Biopharmaceutical Committee Regenerative Medicine Product: Analysis of Application Documents for Approval (Life Cycle Management Information)
The Biopharmaceutical Committee's Technical Working Group 3 Study Group has compiled in Excel a comprehensive analysis of product information and studies used in the review of approved regenerative medicine products with reference to review reports and published documents.
We hope that this will be of some help to those working on the development of regenerative medical products to deepen their understanding and reduce their workload.
Please note that the information is based on the confirmed documents, but if you wish to confirm the details of individual items, please contact the Pharmaceuticals and Medical Devices Agency (PMDA) directly or access the website of the relevant company to confirm the details.
- *Please note that some of the hyperlinks in the Excel may not be displayed.
March 2021 Deliverable
- 01_Basic Information
- 02_CMC Items (List and Appendix)
- 03-00_Non-clinical/Clinical
- 03-01_Non-clinical/Clinical Jack
- 03-02_Non-Clinical/Clinical Jace 2-1
- 03-03_Non-Clinical/Clinical Jace2-2
- 03-04_Non-Clinical/Clinical Jace2-3
- 03-05_Non-clinical/Clinical Temsel
- 03-06_Non-Clinical/Clinical Heart Sheet
- 03-07_Non-clinical/Clinical Stemilac
- 03-08_Non-clinical/Clinical Kymriah Intravenous Infusion
- 03-09_Non-clinical/Clinical Collategene
- 03-10_Non-clinical/Clinical Collategene
- 03-11_Non-clinical/Clinical Nepic
- 04_List of PMS
- 05_Conditions for Approval
Issued March 2021
Prepared by Technical Working Group 3, Technical Working Group 3, Biopharmaceutical Committee
March 2022 Deliverable
- 01_Basic Information
- 02_CMC Items (List and Appendix)
- 03-00_Non-clinical/Clinical
- 03-01_Non-clinical/clinical YESCALTA Intravenous Infusion
- 03-02_Non-clinical/Clinical Breyanzi Injection
- 03-03_Non-clinical/clinical Ocular
- 03-04_Non-clinical/clinical Delictact Injection
- 04_List of PMS
- 05_Conditions for Approval
March 2022 Issued by
Prepared by Technical Working Group 3, Technical Working Group 3, Biopharmaceutical Committee
March 2023 Deliverables
Issued March 2023
Prepared by Technical Working Group 3, Technical Working Group 3, Biopharmaceutical Committee
March 2024 deliverables
Items Created
Additional indications: Kymriah for intravenous infusion, Breyandji for intravenous infusion, Yescarta for intravenous infusion
New applications: Carbiquity for intravenous infusion, Jasmin, Biznova
Issued March 2024
Prepared by Technical Working Group 3, Biopharmaceutical Committee
Deliverables for March 2025
Items Created
Additional Indication: Avecma Intravenous Injection
New Application: Luxterna Injection
April 2025 Issued by
Prepared by Technical Working Group 3, Technical Working Group 3, Biopharmaceutical Committee