shiv
●    

2006-01-25 06:39

Posting: # 60
Views: 12,757
 

 ANVISA Approval [Regulatives / Guidelines]

BE studies for Brazil is after ANVISA approval
H_Rotter
★    

Germany,
2006-01-25 12:31

@ shiv
Posting: # 62
Views: 9,845
 

 ANVISA Approval

Dear shiv,

...and what is your question? :confused:
shiv
●    

2006-01-27 08:14

@ H_Rotter
Posting: # 66
Views: 9,926
 

 ANVISA Approval

Dear Rotter,

Conducting BE studies for brazil market is only after anvisa inspection and approval or after the study, submission of documents and inspection process (Like FDA)?
H_Rotter
★    

Germany,
2006-01-27 14:00

@ shiv
Posting: # 68
Views: 9,766
 

 ANVISA Approval

Dear shiv,

it's different from the FDA.
The center(s) performing the study must follow ANVISA's rules (http://www.anvisa.gov.br/eng/legis/resol/103_03rdc_e.htm), must be inspected (http://www.anvisa.gov.br/eng/bio/form_bio.doc), and renew their status anually (http://www.anvisa.gov.br/eng/bio/form_renewal.rtf). After approval of the protocol by the local IEC, the study may be performed.

Only if your protocol deviates from ANVISA's standards (e.g. if you want to perform at multiple dose study in order to reduce variability for HVDs), I would strongly recommend contacting them before.

good luck!
Hermann Rotter
Activity
 Thread view
Bioequivalence and Bioavailability Forum |  Admin contact
19,567 posts in 4,150 threads, 1,340 registered users;
online 5 (0 registered, 5 guests [including 4 identified bots]).
Forum time (Europe/Vienna): 22:31 CEST

Mediocrity knows nothing higher than itself,
but talent instantly recognizes genius.    Arthur Conan Doyle

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5