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The Need for International Harmonisation

Globalisation and expansion in international trade present a growing need to develop global quality standards for medicines. As standards are a vital instrument for registration, market surveillance, and free movement and trade of medicines among as many countries as possible, harmonisation among the world's three major pharmacopoeias, the European Pharmacopoeia (Ph. Eur.), the Japanese Pharmacopoeia (JP) and the United States Pharmacopoeia (USP), is an important and challenging task. Within the harmonisation process, the EDQM represents the European Pharmacopoeia. All the relevant groups of experts of the European Pharmacopoeia are involved.


International Conference on Harmonisation (ICH)

In 1990, a trilateral programme, the International Conference on Harmonisation (ICH), for the harmonisation of testing of medicines among the European Union, the United States and Japan was set up. This programme aims to reduce the overall cost of pharmaceutical research worldwide by avoiding duplication of work such as the preparation of dossiers and studies, thus reducing the time required for innovative medicines to become available. This conference takes places twice a year with the location of meetings rotating among Europe, Japan and the United States


Work of the Pharmacopoeial Discussion Group (PDG)

The PDG considers proposals made by national associations of manufacturers of pharmaceutical products and excipients in order to select general methods of analysis and excipient monographs for addition to its work programme. To promote these exchanges and synergy, since 2001, the PDG has organised, upon request, hearings for representatives of the pharmaceutical and excipient industries.


Each pharmacopoeia is responsible for a programme of international harmonisation. Each text drafted by the three co-ordinating pharmacopoeia's is published for public comment at stage 4 in each of their respective forums. Please refer to the Working Procedures of the Pharmacopoeia Discussion Group (PDG), for further information.

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