EU's IMP definition open for consultation

The European Commission is inviting comments on a guidance proposal on the definitions of Investigational Medicinal Products and Non-Investigational Medicinal Products, by October 1.

The guidance aims to facilitate clinical trials across the European Union. The draft guidance states: "to facilitate clinical trials in the case of multicenter trials carried out in more than one member state it is necessary to have a common understanding of the definition of an investigational medicinal product."

The existing definition of an IMP is provided by EC directive 2001/20/EC, Article 2 (d): "an active substance or placebo being tested or used as a reference in a clinical trial, [...] used or assembled 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." The guidance includes a requirement that all IMPs must be recorded on the EU's clinical trials database.