Biopharmaceutical Committee

Priority Issues

  1. Examination and Implementation of Measures Regarding the Recruitment and Training of Personnel for Biopharmaceutical Manufacturing and CMC
  2. Discussions to Further Promote the Development of Biopharmaceutical Leads
  3. Studies on the Utilization of Domestic Manufacturing Infrastructure and Domestically Produced Single-Use Materials
  4. Research and Study on the Information Required in Applications for Marketing Authorization of Biopharmaceuticals
  5. Research and studies on regulations and development related to regenerative medicine, cell therapy, and gene therapy
  6. Addressing Various Issues Related to Vaccines

Initiatives Addressing Priority Issues

1. Discussions and implementation of measures regarding the securing and training of personnel for the manufacturing and CMC of biopharmaceuticals

  1. Support for Training Immediately Employable Biopharmaceutical Manufacturing Personnel: Continue implementing practical training programs utilizing pharmaceutical companies’ manufacturing facilities and other resources.
  2. Support for the Education of Future Biopharmaceutical Manufacturing Professionals: We will explore and provide opportunities to convey the appeal of biopharmaceutical manufacturing and CMC research and development to current students, as well as educational opportunities.
  3. Human Resource Development for New Modalities: In collaboration with the Biologics Research and Training Center (BCRET), a general incorporated association, we will continue to support human resource development by leveraging the strengths of each company in their respective modalities.

2. Discussions aimed at further promoting the development of biopharmaceutical leads

We will implement follow-up activities for global and regional biotech community initiatives, as well as support for venture and startup creation aimed at bridging the gap between industry, academia, and government (including an entrepreneur support system that utilizes AI to provide chatbot-style consultations addressing various challenges faced by entrepreneurs), and promote concrete measures through co-creation activities with relevant stakeholders.

3. Discussions regarding the utilization of domestic manufacturing infrastructure and domestically produced single-use materials

We will examine challenges and countermeasures for utilizing domestic manufacturing and domestically produced single-use materials from the perspectives of national security and economic security.

4. Investigation and research into the information required in applications for manufacturing and marketing approval of biopharmaceuticals

  1. Review of examples for the Common Technical Document (CTD) and marketing authorization applications for biopharmaceuticals, taking into account Established Conditions (EC) (initial review of EC for manufacturing methods, specifications, and test methods)
  2. Discussions toward the introduction of new change categories
    Continuing discussions within the Japan Agency for Medical Research and Development (AMED) research group, taking into account regulatory changes under the Reiwa 7 amendment to the Pharmaceutical and Medical Devices Act (items to be included in the approval certificate, four types of change categories).
  3. Discussions toward the preparation of the “Draft Guidelines on Quality Assurance for Exosome Preparations”
    Discussions will continue within the AMED research group.

5. Surveys and research on regulations and development related to regenerative medicine, cell therapy, and gene therapy

  1. Improvements to the Cartagena Protocol Implementation

    In collaboration with AMED research groups and the Pharmaceuticals and Medical Devices Agency (PMDA), we will develop materials that contribute to improving the quality of application documents for ministerial approval/confirmation under the Cartagena Act and shortening review periods, and publish these materials on the PMDA website and other platforms.

  2. Study Group on Various Issues Concerning Regenerative Medicine Products

    We will hold monthly discussions at the working-level between the Ministry of Health, Labor and Welfare, PMDA, and industry representatives (the JPMA and the Forum for Innovation in Regenerative Medicine (FIRM)) regarding various issues related to the regulation of regenerative medicine products. We will cooperate in the preparation and issuance of notifications and other documents.

  3. Cooperation with Regulatory Authorities

    We will participate in research on the utilization of Risk Management Plans (RMPs) in post-marketing safety measures for regenerative medicine products, research on Type 1 Use Regulations under the Cartagena Act regarding the initiation of clinical trials using adeno-associated virus (AAV) vectors, and the Project to Promote the Infrastructure for the Practical Application of Gene Therapy, among others, and will work to ensure that the industry’s perspectives are appropriately reflected.

6. Addressing various challenges related to vaccines

1) Strengthening the foundation of vaccine R&D and production/supply systems

  • In preparation for the next infectious disease emergency, we will work to strengthen R&D capabilities for the creation of foundational technologies, while also examining and proposing various measures that contribute to the establishment of a sustainable domestic production and supply system for vaccines—both to ensure stable supply during peacetime and to secure the supply of essential medicines.
  • Based on the Infectious Disease Crisis Management Medicines (MCM) Strategy approved by the Cabinet in February 2026, we will promote initiatives to ensure the effectiveness of long-term, stable vaccine policies.
  • From the perspective of improving predictability, we will clarify the procedures for incorporating high-priority vaccines into routine immunization programs and work to enhance their effectiveness.

2) Reviewing the utilization of vaccines to promote life-course immunization

  • With a view to the digitization of vaccination administration starting in June 2026, we will examine measures for utilizing data that contribute to improving convenience for the public regarding vaccinations and enhancing the efficacy and safety of vaccines.
  • To improve the public’s vaccine literacy, we will promote initiatives related to public awareness and education regarding vaccinations and infectious diseases.

3) Development of regulations and standards for vaccine research and development, manufacturing, and quality control

Through the Vaccine Four-Organization Consultative Body, we will promote ongoing public-private dialogue with the Ministry of Health, Labor and Welfare, the National Institute of Health and Crisis Management (JIHS), and the Pharmaceuticals and Medical Devices Agency (PMDA).

4) Developing human resources to support vaccine research, development, and stable supply

  • We will promote the development of next-generation talent in vaccine research and development by leveraging the Strategic Center for Advanced Research and Development (SCARDA) and industry collaboration networks.
  • We will collaborate with the initiatives for training biomanufacturing professionals promoted by the Biopharmaceutical Committee to foster talent in vaccine manufacturing.

5) Promoting vaccine policies for both peacetime and emergencies in collaboration with the IFPMA Vaccines Committee

We will continue to collect international information related to vaccination and promote measures to combat infectious diseases.

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