from October and have the certification renewed every three years. < Present > Businesses write and operate safety self-management standards ⇒ < Revised > Certification from the Food Safety Certification Board through paper and on-site examination; certificate should be renewed every three years ○ Starting in December, HACCP certification will be mandatory for eight foods*, including children's favorite foods, and GMP will be mandatory for all health functional foods**. * ①snack, candy ②bread, rice cake ③chocolates ④fish meat sausage ⑤drinks ⑥instant foods ⑦noodles ⑧special-purpose foods ** Obligation imposed by year based on sales: (2018) 2 billion or more → (2019) 1 billion or more → (2020) less than 1 billion won ○ Starting in July, the government will conduct tests on residues such as antibiotics and pesticides in raw milk which is an ingredient of dairy products such as milk in addition to those done by the civilian sector, and from December, countries exporting dairy products to Korea should submit the results of tests on antibiotics and other residues to the Korean government. * (Currently) The designated veterinarian (civilian belonging to the milk collection place) inspects → (Improvement) Additional inspections by the provincial and municipal testing agencies ○ In order to overcome the COVID-19 crisis and create a new food safety management environment, the government will make it mandatory for workers of food manufacturers to wear masks and for restaurants to have hand sanitizers. * Advance legislation notice for a revision of the 「Enforcement Rules of the Food Sanitation Act」 (June 4) - Expand the non face-to-face safety management system by converting on-site inspection of overseas manufacturing facilities of imported foods into document examination. < The government will support the rapid market release of innovative bio-health products. > ◈ Implementing a safety management system for advanced bio-medicine and innovative medical devices ◈ Full-fledged labeling medicines with all ingredients ◈ Operating the procedures for domestic use of medicines in clinical trials overseas □ In line with the implementation on August 28 of the 「Advanced Renewable Bio Act」, which strengthens the safety management of high-tech bio-medicine such as gene therapy drugs and supports fast commercialization, the government will establish a "management business for human cells" and implement a customized management system such as requiring long-term tracking of patients who are taking medication. * Advanced bio-medicine: Bio-pharmaceuticals manufactured from living cells, tissues or genes (cell therapy, gene therapy, tissue engineering drugs, etc.) ○ In the medical device sector, the 「Act for Developing the Medical Device Industry and Supporting Innovative Medical Device」 took effect on May 1. It will facilitate the implementation of new systems such as designating innovative medical devices and providing special privilege in permit and licensing, which will be able to provide greater therapeutic opportunities to patients. ○ Starting in July, it will be mandatory for manufacturers, importers, sellers, and leasers who supply medical devices to medical institutions and others to report the details of medical equipment supply through the integrated information system to ensure full-cycle safety management from licensing to distribution/use of medical devices. * Implementation time: Grade 4 (July 2020) → Grade 3 (July 2021) → Grade 2 (July 2022) → Grade 1 (July 2023) - A system will be established in November so that the history of implanted medical devices is traced from the time of delivery to the medical institutions and the time of use by the actual patients, and safety information such as side effects can be checked. ○ In order to satisfy the public's right to know and strengthen a transparency of information, the system* for labeling all medicine ingredients will be implemented in earnest from July, and the “generic medicine bundle** information” will be released gradually through the website of the Drug Safe Country from August to help the public easily understand it. * Labeling of all medicine ingredients: Marking the names of all ingredients listed on the item license (report) documents on the medication container or packaging. Operation of guidance period until June ** Drugs manufactured by the same manufacturer and sharing the bioequivalence test data ○ By operating the procedure* for allowing patients with terminal cancer or severe diseases who do not have treatment methods to take medicines being developed in foreign countries, the therapeutic opportunities for patients with rare and incurable diseases will be expanded. * Application to the Korea Rare and Essential Drug Center for the use and import of medicines in clinical trial overseas ○ The selection criteria will be worked out in September to further clarify which medicines should be subject to reevaluation of the safety and effectiveness at the current scientific level. ○ In December, “electronic license for medicine” will be introduced in place of paper license to reduce costs and improve convenience of reading - Starting in December, drug offenders should mandatorily take no more than 200 hours of rehabilitation education to lower the recidivism rate and increase the rate of return to normal social life. □ The Ministry of Food and Drug Safety stated that while continuing to put priority on the protection of the public health, it will keep putting efforts to institutional innovation by improving safety-related procedural regulations and supporting the rapid launch of high-tech products.