The need for international harmonisation
Globalisation and expansion in international trade have created a growing need to develop global quality standards for medicines.
As pharmacopoeial standards are a vital instrument for registration, market surveillance, and free movement and trade of medicines among regions and countries, the European Pharmacopoeia is actively engaged in a number of international harmonisation initiatives such as:
- bilateral harmonisation efforts with other pharmacopoeias;
- an informal structure referred to as the Pharmacopoeial Discussion Group (PDG), together with the Japanese Pharmacopoeia and the United States Pharmacopeia, with the World Health Organization (WHO) as an observer;
- in the WHO initiative to draft and maintaining the "Good Pharmacopoeial Practices" guidelines (GPhP) that shall serve as a basis for worksharing and collaboration between the pharmacopoeias of the world and at the International Meeting of World Pharmacopoeias (IWMP).
The EDQM represents the European Pharmacopoeia within these initiatives. All the relevant groups of experts and working parties of the European Pharmacopoeia are involved.
Work of the Pharmacopoeial Discussion Group
The PDG considers proposals made by associations of manufacturers of pharmaceutical products and excipients in order to select general methods of analysis and excipient monographs to be added to its work programme. To promote these exchanges and synergy, the PDG has, since 2001 and upon request, organised hearings for representatives of the pharmaceutical and excipient industries.
All topics currently on the programme of pharmacopoeial harmonisation have been assigned to one of the three participating pharmacopoeias, which takes the lead in co-ordinating the drafting of the respective text. Each text is published for public comment in the respective forums of the three pharmacopoeias.
Please refer to the September 2017 Working procedures of the Pharmacopoeia Discussion Group for more information.
"Good Pharmacopoeial Practices"
The International Meeting of World Pharmacopeias (IMWP) was first convened in 2012 under the auspices of WHO, to facilitate information exchange and discussion of international co-operation and harmonisation among the world’s pharmacopoeial organisations. Since then, sessions of the IWMP take place regularly with representatives from national, regional and international pharmacopoeias committed to working towards greater harmonisation and strengthening WHO's role when developing global standards for the production and testing of medicines. The principal achievement of the IMWP is the development of the "Good Pharmacopoeial Practices" guidelines to favour prospective harmonisation facilitated by WHO.
The GPhP were developed by the pharmacopoeial representatives under the auspices of the WHO Expert Committee on Specifications for Pharmaceutical Preparations, benefiting from its well-established international standard-setting processes and procedures. These processes include an international consultation process, which enables the participation of all stakeholders and users in the development process.
The primary objective of the GPhP is to define approaches and policies in establishing pharmacopoeial standards with the ultimate goal of harmonisation. They describe a set of principles that provide guidance for national, regional and international pharmacopoeias that facilitates the appropriate design, development and maintenance of pharmacopoeial standards. Although the principles may also apply to other products, the focus of the GPhP is substances for pharmaceutical use and finished products.
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, the ICH has gradually evolved, to respond to the increasingly global face of drug development. Its mission is to achieve greater harmonisation worldwide to ensure that safe, effective and good quality medicines are developed and registered in the most resource-efficient manner. 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, the overarching governing body of the ICH. The EDQM is an observer of the ICH Association and contributes to the development of ICH guidelines, for example on the control of elemental impurities and the development and manufacture of active pharmaceutical ingredients.