PDA Letter Article

Industry Awaits Annex 1 Revision

by Walter Morris, PDA

Four Months After PDA EU Annex 1 Workshop, Revision Still Eagerly Anticipated

At the 2017 PDA Europe Revision of Annex 1 workshop, European regulators estimated a summer release of the long-awaited draft revision of the EMA guidance on GMPs for the manufacture of sterile drug products, now delayed for a later date. Andrew Hopkins, MHRA, and Beate Reutter, Landesamt fuer Soziale Dienste (Germany), spoke on behalf of EMA, providing glimpses into areas of the guidance that are being updated. The workshop took place on June 12 in Berlin and was a preconference session to the 2nd PDA Europe Annual Meeting.