Current Consultations

The European Medicines Agency unveiled its new corporate website at www.ema.europa.eu. (posted 2010-07-16)

The European Medicines Agency has published a draft Guideline on quality, non-clinical and clinical aspects of medicinal products containing
genetically modified cells
(EMA/CHMP/GTWP/671639/2008). (posted 2010-07-06)

This draft guideline defines scientific principles and provides guidance for the development and evaluation of medicinal products containing genetically modified cells intended for use in humans. Its focus is on the quality, safety and efficacy requirements of genetically modified cells developed as medicinal products.

The document is available on the following webpage:

http://www.ema.europa.eu/pdfs/human/genetherapy/67163908en.pdf

Comments should be provided using this template. http://www.ema.europa.eu/pdfs/human/regaffair/submitcomment.doc
The completed comments form should be sent to .

Please note that the deadline for comments is 30 November 2010.

EMEA (posted 2009-06-23)

Web survey on EudraCT database (closed now)

Following changes to the European legislation EMEA is now able to make public some of the information in the EudraCT database which contains information on clinical trials in Europe. The set of data that will be made available has been set out in guidelines published by the European Commission.

We are interested in knowing which aspects of this information are of most interest, how people might use this information and how they will want to access it. This research will help us to design a website appropriate for the needs of the public and other interested parties. We would very much appreciate it if you could please complete our very short web survey in order to help us with our research.

Contact: Iskren Kirilov Todorov
Medical Information Sector
European Medicines Agency (EMEA)
7 Westferry Circus, Canary Wharf
London E14 4HB - United Kingdom
Tel: (44 20) 75 23 7757
Fax: (44 20) 75 23 7129
E-mail:

EMEA (posted 2009-04-08)

The European Medicines Agency (EMEA) has published a concept paper 'ON IMMUNOGENICITY ASSESSMENT OF MONOCLONAL ANTIBODIES INTENDED FOR IN VIVO CLINICAL USE' (EMEA/CHMP/BMWP/114720/2009). The document is available here:

http://www.emea.europa.eu/pdfs/human/biosimilar/11472009en.pdf

The aim of this concept paper is to ensure a more rational and systematic approach to unwanted immunogenicity assessment, investigation and prediction for this large class of biologicals by industry, academia and regulators.

Please provide any comments you may have on this concept paper to , by using this template:

http://www.emea.europa.eu/pdfs/human/regaffair/submitcomment.doc

Please note that the deadline for submitting comments is 30th of June 2009 .