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This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines. It represents the Medicines Control Council’s current thinking on the safety, quality and efficacy of medicines.
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This Indicator-Based Pharmacovigilance Assessment Tool (IPAT) was developed as a comprehensive performance metric for pharmacovigilance and medicine safety systems.
Cochrane Database Syst Rev. 2016 Jul 1; (6): 1–61 -Published online 2016 July 1
