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Parliamentary questions
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20 August 2018
Answer given by Mr Andriukaitis on behalf of the European Commission
Question reference: E-003922/2018

It is widely recognised that advanced therapeutic medicinal products (ATMPs) have the potential to address some of today's unmet medical needs and provide novel solutions to diseases such as cancer or neurodegenerative disorders. For example, the European Medicines Agency (EMA) recently issued a positive opinion on the first two marketing authorisation applications for chimeric antigen receptors (CAR) T-cells medicines in the EU(1). These belong to a new generation of personalised cancer immunotherapies that are based on collecting and modifying patients’ own immune cells to treat their cancer.

The regulation of this field is complex. The protection of patients requires a rigorous examination of risks and benefits while ensuring that obligations of developers are realistic. However, that does not mean that further legislative changes are necessary. With the 2007 Regulation (EC) 1394/2007(2) the field is already governed by a clear and specific framework addressing the particular challenges of this product category.

At the same time, the application of the existing provisions can be optimised. The joint action plan between the Commission and the EMA, mentioned by the Honourable Members, serves this purpose. For example, the guidelines on good manufacturing practices have already been delivered, providing clear benefits to the sector. Other actions of the plan are still ongoing or in preparation.

(1)http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/06/news_detail_ 002983.jsp&mid=WC0b01ac058004d5c1
(2)Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13.11.2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).

Last updated: 22 August 2018Legal notice