Learning Videos : Pharmaceuticals

(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 [PLAYLIST]

1. Review Teams
2. Application Dossier
3. Review Process
4. Japanese Pharmacopoeia (JP)
5. Review of Generic Drugs
6. Bioequivalence Studies
7. Review of Biosimilars
8. First-in-Human Studies
9. Expedited Regulatory Pathways in Japan
10. Good Registration Management (GRM)
11. Overview of Drug Master File System in Japan July 1, 2025 updated
12. Approval review referring Drug Master File
13. Review of Chemistry, Manufacturing and Control (CMC)
14. Review of CMC for Biotechnology-Derived Products July 1, 2025 newly posted
15. Review of Over The Counter (OTC) Drugs
16. Why MRCT?
17. Orphan Drug Designation System in Japan

Safety [PLAYLIST]

1. Risk Management Plan(RMP)
2. Pharmacovigilance Activities
3. Risk Minimization Activity
4. E-Labeling System in Japan
5. Risk Communication
6. Pharmacovigilance activity utilizing Real World Data in PMDA

GxP [PLAYLIST]

1. GMP/GCTP Inspection
2. Good Laboratory Practice
3. Toxicology Studies
4. Good Clinical Practice
5. GCP Inspections Procedure in Japan
6. Remote GMP Inspection
7. New Approach for GMP/GCTP Compliance Inspection System