Regulatory News

European Medicines Agency consultation: Draft guideline on quality aspects on the isolation of candidate influenza vaccine viruses in cell culture

The European Medicines Agency has published a Draft guideline on quality aspects on the isolation of candidate influenza vaccine viruses in cell culture (EMA/CHMP/BWP/68803/2010).

The document is available on the following webpage:

http://www.ema.europa.eu/pdfs/human/bwp/6880310en.pdf

The scope of this draft guideline is to provide guidance for the isolation on cell culture of any potential influenza vaccine virus intended for cell culture or egg-based influenza vaccine manufacture.

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Committee for Advanced Therapies (CAT) Update

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.ema.europa.eu/pressoffice/cat.htm

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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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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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