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Why We Need Harmonisation
Globalisation and expansions in international trade present further challenges as there is a growing need to develop global quality standards. Harmonisation among the world’s three major pharmacopoeias, the European Pharmacopoeia, the Japanese Pharmacopoeia and the United States Pharmacopoeia, is currently an important and challenging task, as these standards are a vital instrument in the registration, market surveillance, and free movement and trade of medicines among as many countries as possible.
Composition of the Pharmacopoeial Discussion Group (PDG)
The EDQM represents the European Pharmacopoeia in the trilateral programme for harmonisation of testing of medicines among the European Union, the United States and Japan through the International Conference on Harmonisation (ICH). This trilateral programme, set up in 1990, aims to reduce the overall cost of pharmaceutical research world-wide by avoiding duplication of work (preparation of dossiers and studies) and thus reduce the time required for innovative medicines to be made available to patients, especially for diseases of great medical need.
PDG Work Programme
Monographs and general methods of analysis proposed by national associations of manufacturers of pharmaceutical products are selected for convergence and harmonisation among the three pharmacopoeias. Since 2001, the PDG has organised at each session a hearing for representatives of the excipient and pharmaceutical industries, to promote exchanges and synergy. Each pharmacopoeia is therefore responsible for a programme of international harmonisation. It can work towards this goal by consulting users through public surveys in the various forum publications or, if necessary, by organising international conferences with the other two pharmacopoeias and the parties concerned to reach a consensus. All the relevant groups of experts of the European Pharmacopoeia are working on this programme.
Calendar 2008
This group meets regularly (twice a year), with the location of the meetings rotating among Europe, Japan and the United States. The PDG will hold its next meeting in November 2008 in Brussels, Belgium.
Downloads
PDG Meeting, 1-5 June 2008 Pharmacopoeial Discussion Group (PDG) meeting, Portland, USA, 1-5 June 2008
PDG State of Work State of Work on International Harmonisation (June 2008)
PDG Projected Timetable Projected timetable for publication and implementation of texts (November 2007)
PDG Working Procedures PDG Working Procedures (signed off document Nov. 2007) English only
Useful Links
PDG Co-Founders
PDG Statement IH Policy PDG Statement of International Harmonisation Policy (July 2004)
WHO World Health Organisation
ICH International Conference on Harmonisation
SJP Society of Japanese Pharmacopoeia
USP United States Pharmacopoeia
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