EMA Clarifies Guidance on Genetic Therapies Classification

The European Medicines Agency issued revised guidance on classification of advanced therapy medicinal products and the information that sponsors need to submit to the agency.

Sponsors should provide the EMA with information on the active substance, any additional substances and any device or active implantable device used. They should also include a qualitative and quantitative description of the product, along with mode of action and proposed use, and the status of development, including key elements of manufacturing and quality aspects.

The Committee for Advanced Therapies will decide within 60 days of receiving an application whether a product fits the definition of an ATMP.

The guidance applies to gene and somatic cell therapies, tissue-engineered products and ATMPs that are combined with medical devices or active implantable devices.

The ATMP classification procedure gives manufacturers access to incentives, such as reduced fees for scientific advice and services offered by the EMA, including certification of quality and nonclinical data.

Read the guidance at www.fdanews.com/06-09-15-ATMP.pdf. — Kellen Owings