INTERNATIONAL NEWS FEBRUARY 2017

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Martina Schüssler-Lenz elected as new chair of Committee for Advanced Therapies

Mandate to cover three years

At its February meeting, the European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT) elected Dr Martina Schüssler-Lenz as its new chair, for a three-year mandate. She follows Paula-Anneli Salmikangas, who had chaired the Committee since February 2014.

A German national, Dr Martina Schüssler-Lenz is the Deputy Head of the Advanced Therapy Medicinal Products Section at the Paul-Ehrlich Institute (PEI) in Langen, Germany, and has been vice-chair of the CAT since March 2014.

“An ambitious CAT work plan and increased workload lies ahead of us. Therefore, my aim is to come up with adequate regulatory strategies to cope with this increasing workload, which include streamlined discussions in the Committee’s meetings and even closer interaction with the committee for human medicines, the biologics and the scientific advice working parties, as well as other committees and working parties,” says Dr Martina Schüssler-Lenz.

“I am also committed to expanding the role of the CAT as a global player in the field of advanced therapies.”

The CAT is responsible for assessing the quality, safety and efficacy of advanced therapy medicinal products (ATMPs) and following scientific developments in the field. ATMPs are medicines for human use that are based on genes or cells. They offer ground-breaking new opportunities for the treatment of disease and injury. The Committee prepares a draft opinion on each ATMP application submitted to EMA, before the Committee for Medicinal Products for Human Use (CHMP) adopts a final opinion on the marketing authorisation of the medicine concerned.

 

Clinical data for two more medicines now available online

First publication of clinical data corresponding to a withdrawn application

The European Medicines Agency (EMA) has published clinical data for two additional medicines on its clinical data websiteExternal link icon. This follows the launch of the website on 20 October 2016 and is in line with the Agency’s policy on the publication of clinical data.

The clinical data for Aripiprazole Mylan correspond to a withdrawn application for a marketing authorisation for a generic product to treat schizophrenia, and to prevent and treat moderate to severe manic episodes in patients with bipolar I disorder. These are the first clinical data published supporting an application that was subsequently withdrawn.

Palonosetron Hospira is a generic product indicated to prevent nausea and vomiting caused by chemotherapy.

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