ISPE Good Practice Guide: Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs)

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Published: January 2013
Pages: 56
Table of Contents ( 215 KB)

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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:

  • Sourcing strategies
  • Packaging and labeling approaches
  • Storage and distribution recommendations
  • Regulations categorized by region/country
  • Approaches to management of drug accountability, traceability, complaints and recalls with reference to the original sourcing strategy
  • Regulatory differences between NIMPs and comparators
Last Update: 14 June 2013

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