EMA releases guidance on advanced therapy medicines
Clarification of legal basis for advanced medicine product classification with a view to establishing controls
The European Medicines Agency (EMA) has released guidance for pharmaceutical manufacturers about the detailed information to be declared should they want to classify their products as advanced therapy medicines.
Its officials must agree a medicine is gene therapy, somatic-cell therapy, tissue-engineered or a combined medicine, under the European Union’s advanced therapy medicinal products regulation (EC) No 1394/2007, for it to be sold as an advanced therapy pharmaceutical. This allows EMA, working with the European Commission, to determine whether or not a given product meets scientific criteria defining these products.
EMA wants to clarify the controls for this fast developing branch of the pharma sector. In its paper, it stressed it needed information on a proposed advanced therapy medicine’s active ingredient and structure; finished product characteristics, including delivery method; proposed use, including an ‘in-depth discussion on how the product works and what data are there to support the mechanism’; and development status – ‘key elements of manufacturing, quality aspects (including description and level of manipulations on cells and tissues, when applicable)’.
The paper also clarifies the legal basis for advanced medicine product classification and advises on how to deal with borderline cases where classification can be difficult.
Comments are invited before 31 July 2012 to advancedtherapies@ema.europa.eu.