European Pharmacopoeia Launches All-Digital 12th Edition
Summary
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has launched the all-digital 12th Edition of the European Pharmacopoeia (Ph. Eur.). This new edition is available on a redesigned platform with a 365-day licence, marking a significant shift in how users access official quality standards for medicines in Europe.
What changed
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has announced the launch of the 12th Edition of the European Pharmacopoeia (Ph. Eur.), transitioning to an entirely digital format. This new edition is accessible via a redesigned, user-friendly online platform, which includes a new 365-day licensing model. The Ph. Eur. standards are legally binding in member states and are crucial for the quality control of medicinal products.
Pharmaceutical companies and drug manufacturers will need to obtain a licence to access the new platform and its content. The EDQM is offering a free webinar on July 1st and 3rd, 2025, to demonstrate the platform's features. Users are encouraged to consult the provided links for licensing information and to register for the webinar to understand how to best utilize the new digital resources for compliance with quality standards.
What to do next
- Obtain a licence for the new European Pharmacopoeia Online platform.
- Review the features of the redesigned platform to ensure continued compliance with quality standards.
- Consider attending the free webinar on July 1st or July 3rd, 2025, for guidance on using the new platform.
Source document (simplified)
1 / 2 24 June 2025, Strasbourg, France All-digital 12th Edition marks a new era for the European Pharmacopoeia The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe is proud to announce the launch of the 12th Edition of the European Pharmacopoeia (Ph. Eur.). This edition – much more than just another number – ushers in a new, all-digital era for the primary source of official quality standards for medicines and their ingredients in Europe, now available on a redesigned, user-friendly platform enabling users to stay connected with a new 365-day licence. This is a milestone in the evolution of the Ph. Eur. It builds on the proud tradition of scientific excellence, rigorous quality standards and international collaboration that is deeply embedded in the DNA of the Ph. Eur. and is exemplified in the dynamic and diverse community of almost 1 000 experts worldwide that contribute to its contents. Users can consult our brochure at https://go.edqm.eu/PhEurRenewals to find out how to obtain their licence, or visit the European Pharmacopoeia Online at https://go.edqm.eu/PhEurOnline to access all Ph. Eur. texts currently in force and discover the platform’s new features designed to meet their professional needs. To present the full possibilities of the new Ph. Eur. platform, the EDQM has scheduled a free, two-part webinar entitled “Unlocking the potential of the European Pharmacopoeia Online” on 1 July 2025, with an additional session added on 3 July due to high demand. Users who want to know more are strongly encouraged to register. Full information on the European Pharmacopoeia is available at https://go.edqm.eu/PHEUR: • the 12th Edition and its publication schedule; • the Ph. Eur. work programme; • how to participate in the work of the Ph. Eur; • an overview of related products and services. The Ph. Eur. has been contributing to providing access to quality medicines for hundreds of millions of people worldwide for over 60 years. Ph. Eur. standards form a legal and scientific basis for the quality control of medicinal products and their ingredients, throughout their life cycle, supporting the pharmaceutical industry and healthcare systems. These standards are legally binding within the Ph. Eur. member states, as specified in the Council of Europe Convention on the Elaboration of a European Pharmacopoeia (Ph. Eur. Convention) and in European Union and national pharmaceutical legislation. All producers of pharmaceuticals must therefore apply them to market their products in the signatory states of the Ph. Eur. Convention. The Ph. Eur. is furthermore recognised worldwide as a quality benchmark. Contact: Evangelos Tasopoulos, Communications and Events Division, EDQM, Council of Europe Tel.: +33 (0)3 90 21 53 90 – E-mail: evangelos.tasopoulos@edqm.eu Note for the Editor: Further information is available on the internet site www.edqm.eu. The European Directorate for the Quality of Medicines and HealthCare (EDQM) is a structural part of the Council of Europe. It traces its origins in the statute to the Convention on the Elaboration of a European Pharmacopoeia, opened for signature in 1964. Today, 39 member states of the Council of
2 / 2 Europe have ratified the convention and more than 30 countries from all over the world participate in the EDQM activities as observers. The EDQM promotes and protects human and animal health by developing standards and supporting their implementation. It is active in four major policy areas: medicines, pharmaceutical care, substances of human origin and consumer health. EDQM staff represent almost 30 different nationalities and its work is supported by a network of nearly 2 000 experts from all over the world. An international organisation set up in 1949, the Council of Europe works to promote democracy, human rights and the rule of law continent-wide. It also develops common responses to social, cultural and legal challenges in its 46 member states.
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