What is the European Pharmacopoeia 9th Edition and why is it important
The European Pharmacopoeia (Ph. Eur.) is a collection of standards for the quality of medicines and their ingredients. It is published by the European Directorate for the Quality of Medicines & Healthcare (EDQM), which is part of the Council of Europe. The Ph. Eur. covers more than 2,800 monographs and 370 general chapters, as well as reference standards and certificates of suitability.
The 9th Edition of the Ph. Eur. was released in July 2016 and became effective in January 2017. It reflects the latest developments in a dynamic and ever-changing pharmaceutical world, with more than half of its content being new or revised compared to the 8th Edition[^2^]. The 9th Edition also includes supplements that are published every six months and become applicable on the same date[^3^]. The Ph. Eur. is available in print, online and downloadable versions.
The Ph. Eur. is important because it sets harmonised quality standards for medicines and their ingredients in 38 European countries, as well as the European Union and the European Economic Area. It also facilitates international trade and cooperation by ensuring that medicines comply with common requirements across different regions and markets. The Ph. Eur. contributes to public health protection by safeguarding the quality, safety and efficacy of medicines.
To access the online version of the Ph. Eur., you need to subscribe to it on the EDQM webstore[^1^]. You can also consult the draft monographs for public enquiry on Pharmeuropa Online[^1^] and check the publication schedule for each new edition or supplement[^1^]. For more information about the Ph. Eur., you can visit the EDQM website[^1^] or watch this video interview with Dr Susanne Keitel, Director of the EDQM[^2^].
The Ph. Eur. is constantly updated and revised to keep pace with scientific and technological advances, as well as regulatory and market needs. Some of the main topics covered by the 9th Edition and its supplements include:
Biological products and biotechnology: new and revised monographs on vaccines, blood products, monoclonal antibodies, gene therapy products, etc.
Herbal medicines: new and revised monographs on herbal drugs, herbal drug preparations, herbal medicinal products, etc.
Chemical substances: new and revised monographs on active substances, excipients, impurities, etc.
General methods: new and revised chapters on analytical techniques, microbiological methods, biological assays, etc.
General notices: new and revised sections on definitions, abbreviations, symbols, units, etc.
The Ph. Eur. also provides guidance on various aspects of quality control and quality assurance, such as good manufacturing practices (GMP), good distribution practices (GDP), good laboratory practices (GLP), etc. The Ph. Eur. is complemented by other EDQM publications and services, such as the European Pharmacopoeia Reference Standards (Ph. Eur. RS), the Certification of Suitability to the monographs of the European Pharmacopoeia (CEP), the Official Control Authority Batch Release (OCABR), etc.
The Ph. Eur. is developed and maintained by a network of experts from national authorities, academia, industry and other stakeholders. The Ph. Eur. Commission is the decision-making body that adopts the monographs and chapters of the Ph. Eur., based on the scientific work of its groups of experts and working parties. The Ph. Eur. Commission also cooperates with other pharmacopoeias and international organisations to promote harmonisation and convergence of quality standards for medicines. ec8f644aee