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NOTICE: We are performing maintenance on the ISPE Guidance Documents Portal on Tuesday 14 May. Current users can access their existing content, however, new purchases cannot be made. We apologize for any inconvenience this may cause.
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:
ISPE members located in nations with emerging economies* are eligible for a 50% discount on publications from the regular member price. To receive the discount, members must be logged in with their ISPE member account. Contact Member Services at ask@ispe.org for more information or if you have questions about your membership status or this discount program. Discounts do not apply to Techstreet document downloads.
*Based on the World Bank's system for classifying national economies by GNI per capita. Includes low-income, lower middle-income, and upper middle-income economies. To learn more about the World Bank classification system, please click here. Currently includes the following nations, except where international sanctions apply: