Biopharmaceutical Committee

Priority Issues

  1. Formulation and implementation of a specific human resource development plan for domestic biomanufacturing human resource development
  2. Study to further promote development of biopharmaceutical seeds
  3. Investigation and research on matters to be included in applications for manufacturing and marketing approval of biopharmaceuticals
  4. Research and study on regulations and development of regenerative medicine, cell therapy, and gene therapy
  5. Efforts to address various issues related to vaccines

Initiatives

Formulate and implement a concrete human resource development plan for domestic biomanufacturing human resource development. 2.

Continue the following initiatives as recommended in the Pharmaceutical Manufacturers Association of Japan policy proposal.

  • Support for the development of human resources with the skills for biomanufacturing: Study, propose, and implement practical educational programs and operational systems for human resources responsible for manufacturing at domestic contract manufacturing organizations (CMO)/contract manufacturing and development organizations (CDMO), etc., using the manufacturing facilities of pharmaceutical companies.
  • Educational support for future biomanufacturing personnel: Provide ongoing opportunities to convey the overall picture and attractiveness of biopharmaceutical manufacturing and CMC R&D to students in school as a catalyst for their interest.
  • Human resource development function for new modalities:: Through collaboration between the Biologics Research and Training Center (BCRET), a general incorporated association, and the Pharmaceutical Cooperative Association, support will be provided for human resource development by leveraging the strengths of each company to date for each modality.

2) Study to further promote development of biopharmaceutical seeds. 3) Study for marketing approval of biopharmaceuticals.

Study and promote specific measures for co-creation activities by industry, academia, and government, including follow-up of global/regional bio-community activities, as well as closing the gap between industry, academia, and government and supporting start-up activities.

Investigation and research on items to be included in manufacturing and marketing authorization applications for biopharmaceuticals. 4.

  1. Study of Common Technical Documents (CTD) for biopharmaceuticals and examples of how to describe them in the application for approval in consideration of Establish Condition (EC) (initial study of EC for manufacturing methods and specifications and test methods)
  2. Examination of items subject to notification of minor changes in specifications and test methods
    Continue the study by the AMED research group in consideration of the regulatory changes (items to be described in approval documents and four categories of changes) discussed by the "Study Group on the Drug Regulations to Enhance Drug Discovery Capability and Ensure Stable Supply, etc.
  3. Study for preparation of "Draft Guideline for Quality Assurance of Exosome Preparation" AMED study group will continue the study. 1.

4. research and study on regulations and development of regenerative medicine, cell therapy, and gene therapy

  1. Cartagena Operational Improvement

    In cooperation with the research group of the Japan Agency for Medical Research and Development (AMED) and the Pharmaceuticals and Medical Devices Agency (PMDA), prepare materials that contribute to improving the quality of application materials for ministerial approval/confirmation and shortening the review period with regard to the Cartagena Act, and post them on the PMDA website.

  2. Study Council on Various Issues of Regenerative Medicine Products

    Monthly discussions on various issues related to the regulation of regenerative medicine products at the working level between MHLW, PMDA and industry (Pharmaceutical Manufacturers Association of Japan, Forum for Innovation in Regenerative Medicine (FIRM), and Medical Technology Association of Japan (MT-JAPAN)). Cooperation in issuing notices, etc.

  3. Cooperation with administrative agencies related to regulations
  4. (e.g., RMP guidelines review meeting for regenerative medicine products, research contributing to updating standards for biologically-derived raw materials for new modality pharmaceuticals, etc., project to promote infrastructure for practical use of gene therapy, etc.)

5. efforts to address issues related to vaccines

1）Improvement of market predictability to promote the establishment of vaccine R&D and manufacturing systems

  • Promote early improvement of the process of considering routine vaccination of vaccines with high development priority and improve predictability.
  • To sustain and strengthen the foundation of the vaccine industry, support for capital investment that contributes to stable supply and productivity improvement, and consideration of a government stockpile and purchase system for vaccines should be promoted.

(2) Review of the utilization of vaccines in Japan to promote lifelong immunization

  • Promote discussions among industry, academia, and government on the ideal immunization system so that the public can utilize innovative vaccines to maintain their health.
  • To improve the vaccine literacy of the public, exchange of opinions with related parties and media forums will be planned and held with a view to deregulation of advertising and other forms of communication of information on vaccines and infectious diseases.

(3) Establishment of regulations and standards for vaccine R&D, manufacturing, quality control, etc.

Promote ongoing public-private dialogue with MHLW, JIHS, and PMDA through the Vaccine Quadripartite Consultation.

4) Human resource development for vaccine R&D and stable supply

  • Utilize the Center for Advanced Research and Development Strategies (SCARDA) and the industry's collaborative community to develop human resources for next-generation vaccine research.
  • Promote and collaborate on measures to develop human resources for biomanufacturing promoted as the Biomedical Committee, leading to the development of human resources for vaccine manufacturing.

5）Promotion of vaccine policy in peacetime and emergency situations in cooperation with the IFPMA Vaccines Committee

Continue to collect international vaccination-related information and promote measures against infectious diseases.

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