The role of pharmacopoeias in international harmonisation

The last 30 years have seen profound changes in the organisation of the European people and the regulation of medicinal products. Thirty years ago, each country had its own regulations, with all the possible variations between the various national pharmacopoeias. Today, the European Pharmacopoeia, with its 1500 monographs and nearly 250 general methods of analysis, has replaced the major part of these national regulations: the European Pharmacopoeia Convention has now been signed by 27 states(1) and by the Commission of the European Communities; moreover 16 European and non-European countries(2) and the WHO have observer status. Close relations are maintained with the licensing authorities of the European Economic Area, where integration is developing via the implementation of common directives and guidelines on medicines for human and veterinary use. In addition, in 1990, the European Pharmacopoeia co-founded, with the Japanese Pharmacopoeia and the US Pharmacopoeia, the Pharmacopoeial Discussion Group (PDG); this group is working assiduously for harmonisation at world level.