[Press Release, July 16, 2020 / Unofficial translation] K-Generic Drugs Moving Forward with Confidence and Competitiveness - 21 tasks derived from the public-private consultation on generic drugs - □ The Ministry of Food and Drug Safety (MFDS, Minister Lee Eui-kyung) announced the outcome of the "public-private consultative body for strengthening the international competitiveness of generic drugs" (hereinafter referred to as the public-private consultative body), which has been established and operated since May to enhance the competitiveness of Korean generic drugs. < Public-private consultative body for strengthening the international competitiveness of generic drugs > : A consultative body, consisting of experts from the pharmaceutical industry, pharmacist groups, academia, patient groups, consumer groups, and the MFDS officials, is designed to strengthen the competitiveness of generic drugs and promote the safe use of the drugs ○ The public-private consultative body mainly discussed the quality and safety management of generic drugs and how to strengthen their international competitiveness and devised future action plans for 21 detailed tasks in 4 areas (see Attachment): improving the quality reliability of generic drugs, further providing information, promoting product development, and supporting exports of K-generic drugs. □ The main tasks that the public-private consultative body agreed to pursue are as follows: < ①-1 Improving the quality reliability of generic drugs> ○ The following tasks will be implemented so that the quality of generic drugs approved and distributed in Korea is assured and recognized globally. ○ To ensure the distribution of generic drugs whose quality is assured, GMP compliance will be checked in advance before the approval even when the whole manufacturing process is outsourced. - By strengthening GMP data requirements, we plan to increase the quality accountability of trusters. [Before] The GMP data of the items manufactured through outsourcing was not submitted *Only the GMP data of the items actually manufactured by trustees are submitted [After] The GMP data of the items manufactured through outsourcing needs to be submitted *For approval, the GMP data of the items manufactured through outsourcing also needs to be submitted after the actual production of three manufacturing numbers. (However, if the item is the same as the trustee's item in terms of the manufacturing unit size and equipment, data of one manufacturing number can be submitted) ○ In addition, the results of onsite inspections will be disclosed on the MFDS website so that the public knows the management and operation status of pharmaceutical manufacturers. < ①-2 Enhancing proactive safety management such as changing the manufacturing method of generic drugs > ○ Changes in the "manufacturing method" that had been voluntarily managed by manufacturers, such as a post-approval change in detailed processes which can affect the quality and efficacy of drugs or in the particle size of raw materials, will now require pre-approval by differentiating the degree of changes according to impacts on quality and efficacy. ○ In order to maintain the equivalence of generic drugs, in the case of drugs with the same main ingredient and formulation but different contents (△△ Tablets 10mg, 20mg), - stricter standards will apply when the type and blending ratio of additives between products with different contents are different by requiring to prove equivalence through a "bioequivalence test" rather than a "comparative dissolution test." ○ In addition, the quality review of a finished drug used to be conducted after the registration of a drug substance (main ingredient), but the quality review of a drug substance will be conducted in parallel with the review of a finished drug to increase the efficiency of review for approval. - We will eliminate drug quality blind spots by proactively identifying risk factors such as drug substance impurities (NDMA, etc.) in the final stage of drug review. < ②-1 Development and provision of collective information on generic drugs> ○ We will develop “collective information on generic drugs”* and provide it for anyone to access through various methods such as the MFDS website or mobile web so that people can easily distinguish generic drugs from other medicines. < Collective information on generic drugs > - A list of generic drugs manufactured from the same manufacturer and approved based on the same equivalence test data - A list of collective information includes "product name," "company name," "pharmaceutical classification code (ATC code)," and "main ingredient code" and "product code" on the HIRA list of drugs covered by National Health Insurance. * (A rate of generic drugs manufactured through outsourcing) The rate of items manufactured through outsourcing increased from 49% (before 2012) to 85% (after 2012) as of 2012 when outsourced bioequivalence testing was allowed. ○ "Collective information on generic drugs" will be used for safety management (product development, approval review, quality control, retrieval/ disposal, etc.) and the safe use of all drugs in Korea. < ②-2 Expanding the provision of information > ○ Currently, only drugs with a single ingredient display the active ingredient in the product name, but drugs with complex ingredients will now have to indicate the active ingredients in the product name for easier identification of the products. [Before] Product name (ingredient name not included) / ABC Tablet [After] Product name (ingredient name included) / ABC Tablet (Rosuvastatin, amlodipine) ○ Currently, many of the same generic drugs that are produced through outsourced manufacturing by one company are recognized as different products. - In order to improve the above situation and provide precise information, we plan to include information about the manufacturer and equivalence on the packaging of the product. [Before] AA Tablet [After] AA Tablet (Manufacturer and equivalence information) < ②-3 Enhanced promotion of selection and use of generic drugs> ○ We will promote the use of generic drugs by raising awareness. ○ We will provide statistics on the drug approval management system and the results of bioequivalence testing as course materials for doctors and pharmacists training to increase the confidence and use among doctors and pharmacists. ○ Furthermore, we will continue to provide information through a participation in consumer groups' education programs, promotion on social media such as YouTube, and distribution of leaflets in an effort to improve consumers’ awareness and provide more information. < ③ Promoting development and use of products> ○ We will promote the development and the use of generic drugs by supporting companies preparing for the release of generic drugs through research and development, such as seeking a patent for an original drug. - Currently in many cases, there are no generic drug* in Korea even though the original drug patent has expired, so it is necessary to support the development by providing patent information. * Of the 463 items whose patent was expired, 239 items have no approval for generic drugs (as of Dec. 2019) ○ To this end, we will prepare customized approval guidelines for a product development and continue to analyze and disclose comprehensive information related to patent-approval for the development of products that do not have any registered patents or available generic drugs. ○ We will continue to provide patent consulting needed for the development and a launch of products for small and medium-sized pharmaceutical companies. ○ In order to increase the effectiveness of the "Primary Sales Item Approval" system, which guarantees the first generic drug developer that accelerated the entry into the market by successfully obtaining a patent for an original drug the opportunity to sell the product for nine months prior to other products (prohibition of the sales of other generic drugs), we plan to exclude items that received approval through outsourcing from the scope of Primary Sales Item Approval so that the actual first generic drug developers can receive the benefit. < ④ Enhancing the competitiveness of K-generic drugs and supporting the access of global market> ○ We will help Korean generic drugs go global with international competitiveness. ○ We plan to provide the incentive of expedited review to finished drugs that use domestic drug substances to promote the use of domestic ingredients with the aim to improve the added value of generic drugs. ○ We will also continue to pursue Mutual Recognition Agreements (MRAs) with major foreign countries to help Korean drugs enter the global market. ○ We will provide information by establishing an index database in English so that foreign drug buyers including pharmaceutical companies can conveniently check the status of Korean drug manufacturers by drug substances. □ The MFDS will effectively and actively carry out various action plans derived from the public-private consultative body. ○ "Collective information on generic drugs" will be disclosed in stages through the MFDS website from the end of August. ○ In the field of quality evaluation, 26 professional reviewers will be hired to prepare a database for quality review and collective information. ○ In the course of implementing action tasks, we will communicate closely with doctors, pharmacists, consumer groups, and experts in the pharmaceutical industry so that policies can be promoted smoothly. ○ We will establish a safe-use system and help strengthen the competitiveness by ensuring that the quality and efficacy of Korean generic drugs are on par with the original drugs. * Please refer to the attached file for more infornation such as statistics, illusteration and tables.