Links to major regulatory information of Vaccines and Blood Products.
Regulations and Notifications
Vaccines for Infectious Disease
Non-Clinical Studies
March 27, 2024 PSB/PED Notification No. 0327-1
March 27, 2024 Administrative Notice
- Considerations on Utilization of the Platform-based Approach in Non-Clinical Safety Evaluation of mRNA-LNP Vaccines for Prevention of Infections (Early Consideration)[170KB]
February 6, 2026 Office of Vaccines and Blood products, Pharmaceuticals and Medical Devices Agency
Clinical Studies
March 27, 2024 PSB/PED Notification No. 0327-4
- (Attachment) Questions and Answers (Q & A) on Guidelines for Clinical Studies of Vaccines for Infectiousa Disease Prevention [120.91KB]
March 27, 2024 Administrative Notice
April 7, 2016 PSEHB/ELD Notification No. 0407-1
Prototype Vaccines
October 31, 2011 PFSB/ELD Notification No. 1031-1
Vaccines Against the Novel Coronavirus SARS-CoV-2
May 29, 2024 Office of Vaccines and Blood products, Pharmaceuticals and Medical Devices Agency
July 15, 2022 Office of Vaccines and Blood Products Pharmaceuticals and Medical Devices Agency
October 22, 2021 Office of Vaccines and Blood Products Pharmaceuticals and Medical Devices Agency
June 11, 2021 Office of Vaccines and Blood Products, Pharmaceuticals and Medical Devices Agency
April 5, 2021 Office of Vaccines and Blood Products, Pharmaceuticals and Medical Devices Agency
September 2, 2020 Office of Vaccines and Blood Products, Pharmaceuticals and Medical Devices Agency
Collaboration with Foreign Regulatory Authorities
The market authorization application for “Kostaive” was reviewed collaborating and sharing information with EMA under the framework called “OPEN initiative”.
- Report on the Deliberation Results [1.33MB]
November 28, 2023 Pharmaceutical Evaluation Division, Pharmaceutical Safety Bureau Ministry of Health, Labour and Welfare
Change of Strains for Influenza Vaccine or COVID-19 Vaccine
Partial Change Application
- Principles for the Evaluation of Vaccines Against the Novel Coronavirus SARS-CoV-2 (Appendix 5) Quality data required for the approval review of changing a strain in the vaccine for which the manufacturing process is well established (Early consideration) [108KB]
May 29, 2024 Office of Vaccines and Blood products, Pharmaceuticals and Medical Devices Agency - Handling of Changes to COVID-19 Vaccine Strains (Notification)[30.4KB]
May 23, 2024 PSB/PED Notification No. 0523-1, PSB/CND Notification No. 0523-3 - Handling of Influenza Vaccines Manufactured Using Strains Other than Those Dispensed by the National Institute of Infectious Diseases (Notification)[30.6KB]
January 31, 2024 PSB/PED Notification No. 0131-1, PSB/CND Notification No. 0131-1
Applications for Confirmation of Change Protocols
- Handling of Application for Confirmation of Change Protocol Related to Change of Strains for Influenza Vaccine or COVID-19 Vaccine[34.1KB]
October 3, 2025 PSB/PED Notification No. 1003-1 - Questions and Answers (Q&A) about Handling of Application for Confirmation of Change Protocol Related to Change of Strains for Influenza Vaccine or COVID-19 Vaccine[39.7KB]
October 3, 2025 Administrative Notice - Mock-up of Application Form for Confirmation of Change Management Protocol, etc. Related to Change of Strains for Influenza Vaccine or COVID-19 Vaccine (Early Consideration)[331KB]
October 3, 2025 Office of Vaccines and Blood products, Pharmaceuticals and Medical Devices Agency
Recombinant Virus Vaccines
March 27, 2024 PSB/PED Notification No. 0327-7
- (Attachment) Questions and Answers (Q & A) on Guidelines for the Development of Recombinant Virus Vaccines for Infectious Disease Prevention[136KB]
March 27, 2024 Administrative Notice - Considerations on Development of Recombinant Virus Vaccines for Prevention of Infections[90.6KB]
Project for Promotion of Health, Labour and Welfare Administration FY2017 (Project for Regulatory Science Policy Research for Products Including Pharmaceuticals and Medical Devices)
Blood Products
Human Immunoglobulin Products
- Principles for Obtaining Indications based on Comparative Evaluation, etc. of the Quality Attributes of Intravenous Human Immunoglobulin Products [175.46KB]
June 30, 2023 PSEHB/PED Notification No. 0630-5
Related Guidelines and Standards
Standards for biological raw materials
MHLW Notification No.210.2003
- Standards for Biological Raw Materials, Operational Guideline[183.51KB]
October 2, 2014 PFSB/ELD Notification No. 1002-1, PFSB/MDRMPE Notification No. 1002-5 - Questions and Answers (Q&A) on the Operation of the Standards for Biological Raw Materials[141KB]
June 30, 2015 Administrative Notice