CAT monthly report for February 2010

Dear Interested Parties to the Committee for Advanced Therapies (CAT),

As some of you may be aware, at the end of each CAT plenary, the CAT Secretariat drafts a Meeting Report where it disseminates key elements of the work of the CAT. We wanted to make you aware of this document in order to aid you with the attainment of up-to-date information on the decisions made by the CAT. Please click here:

http://www.emea.europa.eu/pressoffice/cat.htm

You may consider keeping the above webpage in your favourites section for rapid access.

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Regulatory Intelligence SPIN

The framework for the regulation of medicines grows more complex every day. The development of new product types, the harmonisation of requirements and the addition of new countries to the EU all have resulted in an environment where it’s becoming increasingly hard to predict how the regulatory agencies will view applications.

At the same time we see more and more information becoming available.

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European Medicines Agency consultation: Questions and Answers on Gene therapy (EMA/CHMP/GTWP/212377/2008)

The European Medicines Agency has published a Questions and Answers document on Gene therapy (EMA/CHMP/GTWP/212377/2008), which is available on the following webpage:

http://www.ema.europa.eu/pdfs/human/genetherapy/21237708en.pdf

This document will be regularly updated on the basis of received comments and questions. Should you have any, please send them to GTWPsecretariat@ema.europa.eu

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