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RegisterANVISA and Malaysian authorities invitation to audit CRO [Regulatives / Guidelines]
Dear Rasha_J
Bioequivalence studies which should support submissions for generic drugs in Brazil are only accepted by ANVISA if the CRO (clinics and bioanalytical lab) is authorized, i.e. you need to invite ANVISA first before initiating a study for the Brazilian market.
Unfortunately I have no experience with Malaysian authorities. I only know that studies with the European RLD needed to be repeated and the Malaysian authorities can be quite complicated...
Bioequivalence studies which should support submissions for generic drugs in Brazil are only accepted by ANVISA if the CRO (clinics and bioanalytical lab) is authorized, i.e. you need to invite ANVISA first before initiating a study for the Brazilian market.
Unfortunately I have no experience with Malaysian authorities. I only know that studies with the European RLD needed to be repeated and the Malaysian authorities can be quite complicated...
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- ANVISA and Malaysian authorities invitation to audit CRO Rasha_J 2016-11-01 09:07 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- ANVISA and Malaysian authorities invitation to audit CRODr_Dan 2016-11-02 15:13
- ANVISA and Malaysian authorities invitation to audit CRO Rasha_J 2017-05-11 06:58
- ANVISA and Malaysian authorities invitation to audit CRODr_Dan 2016-11-02 15:13
Ing. Helmut Schütz