美剂乐：欧洲辅料管理与发展.pptVIP

Overview Registration of excipients in the EU GMP status for excipients Harmonization Future development of excipients Members of European Pharmacopoeia European Pharmacopoeia - Observers Authorisation Procedure Apart from the national authorisation procedures, two new authorisation procedures have been created on the basis of regulations and directives of the European Commission: the centralised and the decentralised authorisation procedures. Centralised authorisation procedure Here authorisation of medicinal products is not granted by a national agency but by the European Commission in Brussels. The organisational procedure is handled by the EMEA in London. Decentralised authorisation procedure These are mutual recognition procedures. The marketing authorisation already granted by one EU Member State is to be recognised by the licensing agencies of other Member States within 90 days, unless there are major objections against doing so. Composition of the Medicinal Product Excipients must be listed, specifying their common name, their quantity and the use and reference to any relevant standard. When the common name is not sufficient to indicate functional specifications, the brand name with commercial grade should be specified. In the case of excipients presented as a mixture of compounds, details as to the composition should be provided in qualitative and quantitative terms. Pharmaceutical Excipients Substances, other than the active ingredient, which have been appropriately evaluated for safety and are included in a drug delivery system to: aid in the processing of the drug delivery system during its manufacture; protect, support or enhance stability, bioavailability, or patient acceptability; assist in product identification; or enhance any other attribute of the overall safety and effectiveness of the drug during storage or use Specifications and routine tests Excipients described in the European Pharmacopoeia o