Quality-Related Considerations for Human Cell-Derived Extracellular Vesicle (EV) Products at the Time of Initial Clinical Trial Notification — PMDA Early Consideration Summary
Points to Consider for nonclinical safety matters when submitting the initial clinical trial notification — PMDA Early Consideration Summary
Mock-up of Application Form for Confirmation of Change Management Protocol, etc. Related to Change of Strains for Influenza Vaccine or COVID-19 Vaccine — PMDA Early Consideration Summary
Example of Documents on Assessment and Control of DNA Reactive (Mutagenic) Impurities attached to Clinical Trial Notification — PMDA Early Consideration Summary
Considerations for Pre-specifying the Change Categories for Manufacturing Process Parameters Identified as Established Conditions for Drug Products (Chemical Products) — PMDA Early Consideration Summary
Checklist for Quality-Related Documents for Biotechnology Products Derived from Cell Lines of Human or Animal Origin at the Time of Initial Clinical Trial Notification — PMDA Early Consideration Summary
Checklist for Common Inquiry Cases to Be Noted When Submitting Approval Applications for New Active Ingredient Containing Pharmaceuticals (Chemical Products) — PMDA Early Consideration Summary