European Pharmacopoeia: the compendium for quality assurance and analysis in pharmacy
Last updated: 23 December 2025
The European Pharmacopoeia (abbreviated Ph. Eur., from Latin Pharmacopoea Europaea) is a pharmacopoeia published by the European Directorate for the Quality of Medicines & HealthCare (EDQM) on behalf of the Council of Europe. It contains a comprehensive collection of monographs of medicinal substances and establishes a uniform standard for quality, storage, purity, naming, and testing of medicines and starting materials. Thus, it serves as a central regulatory framework for pharmacies in all member states of the convention, not just those of the European Union, and is incorporated into various forms in national regulations. In Germany, the European Pharmacopoeia is part of the pharmacopoeia, as specified in § 55 of the Medicinal Products Act.
The idea behind the reference work is to establish uniform and central standards in Europe that manufacturers, authorities, laboratories, and other institutions can refer to. Furthermore, the collection makes it much easier to trade in medicinal products and starting materials. Companies wishing to approve medicines also benefit from it.
Content and structure of the European Pharmacopoeia
The Ph. Eur. consists of several chapters covering various topics. Their contents are regularly updated and revised, so that they may change in detail. However, the structure of the book remains the same. It is essential to know that it is not a single, continuous work but a collection of several texts. The following overview provides a brief classification of what is included and what it entails.
General chapters deal with basic topics such as methods of testing, analytics, validation, and quality control of medicines and starting materials. General chapters are typically applicable to several monographs, thereby avoiding redundant work.
Monographs describe specific specifications for active substances, excipients, dosage forms, preparations, and materials. General monographs define overarching requirements for entire groups of substances.
Additionally, the book includes chapters on reagents and solutions, as well as extensive reference standards. For example, they define how testing systems are calibrated to obtain comparable results.
Objectives of the European Pharmacopoeia
The first edition of the European Pharmacopoeia was published in 1969. Since then, the work has been revised repeatedly. The 11th Edition has been legally binding since January 1, 2023, and is continuously updated via supplements (most recently Supplement 11.8, which has been in force since July 1, 2025). The 12th Edition is already available and will start to apply from 1 January 2026 (with further implementation steps on 1 April and 1 July 2026). However, the underlying and essential objectives have remained essentially unchanged. The pharmacopoeia is intended to harmonize quality standards in Europe (39 countries are part of the Council of Europe Convention on the Elaboration of a European Pharmacopoeia). This facilitates trade in medicinal substances and their approval across national borders. Thus, the work provides essential support for the development and market introduction of medicines.
In addition, the pharmacopoeia is intended to protect consumers. Clearly defined and established minimum standards ensure that medicinal products meet high requirements before they are placed on the market. Furthermore, the regulatory framework defines binding quality standards for testing procedures, which complement the principles of Good Laboratory Practice (GLP). Thus, the work as a whole contributes to the protection of public health.
Importance for the pharmaceutical industry
The European Pharmacopoeia holds great importance for the pharmaceutical industry. Manufacturers in all member states thereby receive clear guidelines for research, development, and production. These are legally binding requirements, since the pharmacopoeia, as in Germany, is also incorporated into national legislation in other countries.
Although this sets high standards that require investments for implementation, the work is fundamentally highly advantageous for the industry, as it considerably facilitates international approvals. For example, when German companies produce medicinal products for the domestic market, they also meet the essential requirements for all of Europe through the European Pharmacopoeia. Building on this, it also facilitates international recognition, as the WHO recognizes the European Pharmacopoeia as one of its reference pharmacopoeias. In combination with modern aseptic manufacturing processes such as blow-fill-seal technology, compliance with pharmacopoeia standards enables reliable product quality, as well as cost reduction and process rationalization. Finally, the pharmacopoeia also creates secure framework conditions, as manufacturers and authorities alike can refer to it and have a standard benchmark.
Applications in other areas
The Pharmacopoea Europaea also affects numerous other industries related to the pharmaceutical sector, as they produce raw materials or utilize active substances. The European Pharmacopoeia is particularly relevant for companies in the fields of cosmetics, chemistry, and biotechnology. In summary, the standard work provides reference standards that can also be applied in related industries.