The EMA Expert Committee on ATMPs, CAT, has issued a new version of their reflection paper on ATMPs, updating the document to reflect the current thinking of the CAT on substantial manipulation (now including collagenase digestion) and on non-homologous use. Additional changes have been implemented throughout the text to clarify the existing concepts, e.g. the demarcation between vaccines against infectious diseases and gene therapy medicinal products, and the Criteria for combined ATMPs. The document is open for comments until Oct 31, 2014 and can be found here:

http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/06/WC500169466.pdf