EN PL

MHRA: PIC/S statement to European Commission's ATMP GMP Guideline

23.03.2017

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.