Bioequivalence and Bioavailability Forum

Hi cbertoncini,

❝ Recently ANMAT issued a new document for consultation (ANMAT-MED-BIO-006-00, only in Spanish unfortunately) in which they reset bioequivalence requirements. If the document is approved, bioequivalence will be only required for products registered not longer than 5 years ago and for newly registered products. Older registered products would not require bioequivalence anymore.

I don’t understand the highlighted parts. The ANMAT’s BE-requirements (2006, amended 2007) are pretty detailed. Is it possible that a generic product was registered without demonstrating BE?

❝ Are you guys aware of any agency that has ever issued such a regulation?

In the EU the market authorisation is initially valid for five years and becomes valid for an unlimited period upon renewal acc. to Regulation (EC) No 726/2004, Article 14, 1–3. See the Questions & Answers and linked documents. In the renewal procedure BE studies which lead to the MA generally (!) are not assessed again.