“While only few advanced therapies have been authorised so far, there are many products in the pipeline as reflected by the volume of pre-authorisation activities in the Committee for Advanced Therapies (CAT). The committee will continue its efforts to enhance the development and availability of new medicines in this area,” said Paula Salmikangas, the new chair of the European Medicines Agency’s (EMA) Committee for Advanced Therapies on the day of her election.

The committee elected Dr Salmikangas as new chair for a three-year mandate at its February 2014 meeting. She succeeds Christian Schneider, who had chaired the committee since its creation in 2009. A Finnish national, Paula Salmikangas has qualifications in biochemistry and in cell and molecular biology. She has been senior researcher at the Finnish Medicines Agency (Fimea) since 2003. She was previously the vice-chair of the CAT, a position she held since the establishment of the committee. The CAT is the committee at the EMA responsible for assessing the quality, safety and efficacy of advanced-therapy medicinal products (ATMPs).

In 2013, two new ATMPs were recommended for marketing authorisation by the Agency’s Committee for Medicinal Products for Human Use (CHMP). This brings to four the total number of ATMPs recommended for approval by the CHMP since the legislation on advanced therapies became operational in 2009. These innovative medicines are derived from gene therapy, cell therapy or tissue engineering and can offer groundbreaking new opportunities for the treatment of disease and injury. Medicines in all categories of ATMPs have now been approved in the European Union with one gene therapy (Glybera in 2012), one cell therapy (Provenge in 2013) and two tissue-engineered products (ChondroCelect in 2009 and MACI in 2013).

In 2014, the CAT forecasts that three to four initial applications for marketing authorisation of advanced therapies will be submitted to the EMA. These applications should include the three types of ATMPs.

The CAT delivers scientific recommendations on ATMP classification. This procedure gives companies developing innovative new treatments the opportunity to check whether their product can be considered an ATMP and can therefore benefit from the regulatory pathway and the available scientific guidelines for these types of medicine. This procedure often constitutes the first contact between the Agency and developers of ATMPs.


Posted on the EMA website on 14 February 2014