(Note)
You will be transferred to an external website (YouTube : Pmda Channel) by clicking the title below.
There is also PLAYLIST that sequentially plays all the movies in this category.
- Review Teams
- Application Dossier
- Review Process
- Japanese Pharmacopoeia (JP)
- Review of Generic Drugs
- Review of Biosimilars
- First-in-Human Studies
- Review of Regenerative Medicinal Product
- Expedited Regulatory Pathways in Japan
- Consultation Service
- Good Registration Management (GRM)
- Drug Master File System in Japan
- Approval review referring Drug Master File
- Review of Chemistry, Manufacturing and Control (CMC)
- Review of Over The Counter (OTC) Drugs
- History of Drug Evaluation using Foreign Clinical Data in Japan
- Why MRCT?
- Orphan Drug Designation System in Japan
- Non-clinical Safety Evaluation for Cellular and Tissue-based Products
- Non-clinical Safety Evaluation for in vivo Gene Therapy Products
- Bioequivalence Studies
- Quality Control for Cell and Gene Therapy Products