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RegisterANMAT – Bioquivalence requirements under consultation [BE/BA News]
Dear all,
I’m writing from Argentina. Bioequivalence has been historically under debate and tough scrutiny in this country. Despite several regulations issued by the local health authority (ANMAT) there are just a few bioequivalent products available in the local market.
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. Are you guys aware of any agency that has ever issued such a regulation?
Thanks a lot for your comments.
Edit: Category changed and document linked. [Helmut]
I’m writing from Argentina. Bioequivalence has been historically under debate and tough scrutiny in this country. Despite several regulations issued by the local health authority (ANMAT) there are just a few bioequivalent products available in the local market.
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. Are you guys aware of any agency that has ever issued such a regulation?
Thanks a lot for your comments.
Edit: Category changed and document linked. [Helmut]
Complete thread:
- ANMAT – Bioquivalence requirements under consultationcbertoncini 2016-04-12 14:17 [BE/BA News]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- ANMAT – Bioquivalence requirements under consultation Helmut 2016-04-13 13:12
- ANMAT – Bioquivalence requirements under consultation cbertoncini 2016-04-13 20:18
- History Helmut 2016-04-14 14:41
- ANMAT – Bioquivalence requirements under consultation cbertoncini 2016-04-13 20:18
- ANMAT – Bioquivalence requirements under consultation Helmut 2016-04-13 13:12
Ing. Helmut Schütz