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HOME > POLICIES > Becoming One of the World’s Top 7 Biohealth Nations > Fostering Growth of Pharmaceuticals and Medical Devices as Future Industries

Fostering Growth of Pharmaceuticals and Medical Devices as Future Industries

1. Fostering Pharmaceuticals, New Drug Discovery,etc.

Creating 2nd and 3rd Global Success Stories

  • Creating Conducive Environment for Corporate Investment
    • Full investment in‘Global Healthcare Fund’to financially support pharmaceutical companies in overseas clinical trials, M&A, open innovation, etc. (Feb ‘16-)

      * Support new investments in Global Healthcare Fund created in ’15 (KRW 150B)

    • Establishment of Clinical Trial Center within Advanced Medical Complex(’16-‘18), to achieve active integration with core support facilities such as Osong Drug Discovery Support Center (support for biomedicine development)and to strengthen ecosystem of support for companies

      * Planning cost of KRW 0.83B each for Osong and Daegu in ’16

    • Training on-site working professionalsthrough customizedGMP (Good Manufacturing Practice)education for yet-to-be employed individuals (Ministry of Industry)

      * Training 150 manufacturing professionals per year

  • Regulatory Reforms to Enable Swift Market Entry
    • Adding pharmaceuticals with marked improvements in safety and efficacy to expedited review group, and developing specific procedurefor the expedited review of treatment for rare and treatment resistant diseases (Jul ‘16, Ministry of Food and Drug Safety)

      * Expected reduction of 3 years in product development period for cancer treatment (10 years→ 7 years)

    • Preparation of preemptive guidelines for biomedicine (throughout the year) and collecting of regulatory information on biomedicine to support overseas market entry (Ministry of Food and Drug Safety)
      • - Presenting guidelines that adhere to international standards through the participation of domestic and international experts, reflecting latest trends in technology as well as industrial and medical demand

        *(‘15)Enactment, revision of eight documents including English Guide for Biosimilar Products → (’16) Enactment, revision of five documents including Clinical Trial Guide for Gene Therapy

      • - Providing comprehensive informationon regulatory information by country and market information,etc., through ‘Bio IT Platform’website (www.bpis.or.kr) (Sep)

        * Providing consultation on licensing to biomedicine companies wishing to enter international markets based on information on regulations, guidelines, and industries

      • Reduction of priority review application feefor research outcomes from companies in the Advanced Medical Complex (Mar ‘16, The Korean Intellectual Property Office)

        * Ex: Reduction of 70% for small and medium enterprises, 30% for enterprises of middle standing

  • Support for Development of Biomedicine Etc.
    • Developing evaluation standards for new drugs with global market potential, preferential evaluation of drug pricefor new drugs with global market potential developed by innovative pharmaceutical companies (Mar ‘16)
    • Preparing drug price calculation standardsfor biomedicine,reflecting drug characteristics, amount of improvement in clinical efficacy, research and development, etc. (Jun ‘16)

      * Working on revising standards for decisions and adjustments for pharmaceuticals (implementation in 2H ’16)

    • Application of routine care cost health insurance benefits to clinical trials with great public value,such as rare and resistant disease treatments(Oct ‘16)
    • Strengthening inter-ministry projects and focused R&D support for the continued growth of biohealth technologies in early stage development such asgene therapy, stem cell therapy, etc.

      * Government R&D investment for gene and stem cell therapy in ‘16 : Ministry of Welfare KRW 39.7B, Ministry of Future Planning KRW 50.5B

2. Development of Precision and Regenerative Medicine Industries

Fostering Precision and Regenerative Medicine as National Strategic Industries

  • Support Systems Including R&D,etc.
    • Focused support for R&D in genetic medicine for the customized treatment of diseases common among Koreans, including cancerand chronic, rare, and resistant diseases

      * Investment of KRW 36.08B in gene medicine R&D in ‘16 as part of “Post-genome Multi-ministry Gene Project” (Total of KRW 578.8B from ‘14 to ’21) (Ministry of Welfare, Ministry of Future Planning, Ministry of Industry)

