The European Pharmacopoeia (Ph.Eur) is a pharmacopoeia published by the European Directorate for the Quality of Medicines and Healthcare (EDQM) under the auspices of the Council of Europe and all the signatory states to Treaty Number 050. The Ph.Eur is the de facto official pharmacopoeia of the European Union.
Through its monographs and general chapters, the Ph.Eur fosters public health by elaborating and communicating scientifically-valid standards required for assessing and controlling quality of medicines and excipients.
The European Pharmacopoeial Commission is the decision-making body at the EQQM responsible elaboration and maintenance of the Ph.Eur content, including revision and updates of different monographs and general chapters.
History of the European Pharmacopoeia
The Ph.Eur traces its origins to 1963, when the Public Health Committee of the Council of Europe adopted a draft Convention that lay the legal, technical and administrative foundations of the Ph.Eur. The following year, the Committee of Ministers adopted the Convention and the Rules of Procedure that would govern the European Pharmacopoeia Commission.
Between 1965 and 1966, a Technical Secretariat was expanded and a Commission appointed. Three years later, the first edition of the Ph.Eur was published, and contained just over 100 monographs. Six years later in 1975, the European Union adopted Council Directive 75/318/EEC, which made compliance with Ph.Eur monographs mandatory when applying marketing authorisations.
Now in its 10th edition, the Ph.Eur as well as the Convention has 39 signatory parties from across Europe, including the European Union, that participate and vote on sessions of the European Pharmacopoeia Commission.
Several regulations form the legal basis for the Ph.Eur. They are:
- The Convention, which was developed by the Council of Europe on the Elaboration of a European Pharmacopoeia,
- A Protocol adopted in 1994 that also amended the Convention with the aim of laying preparations for the accession of the European Union and defining the powers of the European Union and its member states within the European Pharmacopoeia Commission,
- EU Directives 2001/83/EC and 2001/82/EC, as amended, on medicines for human and veterinary use, which maintain the mandatory character of Eur monographs when applying for marketing authorisation.
Organisation of the European Pharmacopoeia
The Ph.Eur is arranged into different sections, including
- General Chapters
- General Monographs
- Monographs for Vaccines, Immunosera, Radiopharmaceuticals, Sutures, Herbal products and Homeopathic products
- Specific monographs on Active Pharmaceutical Ingredients and Excipients, and
- Specific Monographs on Dosage Forms
The 10th Edition of the Ph.Eur (including Supplement 10.5) contains 2447 monographs (including dosage forms), 378 general texts (including general monographs and methods of analysis) and about 2800 descriptions of reagents.
All these standards are designed to meet the information needs of scientists and managers involved in research and quality control of medicines, regulatory authorities and those involved in the manufacture of medicinal products or individual components.
The Ph.Eur is available as a single reference volume that covers all relevant articles featured. The 10th Edition was released in July 2019 and will be updated with eight periodic supplements over the following three years (10.1 to 10.8).
Available in either English or French, the print version contains a subscription key (EPID code) that allows access to online archives. The compendium can also be accessed online via a licence (individual or shared access).
The 2021 subscriptions to the European Pharmacopoeia Supplements 10.3-10.5 are available on the EDQM WebStore.
The European Medicines Agency: European Pharmacopoeia
Quality standards of the European Pharmacopoeia