ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Investigational Medicinal Product (IMP)

The definition of an Investigational Medicinal product (IMP) is provided in Directive 2001/20/EC, Article 2 (d) (2), as “a pharmaceutical form of an active substance or placebo being tested or used as areference in a clinical trial, including products already with a marketing authorization but odofied (change to dosage form, or its primary or secondary packaging) in a way different from the authorized form, or when used for an unauthorized indication, or when used to gainfurther information about the authorized form”.



Medicinal products with a marketing authorization (MA) are classified as IMPs when they are to be used as the test drug or reference drug in a clinical trial, provided they are used or assembled (formulated or packaged) in a way different from the authorized form, or used for an unauthorized indication, or used to gain further information about the authorized form. On this basis, provided that the requirement(s) are met, reference products used as comparators should be considered as IMPs.

Publication Source: ISPE Good Practice Guide: Comparator Management

Publication Date: 2012

Investigational Medicinal Product (IMP)

Packaged and labeled drug product including placebos and comparators intended for use in a clinical trial.

Publication Source: ISPE Good Practice Guide: Interactive Response Technology

Publication Date: 2011

See also:

Investigational Medicinal Product (IMP)

A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorization, but used or assembled (formulated or packaged) in a way different from the authorized form, or when used to gain further information about the authorized form. (Synonyms: Investigational Product, Trial Product, Trial Medication, Clinical Supplies, and Study Drug, etc.)

Publication Source: ISPE Good Practice Guide: Booklet Labels
Publication Date: 2013

Investigational Medicinal Product (IMP)

A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorization, but used or assembled (formulated or packaged) in a way different from the authorized form, or when used for an unauthorized indication, or when used to gain further information about the authorized form.

Publication Source: ISPE Good Practice Guide: Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIPs)
Publication Date: 2013

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