From IMPD to IND – same but different

by Rajeswara Rao Pannem

The aim of an investigational new drug application (IND) is to obtain approval from FDA to perform clinical trials of an investigational medicinal product (IMP) in humans in the US. The IND follows the CTD structure developed by ICH and requires very detailed product and development data such as information of manufacture, data from nonclinical studies, previous clinical studies if any related to the IMP (Figure 1). It is also required to provide comprehensive source documentation including study reports. It is mandatory to submit an IND in the eCTD format starting from May 2018.

IMPD as a central document for drug development from early on

Theo Tiko and Annegret Wiedemann reflect on their experience with most recently prepared IMPDs. 

The Investigational Medicinal Product Dossier (IMPD) is a central piece of Investigational Medicinal Product (IMP) related documents required for approval of clinical trials by the competent authorities in the EU. An IMPD is required for IMPs to be used in a clinical study, regardless of whether it is the test product itself, a reference product already authorised or a placebo.