ISPE Works with Associations on Annex 1 Implementation Timelines
ISPE continues to work with a group of industry associations to assist the European Union (EU) and the European Medicines Agency (EMA) with implementation of revision of Annex 1, Manufacture of Sterile Products. Annex 1 is a key document in "The rules governing medicinal products in the European Union", which contain guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use. The current Annex 1 is being reviewed to facilitate implementation of the principles of relevant ICH guidelines, to extend the underlying concepts to include new areas of technology and processing not previously covered and also to clarify areas that have been highlighted as ambiguous due to the age of the document.