Vaccines and Blood Products

Links to major regulatory information of Vaccines and Blood Products.

Regulations and Notifications

Clinical Trials

• Guidance on Clinical Evaluation of Travelers’ Vaccines, etc. [228.13KB]

April 7, 2016 PSEHB/ELD Notification No. 0407-1

Vaccines Against the Novel Coronavirus SARS-CoV-2

• 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)[108.29KB]

May 29, 2024 Office of Vaccines and Blood products, Pharmaceuticals and Medical Devices Agency

• Principles for the Evaluation of Vaccines Against the Novel Coronavirus SARS-CoV-2(Appendix 4) Immunogenicity-based evaluation of variant vaccines modified from parent vaccines and booster vaccines with new active ingredients [172.94KB]

July 15, 2022 Office of Vaccines and Blood Products Pharmaceuticals and Medical Devices Agency

• Principles for the Evaluation of Vaccines Against the Novel Coronavirus SARS-CoV-2(Appendix 3) Evaluation of the vaccines based on Immunogenicity [158.84KB]

October 22, 2021 Office of Vaccines and Blood Products Pharmaceuticals and Medical Devices Agency

• Principles for the Evaluation of Vaccines Against the Novel Coronavirus SARS-CoV-2(Appendix 2) Ethical Considerations for Subjects in Placebo-Controlled Studies [142.88KB]

June 11, 2021 Office of Vaccines and Blood Products, Pharmaceuticals and Medical Devices Agency

• Principles for the Evaluation of Vaccines Against the Novel Coronavirus SARS-CoV-2(Appendix 1) Evaluation of vaccines against variants [156.00KB]

April 5, 2021 Office of Vaccines and Blood Products, Pharmaceuticals and Medical Devices Agency

• Principles for the Evaluation of Vaccines Against the Novel Coronavirus SARS-CoV-2 [387.83KB]

September 2, 2020 Office of Vaccines and Blood Products, Pharmaceuticals and Medical Devices Agency

Standards for biological raw materials

• Standards for biological raw materials[73.55KB]

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