Good Practice Guide: Non-Investigational Medicinal Products (NIMPs)

Good Practice Guide: Non-Investigational Medicinal Products (NIMPs) cover image

Title:

Good Practice Guide: Non-Investigational Medicinal Products (NIMPs)

Author(s):

Acharya, Ajay; Bergqvist, Anneli; Calnan, Ann; Cruz, Miriam; Degennaro-Culver, Fran; DeVito, Kristen; Falzone, Lisa; Gardner, Beth; Harloff, Christine; Karstadt, Kay-Christian; Kulmburg, Peter; Lundin, Dawn; Main, Karen; Miller, Lee; Muller, Lars; Orosz, Peter; Roy, Sarbari; Sadler-Williams, Esther; von Steiger, Hans; Zobel, Andrea

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Author(s): Acharya, Ajay; Bergqvist, Anneli; Calnan, Ann; Cruz, Miriam; Degennaro-Culver, Fran; DeVito, Kristen; Falzone, Lisa; Gardner, Beth; Harloff, Christine; Karstadt, Kay-Christian; Kulmburg, Peter; Lundin, Dawn; Main, Karen; Miller, Lee; Muller, Lars; Orosz, Peter; Roy, Sarbari; Sadler-Williams, Esther; von Steiger, Hans; Zobel, Andrea

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

Table of Contents

Good Practice Guide: Non-Investigational Medicinal Products (NIMPs)

Pages: 56
Published: January 2013