The need for international harmonisation
Globalisation and expansion in international trade have prompted a growing need to develop global quality standards for medicines.
As pharmacopoeial standards are a vital instrument for marketing authorisation, market surveillance and free movement and trade of medicines amongst regions and countries, the European Pharmacopoeia (Ph. Eur.) is actively engaged in a number of international harmonisation initiatives including:
- bilateral harmonisation efforts with other pharmacopoeias;
- working with the Japanese Pharmacopoeia and the United States Pharmacopeia in an informal structure called the Pharmacopoeial Discussion Group, which has WHO as an observer (see below);
- and elaborating and maintaining WHO “Good Pharmacopoeial Practices” that serve as a basis for work-sharing and collaboration between the pharmacopoeias of the world. This work is carried out by the International Meeting of World Pharmacopoeias.
The EDQM represents the European Pharmacopoeia within these initiatives. All the relevant groups of experts and working parties of the European Pharmacopoeia are involved.
The Pharmacopoeial Discussion Group (PDG)
After assessing proposals from associations of manufacturers of pharmaceuticals and excipients, the PDG selects candidate general methods of analysis and excipient monographs for inclusion on its work programme. Since 2001, these exchanges have been made easier by ad hoc meetings for representatives of the pharmaceutical and excipient industries organised, upon request, by the PDG.
Each topic on the international harmonisation programme is assigned to one of the three participating pharmacopoeias, which takes the lead in coordinating the drafting of the text in question. The harmonised text is then published for public comment in the respective forums of the three pharmacopoeias.
Once agreement has been reached by all three pharmacopoeias, the harmonised text is signed-off by the PDG.
The PDG’s mandate is to harmonise the technical content of the text. Each pharmacopoeia is then free to adapt the text to its own style and format. This includes the freedom to adjust the reference materials and general methods described.
Please refer to the Working procedures of the Pharmacopoeia Discussion Group as revised in Sept. 2017, and PDG Statement of Harmonisation policy for further information.
Information on texts harmonised by the PDG
General chapter 5.8 Pharmacopoeia harmonisation provides basic guidance for users on the PDG’s harmonisation efforts and how information is included in harmonised Ph. Eur. texts (excipient monographs and general chapters). Ph. Eur. users need this information in order to understand and correctly apply any texts harmonised by the PDG.
Details about the status of individual texts and agreements reached on them by the three pharmacopoeias are shown in the tables and documents linked below.
Good Pharmacopoeial Practices (GPhP)
The International Meeting of World Pharmacopeias (IMWP) first convened in 2012 under the auspices of WHO. The idea was to facilitate the exchange of information and discussions among the world’s different pharmacopoeias and to foster international cooperation and harmonisation. Since 2012, the IMWP has taken place regularly and is attended by representatives from national, regional and international pharmacopoeias, all committed to working further towards harmonisation and strengthening WHO's role in the development of global standards for the production and testing of medicines. The IMWP’s biggest achievement to date has been the development of GPhP to promote prospective harmonisation, facilitated by WHO.
The GPhP are developed by pharmacopoeial representatives under the auspices of the WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP), whose well-established international standard-setting processes and procedures are particularly valuable in this context. One of these processes, international consultation, gives all stakeholders and users the opportunity to become involved in the development process.
The primary objective of this work is to define approaches and policies for establishing pharmacopoeial standards in general, but particularly from a harmonisation perspective. The set of principles laid down in the GPhP therefore provide guidance on the design, development and maintenance of pharmacopoeial standards for national, regional and international pharmacopoeias. Although the principles may also apply to other products, these good practices focus primarily on pharmaceutical ingredients and finished products.
The GPhP chapters on monographs for compounded preparations and on monographs on herbal medicines can be found here (respectively Annex 6 and Annex 7 of the 52nd report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations).
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
The ICH is a unique organisation that brings together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since it was founded in 1990, the ICH has gradually evolved in response to the increasingly global face of drug development. The ICH's mission is to promote and support harmonisation worldwide to ensure that safe, effective, and high quality medicines are developed and registered, in the most resource-efficient manner. This harmonisation is achieved through the development of ICH guidelines via a process of scientific consensus, with regulatory and industry experts working side-by-side.
The ICH Assembly brings together all Members and Observers of the ICH Association as the overarching governing body of the ICH. The EDQM is an observer of the ICH Association and contributes to the development of relevant ICH guidelines, e.g. related to the control of impurities, the development and validation of analytical methods and on continuous manufacture.