Bioequivalence and Bioavailability Forum

Dear akinapally!

❝ Which regulatory agencies provide facility approvals for conducting/submitting BA/BE studies.

❝ E.g. If CRO not having facility approval like (WHO, MOH Turkey or ANVISA)

Add Jordan Food and Drug Administration. Note that no facility approval process exists in the European Union and associated members states (Norway, Iceland, Liechtenstein). The same holds for Switzerland. You have to adher to the rules of GCP implemented in national drug laws.

❝ can we do study and can able to file for approval?

Yes. Some European countries have a 100% inspection policy if a study is submitted to them as the reference member state in a MRP. So expect to see one of these guys sooner or later.