Clinical trials: Frequently asked questions

This new section provides frequently asked questions about clinical trials for medicines.

1. What are the labelling requirements for clinical trial supplies?
Investigational medicinal products (IMPs) are required to be labelled for use in clinical trials. The labelling requirements are provided in Annex 13 of Volume 4 of The Rules Governing Medicinal Products in the EU: Good Manufacturing Practices. Regulation 46 (external link) of The Medicines for Human Use (Clinical Trial) Regulations 2004 (external link) allows for a particular situation where specific trial labelling is not required. This applies to trials of marketed products being used in certain situations.

A sample of the labelling is required as part of the clinical trial authorisation (CTA) application. This sample should include the text of the labelling to be used and be provided in a format representative in terms of size of the label to be used. Samples of the actual labels to be used may be provided but are not required. Where actual samples are not included, it will be assumed that the labelling is black type on a white background unless otherwise specified.

Where labelling is not included as part of the CTA application or where the labelling to be used does not contain all the items required by Annex 13, this should be justified.

2. What is the MHRA requirement for the outline of all active trials with the same investigational medicinal product (IMP)? 
The application should include a listing of all on-going trials in the UK or any other EU Member State which commenced prior to 1 May 2004.

3. Why is only one drug product named on the Clinical Trial Authorisation approval letter for trials involving more than one investigational medicinal product?
The structure of the CTA approval letter is such that only one product can be named. Since the CTA is approved for a protocol and not for individual products, the CTA approval letter covers all IMPs listed in the application form even although only one is named on the letter. The product which appears first in Section D of the application form is the product which will be named.

4. Does the MHRA follow the CHMP Guideline on the Requirements to the Chemical and Pharmaceutical Documentation Concerning Investigational Medicinal Products in Clinical Trials?
The MHRA will follow the requirements of the guideline for all CTA applications submitted after October 1 2006.