Current consultations

Public consultation (MLX352): The European Commission’s proposal to harmonise the handling of variations to national licences
The Medicines and Healthcare Products Regulatory Agency (MHRA) have published a public consultation and Impact Assessment on the European Commission's proposed amendments to Directive 2001/83/EC. This will pave the way for future proposals to extend the Variations Regulation to cover variations to purely national marketing authorisations.
The closing date for responses is 17 September 2008. Consultation documents are available on the MHRA website.

Public consultation on the list of fields for paediatric clinical trials
In February-April 2008, a public consultation was conducted on draft guidance on the information concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT) and on the information to be made public by the European Medicines Agency (EMEA), in accordance with article 41 of Regulation No. (EC) 1901/2006. In this draft guidance, it was outlined that the Directorate-General for Enterprise and Industry (DG ENTR) should draw up the list of EudraCT data fields and the information on trial results for paediatric clinical trials to be made publicly available. This is the subject of the current consultation. Further Information is available at here. The deadline for comment is 30 September 2008.

Implementation of the Advanced Therapies Regulation: public consultation on good clinical practice specific to advanced therapy medicinal products.
Regulation (EC) No 1394/2007 on advance therapy medicinal products will apply from 30 December 2008. Article 4 of the Regulation requires that detailed guidance on good clinical practice (GCP) specific to advanced therapy medicinal products be drawn up. This public consultation document presents preliminary proposals to draft such guidance. Contributions to this public consultation should be sent by e-mail to entr-pharmaceuticals@ec.europa.eu, before 15 October 2008.

International Conference on Harmonisation (ICH) release E2F: Development Safety Update Report (DSUR)
The International Conference on Harmonisation (ICH) E2F Development Safety Update Report (DSUR) has been released for consultation and is intended to establish a common standard for annual safety reporting among the ICH regions.
The guideline outlines the preferred content, format and timing of periodic reporting of safety information from clinical trials. The main focus of the DSUR is data from interventional clinical trials (referred to in this document as "clinical trials") of investigational drugs including biologicals, with or without a marketing approval, whether conducted by commercial or non-commercial sponsors. Comments on this version should be emailed to ich@emea.europa.eu, the deadline for comment is December 2008. An electronic copy of the guideline can be accessed here.

National Cancer Research Institute (NCRI) consultation on elements of policies and agreements for access to samples and data for cancer research

The National Cancer Research Institute (NCRI), in collaboration with the National Cancer Intelligence Network (NCIN) and onCore UK, is soliciting views on the elements of policies and agreements for access to samples and data for cancer research. The consultation will be used to inform the development of a two part resource which includes:

• A template list of terms for an access policy for a specific Collection of data or samples, with options for tailoring to circumstance. This will differ from existing ‘guidelines’ which simply (and usefully) state principles. It will be a practical instrument for writing your own policy.
• A template Data and Material Transfer Agreement (MTA) which can again be used by anyone as a starting point.

Further details are available from the introductory letter and consultation document. Responses are welcome in any format and should be emailed to access@ncri.org.uk. Responders should feel free to answer some or all of the questions posed.

This stage of the consultation will run until 19 September 2008, following that, draft template documents will be prepared and circulated for further consultation