Both documents were originally issued in 1992 and have not been revised since then. With significant changes in GMP and in veterinary product manufacture and technologies a revision is hence overdue. Especially following the release of the technical requirements of ICH Q8, Q9, Q10 and Q11 there has been extensive technology progress and additionally, progress in the development of new products, e.g., ATMPs, cell products, or tissue engineered products. Along with this goes the separation of the EU GMP Guide in 2005, in GMP for medicinal products (Part I) and for active substances (Part II) which is also not reflected in the current annexes, so far.
What is planned?
For Annex 4 manufacture of veterinary medicinal products other than immunologicals:
For Annex 5 manufacture of immunological veterinary medicinal products:
Both papers are currently open for stakeholder consultation. Comments should be sent to ADM-GMDP@ema.europa.eu until 9 January 2022 using this template. The proposed date for the release of the draft guidelines is March 2023. A drafting group will be established by GMP/GDP Inspectors Working Group and the PIC/S WG on VMP representing the PIC/S committee with a rapporteur and supporting experts from other EU member regulatory authorities and from non-EU PIC/S participating authorities.
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