Biopharmaceutical Committee

Priority Issues

  1. Study and implementation of measures to secure and develop human resources for biopharmaceutical manufacturing and CMC
  2. Study to further promote development of biopharmaceutical seeds
  3. Study related to utilization of domestic manufacturing infrastructure and domestic single-use materials
  4. Investigation and research on matters to be included in applications for manufacturing and marketing approval of biopharmaceuticals
  5. Research and study on regulations and development of regenerative medicine, cell therapy, and gene therapy
  6. Efforts to address various issues related to vaccines

Priority Tasks to be addressed

Study and implementation of measures to secure and develop human resources for manufacturing and CMC of biopharmaceuticals. 3.

  1. Support for the development of human resources for biomanufacturing: Continue to implement practical educational programs using the manufacturing facilities of pharmaceutical companies.
  2. Support for education of future biomanufacturing human resources: Consider and provide educational opportunities for students in school to convey the appeal of biopharmaceutical manufacturing and CMC R&D.
  3. Human resource development function for new modalities: Continue to support human resource development in collaboration with the Biologics Research and Training Center (BCRET), 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.

Follow-up on global/regional bio-community activities and support for venture/start-up start-ups to close the gap between industry, government, and academia (an entrepreneur support system that can consult on various problems of entrepreneurs in a chatbot-like manner while utilizing AI), and promote concrete measures through co-creation activities with relevant stakeholders. Promote concrete measures through co-creation activities with relevant stakeholders.

3) Study on utilization of domestic manufacturing infrastructure and domestic single-use materials. 4) Study on approval of biopharmaceuticals for marketing authorization.

Examine issues and measures to utilize domestically manufactured and domestically produced single-use materials from the perspective of national security and economic security.

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

  1. Review of Common Technical Documents (CTD) for biopharmaceuticals and examples of how to describe them in applications for approval in consideration of Establish Condition (EC) (initial review of EC for manufacturing methods and specifications and test methods)
  2. Review 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 in the 2025 amendment of the Pharmaceutical Affairs Law (items to be described in the approval documents and 4 categories of changes).
  3. Study for preparation of "Draft Guideline for Quality Assurance of Exosome Preparations
    AMED research group will continue the study. 1.

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

  1. Cartagena Operational Improvement

    In collaboration with the AMED research group and the Pharmaceuticals and Medical Devices Agency (NIH), prepare materials that contribute to improving the quality of application materials for ministerial approval/confirmation and shortening the review period in relation to the Cartagena Act, and publish them on the PMDA website, etc.

  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 the MHLW, PMDA and industry (JPMA, Forum for Innovation in Regenerative Medicine (FIRM)). Cooperate in the preparation and issuance of notices, etc.

  3. Cooperation with administrative agencies related to regulations

    Participate in research on the use of RMPs in post-marketing safety measures for regenerative medicine products, research on the Cartagena Act Type 1 Use Regulations for the initiation of clinical trials for adeno-associated virus vectors (AAV), and the project to promote the practical application of gene therapy, and conduct activities to appropriately reflect industry opinions.

6. addressing issues related to vaccines

(1) Strengthen the foundation of the vaccine R&D, production and supply system

  • In preparation for the next contingency of infectious diseases, the committee will strengthen research and development capabilities for the creation of basic technologies, and study and make proposals on various measures that contribute to the establishment of a sustainable domestic production and supply system as a means to ensure a stable supply and supply of medicines in times of peace.
  • Based on the strategy for medicines for crisis management of infectious diseases (MCM), which is scheduled to be approved by the Cabinet in February 2026, efforts to ensure the effectiveness of long-term stable vaccine policies will be promoted.
  • From the viewpoint of improving predictability, clarify the procedures for the routine immunization of vaccines with high development priority and improve their effectiveness.

(2) Review of vaccine utilization to promote life course immunization

  • In anticipation of the digitalization of immunization administration from June 2026, consider measures to utilize data that will contribute to improving the convenience of vaccination for the public and the efficacy and safety of vaccines.
  • To improve the vaccine literacy of the public, promote efforts related to the dissemination and promotion of education on immunization 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

  • Promote the development of the next generation of vaccine R&D personnel by utilizing the Center for Advanced Research and Development Strategies (SCARDA) and the collaborative community of industry.
  • To collaborate with the measures promoted by the Biomedical Committee for the development of biomanufacturing human resources, leading to the development of vaccine manufacturing human resources.

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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