Quality & use of medicines
The European Pharmacopoeia
The European Pharmacopoeia (Ph. Eur.) is the cornerstone for the quality control of medicines in the 39 member states that have ratified the Convention on the Elaboration of a European Pharmacopoeia. By setting harmonised quality standards, the Ph. Eur. plays a vital role in protecting public health, providing a legal and scientific framework ensuring medicines and their components meet quality requirements from their development through to production and marketing. These standards are legally binding for all manufacturers who wish to market their products in the Ph. Eur. member states. As the global landscape of medicine production evolves, the Ph. Eur. has gained recognition far beyond Europe. Its standards contribute to the development of international quality benchmarks for medicines, supporting efforts to align and harmonise quality requirements worldwide, thus promoting the safe and effective use of medicinal products on a global scale.
A year of renewal and innovation
Over the course of 2024, 202 texts (new and revised) were published in Pharmeuropa (the Ph. Eur.’s online commenting platform) for public consultation in issues 36.1 to 36.4, and a total of 28 new monographs, 11 new general chapters and 230 revised texts were adopted at the three European Pharmacopoeia Commission (EPC) sessions in March, June and November. By volunteering their time and technical skills, the Ph. Eur.’s worldwide community of experts continued to produce rich content in a variety of areas, as highlighted below. The texts – whether revised or new – incorporate recently developed analytical procedures and provide science-based and data-driven quality standards for products of high market relevance and emerging domains, thus contributing to public health protection in the Ph. Eur.’s 39 member states and the 130 countries worldwide in which they are applied. An additional 156 texts addressing further topics of interest were added to the work programme.
Our experts: a dynamic international scientific community
The work of the Ph. Eur. is driven by a dynamic international community of experts, a network comprising professionals from national authorities (e.g. pharmacopoeia authorities, official medicines control laboratories, licensing authorities and inspectorates), the private sector (pharmaceutical or chemical industries), academia, research organisations and other fields. These highly qualified individuals share their expertise and experience in the more than 60 groups and working parties to which they are appointed by the EPC and nominated for three years. In 2024, nearly a thousand experts continued to devote their time and energy to setting the Ph. Eur. public standards. These experts form the backbone of the Ph. Eur. and provide the essential link between practical experimentation and documentary standards.
Major achievements in the field of 3Rs
Since its adoption, the 1986 European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes (Council of Europe, ETS No. 123) has inspired the EPC and its experts to develop a work programme designed to replace, reduce and refine the use of animals for test purposes (the 3R principles). At EU level, the use of animals to test medicinal products is strongly discouraged under EU Directive 2010/63/EU on the protection of animals used for scientific purposes.
Elimination of the rabbit pyrogen test
In a landmark decision for animal welfare and scientific progress, the EPC decided to eliminate the rabbit pyrogen test (RPT) from its monographs during its 179th session in June 2024 and the corresponding chapter during its 180th session in November.
End to animal tests for histamine and depressor substances
The EPC decided to remove the animal tests for histamine and depressor substances during its 180th session. This decision puts an end to the use of animals in general safety tests.
Other selected achievements
Extractable elements in plastic materials
The EPC adopted a new general chapter on Extractable elements in plastic materials for pharmaceutical use (2.4.35). This chapter sets out the requirements for the control of extractable elements, ensuring the safety and quality of pharmaceutical products.
Phage therapy medicinal products
In the field of biologicals, the EPC adopted a new general chapter on Phage therapy medicinal products (5.31). This chapter provides comprehensive guidelines for the quality requirements of phage therapy products, which are gaining attention as potential treatments for antibiotic-resistant bacterial infections.
Gene therapy medicinal products
With the introduction of the general monograph on Gene therapy medicinal products for human use (3186), the EPC adopted a new approach to gene therapy, focusing on the quality and safety of these medicinal products. The aim is to provide clear and comprehensive recommendations for the development and production of these innovative therapies.
