Printable Handouts

PDF

Navigable Slide Index

1. Introduction
2. Outlines
3. OECD guidance
4. Number of GLP monitoring programs
5. GLP monitoring programs in Japan
6. Relationship (1)
7. Relationship (2)
8. Relationship (3)
9. Relationship (4)
10. Overview of each program
11. Medical products program
12. Workplace chemicals program
13. Pesticides program
14. Industrial chemicals program
15. Compliance monitoring authority
16. Monitoring authority for medical products
17. Marketing approval process
18. MHLW vs. PMDA
19. Legal basis and regulatory requirements
20. GLP standards for medical products
21. Contents of GLP standards (1)
22. Contents of GLP standards (2)
23. Contents of GLP standards (3)
24. Enforcement notices of GLP standards
25. Other act, regulation, and notice concerned
26. Pharmaceutical affairs act
27. Enforcement regulation of pharmaceutical affairs
28. Law on incorporated administrative agency
29. On-site GLP inspections for drugs/devices
30. Preparation of document for GLP inspections
31. Unofficial publications concerned with GLP
32. Normal practices of inspections
33. Types of GLP inspections
34. Timelines for GLP inspection
35. Pre inspection (step 1)
36. Pre inspection (step 2)
37. Pre inspection (step 3)
38. Usual inspection schedule
39. Usual practice of inspection
40. Pharmaceuticals
41. Medical devices
42. Follow-up to inspection
43. Reporting to the GLP evaluation committee
44. Final result of GLP inspection
45. Corrective Action
46. Grade B
47. Grade C
48. Summary

Topics Covered

• Complexity of Japanese GLP monitoring programmes
• Review and comparison of all four GLP programmes
• Detailed explanation of medical products programme
• Compliance Monitoring Authority, legal bases, and regulatory requirements of medical products programme
• Normal practices and follow-ups of GLP inspection in medical products programme

Links

Series:

• Good Laboratory Practice

Categories:

• Methods
• Pharmaceutical Sciences

Talk Citation

Someya, H. (2012, March 1). Regulatory requirements in Japan and its compliance monitoring programmes [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved April 20, 2024, from https://hstalks.com/bs/2254/.
Export Citation (RIS)

Publication History

• Published on March 1, 2012

Financial Disclosures

• Dr. Hitoshi Someya has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.