Guidance

European Commission consults on non-commercial clinical trials

The European Commission has released for consultation a new draft guidance document on specific modalities for non-commercial clinical trials. The commission is required to do this under Recital 11 of Directive 2005/28/EC. The guidance describes which good clinical practice measures member states may introduce to take account of specific needs of non-commercial clinical trials whilst still ensuring the safety of the patients involved in the trials.

A non-commercial clinical trial is defined by the commission as research conducted without the participation of the pharmaceutical industry¹. It notes that sponsors should carefully consider the following criteria for defining a non-commercial clinical trial before indicating its non-commercial status:

• the trial sponsor should be a university, hospital, public scientific organisation, non-profit institution, patient organisation or a researcher, and the ownership of the data should belong to this sponsor;
• there should be no agreement between the sponsor and any third party allowing the data to be used for regulatory or marketing purposes;
• the design, conduct, recording and reporting of the clinical trial should be under the control of the sponsor; and
• the studies should not be part of the development programme for a marketing authorisation of a medicinal product.

If any of the criteria of the trial alter during the duration, the sponsor should inform the competent authority of the relevant member state and the ethics committee.

The guidance suggests that a simplified investigational medicinal products dossier may be submitted and cross referral to another sponsor's investigational medicinal product dossier may be allowed. Guidance is also given on the traceability and labelling of investigational medicinal products and what documentation needs to be submitted.

Consultation on the draft guidance is open until 1 October 2006.

Investigational medicinal products

The commission has also released a proposal for guidance on the definition of non-investigational and investigational medicinal products². The document is to provide a common understanding of the definition of an investigational medicinal product in order to facilitate multi centred trials carried out in more than one member state.

According to Directive 2001/20/EC, Article 2(d), an investigational new product must be “being tested or used as a reference in a clinical trial, including products already with a marketing authorisation but used or assembled in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form”. If a product meets these criteria it can be considered an investigational new product.

Non-investigational medicinal products are substances used in a clinical trial, such as medication for preventative, diagnostic or therapeutic reasons, but are not the subject of investigation. The guidance specifically covers categories of non-investigational medicinal products with examples and provides definitions of a clinical trial and a medicinal product.

Comments should be made by 1 October 2006.

References

1. Draft guidance on specific modalities for non-commercial clinical trials referred to in commission directive 2005/28EC laying down the principles and detailed guidelines for good clinical practice, 28 July 2006, http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/new.htm

2. Definition of Investigational Medicinal Products (IMPs) - Definition of Non Investigational Medicinal Products (NIMPs), 28 July 2006, http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2006/07_2006/def_imp_2006_07_27.pdf