The Ph. Eur. strategy on nitrosamine contamination
At the beginning of 2024, the EPC introduced a new strategy to address N-nitrosamine impurities in Ph. Eur. monographs. This strategy aims to clarify the requirements for the detection and control of these potentially harmful impurities, ensuring the safety and quality of medicinal products. Full information on this matter can be found on the EDQM’s dedicated web page.
Joint programmes
Biological Standardisation Programme
The BSP is a joint Council of Europe/EU initiative, partly funded by the EU. Its mission is to establish reference materials for biologicals and to develop and validate new analytical procedures for their quality control, including alternative methods for the replacement of animals in laboratory experiments based on the 3R principles.
In 2024, the programme ran 25 projects in different fields, from vaccines for human and veterinary use to plasma-derived and biotechnology products. Three projects related to the establishment of reference standards were concluded during the year, one for the establishment of a new reference standard and two for the establishment of replacement reference standards (biological reference preparations – BRPs/chemical reference substances – CRSs) (see Reference standards).
The EDQM carried forward another 15 projects aimed at establishing replacement batches for existing reference standards and three others for new reference standards for biologicals.
Three ongoing projects focused on the development of new compendial methods. All are dedicated to applying the 3R principles to the field of quality control of biologicals.
International co-operation and harmonisation initiatives
The Pharmacopoeial Discussion Group
Since the integration of the Indian Pharmacopoeia Commission (IPC) in October 2023 as the fourth Pharmacopoeial Discussion Group (PDG) member, joining the Ph. Eur., the Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP), the PDG has made significant progress in three areas: its work programme, updating the ICH Q4B guideline and its annexes, and its expansion programme.
A key milestone was achieved in 2024 when the ICH Assembly endorsed the modified ICH Q4B(R1) guideline and the revised working procedure (Annex 5 of the SOP of the ICH Working Groups) on pharmacopoeial harmonisation. These texts had been prepared by the PDG and discussed with ICH members to reach a consensus. Efforts will now continue to update the interchangeability statements in all ICH Q4B annexes in the coming years.
Following the expansion in membership with the IPC, the PDG undertook to review the lessons learned from this process. Building upon this experience, the PDG launched the next phase of its global membership initiative, aimed at inviting other world pharmacopoeias to apply for membership. This will broaden its global outreach and increase the harmonisation of pharmacopoeial standards worldwide. This launch marks the beginning of the process of welcoming additional pharmacopoeias as new members over the next few years. The PDG is also evaluating and enhancing its working methods to maintain efficiency with an expanded membership.
The PDG also started a productive series of exchanges on the highly important topic of nitrosamine impurities. PDG members shared their knowledge and experience, addressed specific challenges and explored potential collaborative opportunities for the future.
The PDG signed-off on the successfully harmonised general chapter Elemental impurities (G-07) at its October meeting. The implementation of this harmonised chapter along with the application of ICH Q3D concepts promote the development of individual monographs with aligned requirements for elemental impurities among the regions of the member pharmacopoeias. With this achievement, the PDG has now successfully harmonised and continues to maintain all 31 general chapters on its work programme, including key analytical procedures such as chromatography, dissolution testing, sterility and microbiological examination. Additionally, the PDG has harmonised 48 excipient monographs and has approximately 20 new texts in its pipeline (general chapters, excipients). The PDG remains committed to promoting the recognition of harmonised pharmacopoeial standards to achieve global convergence.
Publications, databases and website
Standard Terms database
Initially drawn up at the request of the European Commission for use in marketing authorisation applications, the Standard Terms database provides users and prescribers with harmonised vocabularies to describe dosage forms, routes of administration, units of presentation, containers, closures and delivery devices for medicinal products. The lists of Standard Terms are provided in 35 languages.
The database also includes a mapped terms section, which allows users of external databases across the world to introduce and map their own terms against Standard Terms, and web services (also known as application programming interfaces) which allow registered users to extract data directly from the database for use in their own systems.
In 2024, 13 new Standard Terms concepts were added, eight were revised, and over 450 translations were added or updated. Over 3 700 new user accounts were created and the website received almost 40 000 visitors.
