Overseas GCP inspections by the Japanese Regulatory Agency: a systematic review of 13 cases (1998–2003)

Since ICH E5 was implemented in 1998, Pharmaceutical and Medical Devices Evaluation Center (PMDEC), National Institute of Health Science, Ministry of Health and Welfare (MHLW) has conducted Good Clinical Practice (GCP) inspections targeting overseas clinical facilities, sponsors, Contract Research Organizations (CROs) and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs). The Japan Society of Quality Assurance (JSQA) reviewed such overseas GCP inspections to study how inspections were initiated, prepared and executed by collecting detailed data from JSQA member companies. GCP inspections were conducted outside Japan (i.e. overseas) when data generated from overseas clinical studies were critical to supporting the efficacy and/or safety claims of a pharmaceutical product for approval in the Japanese market. JSQA identified a total of 13 overseas GCP inspections in 23 cases conducted by the Japanese regulators between 1998 and 2003. Our survey showed the following: 1. Inspections were usually over the course of a single day per facility, and conducted on a ‘question-and-answer’ basis in Japanese via independent interpreter(s). 2. Compliance with Japanese-GCP (not ICH GCP) was primarily taken into account when regulators evaluated whether overseas clinical data were acceptable for the NDA review in Japan. 3. Inspection reports were disclosed only to Japanese applicants. Upon receipt of the inspection pre-notice, Japanese applicants were encouraged to promptly respond to the agency, and simultaneously prepare for the inspection by cooperating with in-house collaborators located both overseas and in Japan. Copyright © 2005 John Wiley & Sons, Ltd.