[ Press Release, April 3, 2020 / unofficial translation ] Establishment of Comprehensive Plans for Drug Safety Management (2020-2024) to Guarantee Healthy Living for the Public ▲Accelerating development of innovative new drugs ▲Expanding treatment opportunities for patients ▲Strengthening approval/examination expertise □ The Ministry of Food and Drug Safety (Minister Lee Eui-Kyung) has established a “1st-stage Comprehensive Plan for Drug Safety Management” so that the public can enjoy healthier lives by creating an environment for the safe use of drugs through whole-life-cycle safety management innovation and establishing a smart safety management system. ○ This 5-year plan(2020-2024) was established by the MFDS in collaboration with related central administrative agencies on the basis of Article 83-4 of the PHARMACEUTICAL AFFAIRS ACT, and was devised to: ?Make preemptive response to changes in the drug usage environment, ?Establish a global system for safety management, and ?Enhance the reliability and competitiveness of the domestic pharmaceutical industry. □ This plan consists of 5-pronged strategy and 32 detailed tasks with the vision of “guaranteeing public health through safe drugs.” [5-pronged Strategy] ① Creating an ecosystem for the development of innovate new drugs based on advanced technology ② Reforming safety management methods from drug development to the consumer ③ Expanding treatment opportunities and patient-centered policy ④ Strengthening expertise and creating safe usage environment through communication with the public ⑤ Expanding international cooperation and supporting innovate growth of the pharmaceutical industry which is a promising sector. □ The details of the 5-pronged strategy are as described below. [1] The MFDS will create an ecosystem for the development of innovative new drugs based on advanced technology and accelerate the development and commercialization of advanced biopharmaceuticals/hybrid medical devices. ○ To this end, the MFDS will ?prepare expedited approval procedures and an approval/examination system1) taking into account the characteristics of advanced biopharmaceuticals, ?support the development of new drugs for rare diseases using precision medicine2), and ?develop the evaluation technology on safety/efficacy utilizing innovative technologies (big data, AI, simulation, long-term models, etc.) 1) The introduction of special examination/cross examination (2020), expansion of document requirements for the approval of cellular/gene therapy. (2020) 2) Precision medicine: optimal medicine with increased effectiveness and decreased side effects by personalizing it through the integration/analysis of health-related information such as an individual’s medical history, genetic information, and lifestyle. [2] The MFDS will enhance the reliability of drug safety management by ensuring safety management throughout the whole life-cycle and reforming management method from drug development to consumption. ○ To this end, the MFDS will ?implement a consumer-centric drug approval system including preliminary examination program, ?reform impurity management system by moving from follow-up actions based on information from abroad to a preemptive response system1) aimed at enhancing quality/safety management competencies of the industry, and ?create a database of information on foreign establishments and perform risk-based evaluation/management. 1) Evaluation/analysis of potential impurity (2020), operation of a consultative group of impurity evaluation experts (2020) [3] The MFDS will improve access to drugs and expand treatment opportunities with inclusive and active policy focused on patients. ○ To this end, the MFDS will ?introduce/expand the operation of a Human Research Protect Program1) (HRPP) to strengthen the quality/ethics of clinical trials, ?implement a post-marketing patient safety system2) including patient registration/long-term follow-up management for advanced biopharmaceuticals, and ?advance clinical regulations3) to expand treatment opportunities. 1) HRPP (Human Research Protect Program): comprehensive, inclusive policy and activities implemented by institutions performing clinical trials to improve the quality of the trials and strengthen clinical ethics. 2) Establish of national follow-up management system for patients who have received the medication (2020), implementation of integrated network for long-term follow-up investigation of drug administering-base hospitals (2021-2023) 3) Simplify document requirements when approvals are needed to be authorized for treatment purposes (5 dossiers→4 dossiers), support new-concept drug clinical trials, such as precision medicine, etc. (2021), expand targets of clinical trial when the plans were changed and notified (from 2020) [4] The MFDS will create a safe environment for drug consumption by communicating with the public and strengthen expertise on drug approval/examination. ○ To this end, the MFDS will ?collaborate with the Korea Customs Service1) to deal with illegal counterfeit medications preemptively, ?reinforce the compensation system2) for drug side effects, ?provide more information3) necessary for the proper use of drug, and strengthen competencies and expertise in the drug approval/examination and quality management areas4). 1) Implement a system connected with illegal drug information and Korea Customs Service clearance risk management system (2020) 2) Shorten damage relief processing period (from 2020), Prepare procedures for non-payment determination objections (from 2020) 3) Provide cautionary information for drugs frequently used by the elderly (2020), Expanding provision of information on the proper usage of drugs for specific ailments (2022) 4) Prepare training system according to level of competency for each area/stage of experience (from 2021) [5] The MFDS will support innovative growth of the pharmaceutical industry by advancing regulations to a global level and expanding international cooperation. ○ To this end, the MFDS will ?expand smart factory technology based on IoT, ?maintain mutual recognition of testing reliability through OECD site evaluation related to good laboratory practices (GLP), ?strengthen cooperation by systematizing information-sharing at an MOU level, for promoting understanding between organizations, as confidential information sharing agreements (MOC). 1) Developing/supplying drug quality advancement system (QbD, Quality by Design) example models (2020-2021), operating customized consulting and professional personnel cultivation program to expand QbD application (from 2020) □ The MFDS, as a drug safety management control tower, will implement and systematically propel a mid/long-term drug safety management system taking into account changes in the societal/technical environment, and thereby create a safer environment for drug consumption so that the public can enjoy a healthy life. ○ Furthermore, the MFDS plans to consult with related institutions and prepare detailed plans for each year to facilitate the achievements of 32 detailed tasks associated with the comprehensive plan. ○ The comprehensive plan is available on the MFDS website: (www.mfds.go.kr) → Law/Documentation → Documentation Center → Manuals/Guidelines (only in Korean) Please find the attached file for more information