Thursday, April 9, 2009

Japan good clinical practice rules

Ministry Ordinance 36 issued in 2005
Based on ICH6 and closely aligned with ISO 14155
Parallels the Drug GCP (MHLW Ordinance 28)
6 Chapters, 79 Articles
- Chapter 1. General Provisions
- Chapter 2. Criteria for Preparations for Clinical Trial
- Chapter 3. Criteria for Clinical Trial Management
- Chapter 4. Clinical Trial Criteria
- Chapter 5. Criteria for Reevaluation Documents, Etc.
- Chapter 6. Criteria for Sponsoring Clinical Trial, Etc.
Audit requirement discussed mostly in Articles 21, 31 & 42
JGCP requirements have many similarities to those the US and Europe.
Largely due to MHLW participation in ICH and the ICH Guideline for GCP (E 6)
Closely aligned with ISO 14155 Parts 1 & 2
Basic functions of the Sponsor, Investigators, Informed Consent, Record Retention, and IRB’s are nearly identical to requirements currently in place for the US.

No comments:

Post a Comment