EMA_欧洲药典和CEP证书介绍PPT.pdf

The European Pharmacopoeia and Your Logo certificates of suitability (CEP) Andrew McMath Ph.D. European Directorate for the Quality of Medicines (EDQM) Presented by: Andrew McMath Scientific Officer, EDQM An agency of the European Union http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2014/04/WC500165439.pdf European Directorate for the Quality of Medicines HealthCare (EDQM) A Council of Europe Directorate, based on the Convention on the Elaboration of a European Pharmacopoeia (PA, 1964) Mission: to contribute to a basic human right: access to good quality medicines and healthcare 1 The European Pharmacopoeia and certificates of suitability (CEP) European Pharmacopoeia (Ph. Eur.) •Protecting public health - one common compulsory standard. • The Ph. Eur. is the official pharmacopoeia in Europe – complemented by national pharmacopoeias for texts of interest to only one Member State. • Mandatory at the same date in 37 Member States (CoE) and the EU. • Legally binding quality standards for ALL medicinal products in its member states, i.e. raw material, preparations, dosage forms, containers must comply with the Ph. Eur. requirements when they exist. 2 The European Pharmacopoeia and certificates of suitability (CEP) European Pharmacopoeia Monographs Today • Active substances (organic, inorganic) • Excipients • Substances of biological origin and biotechnology (insulin, somatropin...) • Herbal drugs, essential oils and fats, preparations • Radiopharmaceuticals • Vaccines, sera (human, veterinary), blood derivatives • Homeopathic preparations • General monographs on dosage forms • General texts on quality issues and standard analytical methods ⇒ More than 2200 monographs 3 The European Pharmacopoeia and certificates of suit