Japan Issues Guidance on Medical Device GCP Compliance Reviews

The Japanese Ministry of Health, Labor, and Welfare (MHLW) has issued guidance (Notification 0715006, July 2005) on GCP compliance reviews of clinical trial documentation for medical device shonin applications. Both the MHLW and the Pharmaceuticals and Medical Devices Agency (PMDA), the consultative arm of the MHLW, will conduct compliance reviews.

The GCP compliance reviews will include examinations of both the reference documents as well as the medical device clinical trial sites to ensure that all clinical trials have been conducted in accordance with Japanese GCP. The document review will encompass all reference documents generated in the clinical trial, including the protocol, reports on monitoring, adverse events, data collection and analysis, and clinical results, as well as the clinical trial summary report. The PMDA will review these documents when the shonin application is submitted to the PMDA. The MHLW may review these documents in special circumstances where the MHLW questions the credibility of the documentation.

Representatives from the PMDA will travel to the clinical site to conduct a site audit. The government representative will then generate a summary report of the audit. The shonin applicant will then receive a designation of GCP compliance or non-compliance. After receiving a negative ruling of non-compliance with GCP, the applicant may undergo a re-evaluation by submitting additional information to the PMDA in support of the shonin application.

Any applicant that refuses an audit or presents false information will automatically be given a non-compliance judgment. Clinical trial documents that have already been submitted in a previous shonin application dossier, or documents that are part of a dossier that has already obtained shonin approval, are exempt from the review.