    • Implementation of plan for doctor’s responsibility within hospital system for treatmentin advanced regenerative therapy (cell, gene, tissue engineering therapy) through Enactment of Act on Regenerative Medicine (bill submitted in Jun ‘16)
      • - Clinical application before Ministry of Food and Drug Safety approval allowedunder certain criteria to ensure safety

        * The EU has implemented a system to allow treatment to be administered under the doctor’s responsibility within the hospital before the approval of market release for advanced therapy medicinal products in ’07 (As of Sept ’12, 48 cases approved in six countries)

  • Building Core Infrastructure for Customized Medical Services
    • (Transition of unit-based biobanks implemented in scattered manner by separate institutions into large scale objective-based biobanks through individual disease networks*(Jan ‘16-)

      * DTC (Direct-To-Consumer) testing allows non-medical institutions to conduct testing directly for consumers without the referral of a medical institution (direct testing between non-medical institution and patient)

    • Expansion of genetic testing coverage within health insurance for the selection of targeted therapy, dosage, side effects prediction, etc. (Nov. ‘16)
      • - Expedited coverage for companion diagnosis technology in genetic testing, continued expansion of insurance coverage for genetic tests required for treatment selection and dosage determination

        * Expansion of testing for targeted therapy (16 types at present), additional testing for drug reaction prediction

3. Support for Advanced Medical Device Development

Expanding the Overseas Medical Device Market

  • Full Entry Into Chinese Market Through Korea-China FTA
    • Building local manufacturing complexesfor Korean medical device companies to work around customs barriersin export to China (2H ’16)

      * Establishing customized entry strategies based on investment environment research on candidate regions such as Weihai and Yantai

    • Expansion of joint procurement market participationby Korean companies through strengthened partnerships with Chinese local governments and related organizations (throughout the year)

      * Signing MOUs with governments and related organizations, holding exhibitions and business meetings participated in by Korean and Chinese companies as well as major buyers

  • On-site Focused Product Development
    • Support technology entrepreneurship of doctors/R&D for business development of technology. Combine with entrepreneurship training for doctors to create synergy (Ministry of Future Planning)
    • Expanded installation of mediating clinical support centers within hospitalsas centers for research collaboration among industry, academia, research institutions, and hospitals(6→7 centers)
      • - Create support system allowing clinical opinion to lead into product development in the entire process of medical device development

      * 1 additional center planned on top of currently existing Samsung Seoul Hospital (human implants), Korea University Guro Hospital (xenodiagnosis), Dankuk University Hospita (laser), Seoul National University Hospital (imaging diagnosis), Seoul National University Hospital of Dentistry (dental materials), Chonbuk National University (rehabilitation)

  • Supporting Development of Advanced, High Added Value Products
    • Working on development methods best suited to individual areas**withpriority on commercializationand expansion of investment*intoadvanced/highvalueaddedproductssuchasconvergent diagnosis/treatment devices (Ministries of Future Planning, Industry, Welfare)

      * Planned total investment of KRW 115.5B from the ministries involved (Ministry of Welfare, Ministry of Future Planning, Ministry of Industry) in medical device R&D

      ** (Ex) ICT convergent medical devices: participation of hospitals made compulsory, development focused on end user

      Healthcare apps: key competitiveness lies in ideas, support for converting ideas into products
    • Operation of joint support system for licensing over entire product lifecycle from initial stages of developmentfor fast market entry through cooperation between relevant ministries (Ministry of Food and Drug Safety)
      • - Selection of 20 new convergent products with potential for advance domination of global market to provide customized mentoring over entire lifecycle ([Next Generation Medical Device 100 Project])(Jan-)
      • * Integrated solutions for information, technology, and regulatory requirements at each product development stage (R&D, clinical trial, licensing, GMP) for R&D projects sponsored by the respective ministries

      • - Implementation of licensing in stagesto allow conducting of licensing review beforehand for each product development stage, leading to immediate licensing upon completion of product. (Dec)

        * Prioritized application to convergent medical devices with future potential such as electrical neural stimulation devices for alleviation of Alzheimer’s symptoms

Last Update : 2016.4.19

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