During the last months, we reported several times about the current activities of the EMA and European Commission relating to the new GMP Guideline document for Advanced Therapy Medicinal Products ( e.g. “European Commission: Draft Guideline GMP for ATMP open for stakeholder consultation” and “GMP for ATMP – two Public Rounds of consultation and still a Need for Discussion?”) and the ongoing discussion between the authorities, developers of ATMPs, manufacturers and other ATMP related organisations.
http://www.gmp-compliance.org/gmp-news/pic-s-statement-to-european-commissions-atmp-gmp-guideline