Bioequivalence and Bioavailability Forum

Dear Dan!

I agree 100%. Jordan’s FDA is particular since last year they refused to assess an application before they get the “GCP approval” of the CROs. One of the studies in the package was inspected by the Austrian authority and the lab was GLP-certified. Such a requirement is not stated in their own “Law of clinical studies”…
One veiled lady of the JFDA asked about such a certificate at two conferences I was attending. Members of EMA’s PK Working Party told her that such a procedure does not (did not / will not) exist. Shaking her head in disbelief she was obviously not happy with the answer. I was the chairman that day and gave this example: Murder is against law but would you go to the ministry of justice and expect to obtain a certificate stating “Mr X is not a murderer”? Didn’t seem funny to her.