EC launches fresh consultation on advanced therapy medicines

Published: 24-Jan-2013

Concerns that current legislation had failed to secure authorisations for combined products


The European Commission is considering another reform of the European Union (EU) advanced therapy regulation, asking the pharma sector for its views on a range of concerns. In a consultation document, Brussels said it was concerned that the current legislation, which was last updated in 2007, had failed to secure EU market authorisations for combined medicinal products. ‘No application for a combined advanced therapy medicinal product has been submitted to the European Medicines Agency (EMA) yet,’ said the Commission.

Another concern is that the regulation allows the use of advanced therapy medicinal products in hospitals for individual patients without a general marketing authorisation. ‘The so-called hospital exemption provides for flexibility to address the situation of individual patients; however, a too large application of this exemption may discourage the application for marketing authorisations,’ the Commission said.

The consultation will be open until 31 March 2013 – comments should be sent by e-mail to sanco-advancedtherapy-report@ec.europa.eu

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