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Biologics

Review & Approval

Background

  • To develop advanced review and approval systems and actively respond to the global growth of the biopharmaceutical area and changes in the regulatory and medical environments
  • To provide government-level support to overcome global regulatory hurdles, in order to ensure the advance of biohealth and other promising industries into global markets
  • To lead global harmonization and international cooperation to ensure both safety and industrial development and to lead the way in "smart" and advanced regulations

Key activities

  • Operation of a rapid and predictable review and approval system, reasonable and scientific requirements and procedures for review and approval
    • Improved transparency in review and approval
    • Review and approval expertise
    • Improved operation of compendia
    • Implementation of an advanced review system
  • Services to support commercialization
  • Reinforced international cooperation and competitiveness
R&D
Development of scientific and international systems for quality, safety and efficacy assessments of biologics to ensure a system for the supply of safe and efficacious biologics
1 Safety control of biologics
  • Studies on the implementation of foundations for the safety and efficacy of vaccines and blood products and the development of technologies for assessment of such product
  • Studies on advanced and scientific production and quality control of emerging biological diagnostic products
  • Studies on quality standards of biologics
  • Studies on the preparation and establishment of national reference standards to ensure supply of safe biologics
2 Effectiveness assessment of vaccines
  • Clinical studies for monitoring of the safety and effectiveness of vaccines distributed in the local market
3 Safety control and assessment of advanced therapy products
  • Studies on the development of scientific systems for quality, safety and efficacy assessment of advanced therapy products
  • Studies on the standardization of quality specifications for advanced therapy products
  • Establishment of characterization and analytical procedures for advanced therapy products
  • ※ Advanced therapy products : recombinant protein products, cell therapy products, gene therapy products and others
4 International cooperatio
  • Establishment of a system for cooperation with international organizations, such as the World health organization (WHO), for the assessment of biologics
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