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The following message was posted to: PharmPK
Dear group,
Does anybody know what are the current procedures in Argentina (or
the procedures likely to be in force by the end of this year) to
apply for a clinical trial authorization? I had a look at the
Argentinian agency website, the ANMAT, and I am getting somewhat
confused.
I would value your feedback on this.
Best regards,
Henri MERDJAN
Head of Drug Metabolism and Pharmacokinetics
NOVEXEL S.A., Parc Biocitech, 102 Route de Noisy
F-93230 Romainville, France
Tel +33 (0)1 57 14 07 45
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The following message was posted to: PharmPK
Dear Henri,
The regulation for clinical trials in Argentina is
number 5330/1997. It is written in spanish and I do
not know if there is any translation. The link is:
http://www.anmat.gov.ar/Normativa/Normativa/Medicamentos/
Disposicion_ANMAT_5330-1997.pdf
There are some other regulations (for the inspection
of clinical investigators, adverse events, etc) that
you can find from
http://www.anmat.gov.ar/principal.htm, and then, click
in medicamentos, legislacion, normativas.
Best regards,
Paula
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In the following site:
http://www.anmat.gov.ar/principal.htm
the ANMAT Dispositions related to Buenas Practicas de Investigacion en
Farmacologia Clinica could be found:
Ano Tipo de Norma Descripcion
2005 Disposicion No 2124/05 Efectos Adversos en Ensayos
Clinicos.- BO
22/04/05
2005 Disposicion No 690/05 Investigadores clinicos. Aprueba la
guia de
inspeccion a investigadores clinicos.- BO 09/02/05
1999 Disposicion N* 853/99 Cumplimiento de BPFyC, OMS 1992.- BO
03/03/99
1998 Disposicion No 3436/98 Conformacion que efectuara la
Comision
Evaluadora y Asesora de Ensayos Clinicos de la Coordinacion de
Evaluacion de
Medicamentos y Afines, en relacion a modificaciones a los estudios
clinicos
ya autorizados.BO 24/07/98
1997 Disposicion N* 5330/97 Ampliacion de Buenas Practicas de
Investigacion en Farmacologia Clinica.- BO 21/10/97
1996 Disposicion N* 4854/96 Buenas Practicas de Investigacion en
Farmacologia Clinica.- BO 13/11/96
Particularly Disp. 5330/97 is the main one in order to apply.
I hope this helps.
Regards, silvia
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