ISPE GPG: Harmonizing the Definition and Use of NIMPs

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Published: January 2013
Pages: 56

Table of Contents

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Recent survey results show that the pharmaceutical companies often take an overly conservative approach to NIMPs (or Non-IMPs) due to regulatory and operational ambiguity. This can lead to unnecessary expenses and process steps, which can needlessly complicate clinical trials.

The ISPE Good Practice Guide: Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs) aims to provide practical operational guidance and drive a consistent industry approach to the use of NIMPs. The Guide contains criteria for classifying NIMPs and an overview of current NIMP regulatory requirements.

This in-depth Guide will help you properly manage NIMPs by providing guidance on: