オンライン教材

PMDA-ATC E-ラーニング コンテンツ

リンクをクリックすると、YouTube上で動画を再生できます。
コンテンツは随時追加・更新を行っていく予定です。
※一部のコンテンツには最新の情報が反映されていない可能性があります。

Review

1. Review Teams
2. Application Dossier
3. Review Process
4. Japanese Pharmacopoeia (JP)
5. Review of Generic Drugs
6. Review of Biosimilars
7. First-in-Human Studies
8. Review of Regenerative Medicinal Product
9. Expedited Regulatory Pathways in Japan
10. Consultation Service
11. Good Registration Management (GRM)
12. Drug Master File System in Japan
13. Approval Review Quoting Drug Master File
14. Review of Chemistry, Manufacturing and Control (CMC)
15. Review of Over The Counter (OTC) Drugs
16. History of Drug Evaluation using Foreign Clinical Data in Japan 
17. Why MRCT? 

Safety

［新規］リスク最小化活動に関するコンテンツを公開しました。

1. Safety Measures
2. E-labeling System in Japan
3. Pharmacovigilance activity utilizing Real World Data in PMDA
4. Risk Management Plan(RMP)
5. Risk Minimization Activity　New!

Relief

1. The Relief System
2. The Relief System for ADR
3. Judgement on the Relief System

Medical Device

1. Medical Device and In Vitro Diagnostic (IVD) Regulations
2. Review of Medical Devices
3. Review of In Vitro Diagnostics (IVDs)
4. QMS and Safety Measures
5. Medical Device Unit
6. Review of IVD for COVID-19

GxP

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

PMDA Efforts

1. Philosophy
2. Organization
3. Achievements
4. The PMDA International Strategic Plan
5. International Activities
6. The PMDA-ATC Seminar
7. Measures against COVID-19 (as of Apr.1, 2021)
8. Message from the Chief Executive of PMDA
9. Center for Regulatory Science