Advanced search
ISPE Good Practice Guide: Harmonizing the Definition and Use of Non-Investigational Medicinal Products cover image

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

Published:January 2013

Pages:56

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

  • 1 Introduction
  • 1.1 Background
  • 1.2 Overview
  • 1.3 Scope
  • 1.4 Purpose
  • 1.5 Benefits
  • 1.6 Key Concepts
  • 2 Regulatory Framework and Considerations
  • 2.1 Summary and Interpretation of Current Regulations Related to NIMPs
  • 2.1.1 EU Guidance and Regulations
  • 2.1.2 US Regulations
  • 2.2 Interpretation of the Regulations
  • 2.2.1 Radiopharmaceuticals
  • 2.3 Is the Medicinal Product an IMP or a NIMP?
  • 2.3.1 Examples Using the Flow Chart in Figure 2.2
  • 2.4 NIMPs without Market Authorizations and Off-label Use
  • 2.4.1 Off-label Use of Background Medication as NIMPs
  • 3 Technical Aspects of NIMPs in Clinical Trials
  • 3.1 Sourcing Strategy
  • 3.1.1 Central Sourcing
  • 3.1.2 Local Sourcing
  • 3.1.3 Blended Sourcing
  • 3.2 Considerations When Compiling a Sourcing Strategy
  • 3.2.1 Options for Local Sourcing
  • 3.2.2 Counterfeiting
  • 3.2.3 Duties and Taxes
  • 3.3 Packaging and Labeling
  • 3.3.1 Packaging and Labeling for Centrally Sourced NIMPs
  • 3.3.2 Packaging and Labeling for Locally Sourced NIMPs
  • 3.3.3 Release
  • 3.4 Storage and Distribution
  • 3.5 Management of Drug Traceability, Accountability, Returns, and Destruction
  • 3.5.1 Drug Traceability
  • 3.5.2 Drug Accountability/Reconciliation
  • 3.5.3 Returns and Destruction
  • 3.6 Management of Complaints and Recalls Associated with NIMPs
  • 3.7 Management of Adverse Events Associated with NIMPs
  • 3.8 Comparison of the Impact Sourcing Strategy on NIMP Management
  • 4 Commercial Aspects for Consideration
  • 4.1 Reimbursement
  • 4.1.1 Reimbursement to Investigators
  • 4.1.2 Requirement for Subjects
  • 4.1.3 NIMPs as Standard of Care for Subjects
  • 4.1.4 Other Classifications of NIMPs for Subjects
  • 5 Appendix 1 - Knowledge Sharing Table
  • 6 Appendix 2 - References
  • 7 Appendix 3 - Glossary
  • 7.1 Acronyms and Abbreviations
  • 7.2 Definitions
  • Ajay Acharya, Merck & Co., Inc., USA
  • Anneli Bergqvist, AstraZeneca, Sweden
  • Ann Calnan, GlaxoSmithKline (GSK), United Kingdom
  • Miriam Cruz, Eisai, USA
  • Fran Degennaro-Culver, Merck & Co., Inc., USA
  • Kristen DeVito, Catalent Pharma Solutions, USA
  • Lisa Falzone, Bayer Healthcare Pharmaceuticals, USA
  • Beth Gardner, Takeda, USA
  • Christine Harloff, Bayer Pharma AG, Germany
  • Kay-Christian Karstadt, Multipharma GmbH, Germany
  • Peter Kulmburg, Roche, Switzerland
  • Dawn Lundin, Merck & Co., Inc., USA
  • Karen Main, Astra Zeneca, USA
  • Lee Miller (Co-Lead), Merck & Co., Inc., USA
  • Lars Muller, Novo Nordisk A/S, Denmark
  • Peter Orosz, Boehringer Ingelheim, Germany
  • Sarbari Roy, AstraZeneca, Sweden
  • Esther Sadler-Williams (Co-Lead), Catalent Pharma Solutions, United Kingdom
  • Hans von Steiger, Pfizer Inc., USA
  • Andrea Zobel, Marken Ltd., Germany

A Non-Investigational Medicinal Product (NIMP) is a medicinal product not defined within the description of an IMP and may be considered a background, challenge, concomitant, endpoint, escape, or rescue medication dosed for preventive, diagnosis, or therapeutic reasons. NIMP is EU terminology, but has been accepted globally within the pharmaceutical industry. Currently there are no complete regulations or practical guidelines for NIMPs and pharmaceutical organizations may overcomplicate their clinical trials by submitting products as IMPs when they could have been managed as NIMPs.

The ISPE Good Practice Guide: Harmonizing the Definition and Use of Non-Investigational Medicinal Product (NIMPs) is intended to provide an overview of regulatory requirements and to help to alleviate regulatory and operational ambiguity surrounding NIMPs.

Definitions of key terms are provided and the Guide summarizes current consensus on what the pharmaceutical industry and regulations/guidelines define as NIMPs. In addition, an appendix is provided that categorizes regions or countries according to regulations and practices related to NIMPs. Current approaches to supply chain management of NIMPs are also considered.