The European Pharmacopoeia (Ph.Eur) is a pharmacopeia published by the European Directorate for the Quality of Medicines and Healthcare (EDQM) on behalf of the Council of Europe and all signatory nations to Treaty Number 050. The Ph.Eur supports public health through its monographs and general chapters, which develop and communicate scientifically valid criteria for assessing and controlling the quality of medicines and excipients. It was founded on July 22, 1964, when the Convention on the Development of a European Pharmacopeia became available for signature. It is currently being developed and published by the Council of Europe's European Directorate for the Quality of Medicines and Healthcare (EDQM).
The European Pharmacopoeia includes a series of general monographs on medication manufacture, general methods of substance and medicine analysis, and certain basic dosage form standards. The pharmaceutical business may employ the analysis methods for substances and medicines that are not described in the pharmacopoeia.
The majority of the Ph. Eur. consists of quality standards, which are mentioned in both the monographs and general methods parts. Quality standards include analytical procedures for identifying substances and evaluating their quality and quantitative strength. The section on impurities is perhaps the most important aspect of an active substance's quality standards.
Two Council of Europe entities are the European Pharmacopoeia Commission and the European Directorate for the Quality of Medicines and Healthcare (EDQM). The European Pharmacopoeia is acknowledged as defining the official quality standards of the EU in directives and possesses legal authority inside the EU. The European Pharmacopoeia Commission is housed within the EDQM. The Commission is in charge of the Pharmacopoeia's general chapters and monographs. The practical work is done by multiple professional groups.
A concept known as the Certificate of Suitability (CEP) was developed by the EDQM. A maker of an active ingredient may request such a certificate from the EDQM. A thorough description of the substance's chemical synthesis and any known or potential impurities should be included in the application. All of the articles covered in the Ph.Eur are available as a single reference volume. Eight recurring supplements (10.1 through 10.8) will be added to the 10th edition, which was released in July 2019.An EPID code (membership key) that provides access to online archives is included in the print version, which is offered in both English and French. Additionally, the compilation is accessible online via licensing (single or shared access).
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 (with Supplement 10.5) contains 2447 monographs (containing dosage forms), 378 general texts (including monographs and techniques of analysis), and around 2800 reagent descriptions.
All of these standards are intended to address the information demands of scientists and managers active in pharmaceutical research and quality control, regulatory bodies, and those involved in the production of medical products or specific components.