European Pharmacopoeia: the compendium for quality assurance and analysis in pharmacy
Last updated: 17 December 2025
The European Pharmacopoeia (in German Europäisches Arzneibuch and 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, whose German edition is published by the German Pharmacopoeia Publisher. 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 is a central regulatory framework for pharmacy for all member states of the convention, not only of the European Union, and is incorporated in various forms into national regulations. In Germany, the European Pharmacopoeia is part of the pharmacopoeia according to § 55 of the Medicinal Products Act.
The idea of the reference work is to create uniform and central standards in Europe to which manufacturers, authorities, laboratories, and other institutions can refer. 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 devoted to different topics. Their contents are regularly subject to updates and revisions, so that they may change in detail. However, the structure of the book remains the same. It is important to know that it is not a single, continuous work but a collection of several texts. The following overview provides a rough classification of what is included and what it is about.
General chapters deal with basic topics such as methods of testing, analytics, validation, and quality control of medicines and starting materials. General chapters are usually valid for several monographs, thus 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.
In addition, there are 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 undergone several extensive revisions, with the 11th edition (Ph. Eur. 11.0, EDQM 2023) most recently coming into force. However, the underlying and essential objectives have hardly changed. 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 act in a complementary way to 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 is of great importance to 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 greatly facilitates international approvals. For example, when German companies produce medicinal products for the domestic market, they simultaneously meet essential requirements for all of Europe through the 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 common benchmark.
Applications in other areas
The Pharmacopoea Europaea also affects numerous other industries related to the pharmaceutical sector because they produce raw materials or use active substances. The European Pharmacopoeia is relevant, for example, 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.