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Parliamentary questions
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11 April 2018
E-000935/2018(ASW)
Answer given by Mr Andriukaitis on behalf of the Commission
Question reference: E-000935/2018

The Commission and the European Medicines Agency (EMA) are aware of the medical innovation in question. Ingestible sensor is a platform technology that can be co-formulated with active pharmaceutical compounds into medicinal product/medical device combinations, integrating measuring of medication adherence into oral pharmacotherapy. The Proteus Raisin System™ has been approved for marketing in the EU as a CE-marked medical device.

As regards the product Abilify (aripiprazole), which was authorised as combination product with an ingestible sensor by US Food and Drug Administration in November 2017, the Commission notes that the medicinal product in itself was authorised via the EU centralised procedure in June 2004. To date, EMA has not yet received any application for variation of marketing authorisation of Abilify to include a formulation with an ingestible sensor.

In December 2015 the EMA’s Committee for Medicinal Products for Human Use agreed(1) on the use of the Proteus® Digital Health™ Inc. technology (ingestible sensor) as a qualified method for measuring adherence in clinical trials.

(1)http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2016/02/WC500201943.pdf

Last updated: 11 April 2018Legal notice