My contact who is very farmiliar with the MCAZ regulations says that according to the guidelines MCAZ require 12 months long term stability data at the time of submission. In principle, the decision to accept or reject an application at screening stage depends on the TYPE of deficiency and the NUMBER of the critical deficiencies. So if there is only 6 months real time, this will be noted as a critical deficiency at screening stage. If this is the only critical deficiency, the application will proceed to the evaluation stage but at least 12 months long term data should be available before approval. However, if this deficiency plus any other two or more critical deficiencies in the submission, the application will not proceed to the evaluation stage i.e. not accepted until the deficiencies have been addressed.
I hope this helps.
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Jude Nwokike RAC
Principal Technical Advisor/Global lead Regulatory Affairs & Pharmacovigilance
Management Sciences For Health, MSH
Arlington VA
United States
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Original Message:
Sent: 07-26-2013 01:28
From: Anil Chillarge
Subject: Zimbabwe stability data during dossier submission
As per guidance Zimbabwe require 12 month zone IV stability data at the time of submitting the dossier. Can MCAZ accepts 6M zone IV stability data during submission. Do anyone has practical experience with this situation?
Anil Chillarge
Senior Manager
Glenmark Pharmaceuticals Ltd
Mumbai
India
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