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RegisterTimeline for protocol approval by DCGI [Regulatives / Guidelines]
hi,
The study protocol meant for BE NOC for export purpose takes 28 days time for approval by DCGI if all required documents in a defined format have been submitted to them. The post approval changes can be notified to DCGI prior to initiate the study, if changes do not include change in formulation itself or major changes in study design, or any other change which needs to be evaluated on case to case basis.
Regards,
kapil.
Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
The study protocol meant for BE NOC for export purpose takes 28 days time for approval by DCGI if all required documents in a defined format have been submitted to them. The post approval changes can be notified to DCGI prior to initiate the study, if changes do not include change in formulation itself or major changes in study design, or any other change which needs to be evaluated on case to case basis.
Regards,
kapil.
Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
Complete thread:
- Timeline for protocol approval by DCGI auditor 2010-10-11 12:23
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Timeline for protocol approval by DCGI raghu 2010-10-13 07:30
- Timeline for protocol approval by DCGIkapil pandya 2010-11-18 07:17
Ing. Helmut Schütz