Starting on January 31, the PMDA will adopt its on-site GCP inspections according to the past performance of facilities that do drug and regenerative medicine clinical trials. At clinical trial facilities where inspections have been carried out very often, certain documentation will no longer be required to be submitted, including things like – IRB operational procedures, summaries of qualifications of the facilities doing the clinical trials, clinical trial operations procedures, etc. For these facilities, a streamlined onsite inspection will include – 1. Proof of how investigational drugs are dealt with, 2. Brief interviews with clinical trial staff, 3. Verification on how clinical trial documents are kept, 4. which specific documents will need to be shared during the inspection, etc. Clinical trial facilities will be advised in advance of whether they qualify for a streamlined on-site inspection.
On the other hand, clinical trial facilities that have had previous GCP problems will have a more in-depth onsite audit. In addition to the standard GCP requirements, these facilities will need to have extensive detailed on-site discussions with the PMDA auditors and lead investigators, clinical staff, clinical administrative people, etc. They will need to provide more clinical trial documentation as well. For these more in-depth on-site inspections, the PMDA will also let the facility or facilities know what other additional documentation will need to be provided in advance.
The past quality of the clinical trial facilities will also determine the level of scrutiny for Good Post Marketing Clinical Study Practice. Facilities with previous poor track records are getting more attention.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.