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How Ph. Eur. texts are elaborated
The European Pharmacopoeia Commission allocates the work on monographs to specially constituted groups of experts and working parties. The member of these groups come from regulatory authorities, official medicines control laboratories, pharmaceutical and chemical manufacturers, universities and research institutions. All monographs are verified experimentally and submitted to public consultation before inclusion in the European Pharmacopoeia.
How Ph. Eur. texts are updated
The texts are regularly updated, taking into account the changes in marketed products and scientific progress.
The European Pharmacopoeia Commission has decided to schedule its work on active substances so that monographs are produced a few years before the patent expiry date, thus making it possible to assess dossiers on generics on the basis of existing monographs and related certificates of suitability.
The principles of elaboration of monographs are continually adapted to keep pace with regulatory needs in the public health area (licensing, control and inspection authorities), with industrial constraints, and with technological or scientific advances.
Three types of revision can be envisaged:
- systematic revisions to update the most obsolete monographs; a special revision programme was set up in 2005 to reinforce the control of impurities for substances produced by chemical synthesis;
- revisions to harmonise monographs on similar substances;
- revisions on a case by case basis, to satisfy requests received by the European Pharmacopoeia Commission either when the monograph is found to be unsatisfactory in some respect or when the manufacturing method for substances on the market has been changed. This revision may be made at the request either of a public health authority or of an industrialist, if necessary through a representative association.
PA/PH/SG (00) 66 DEF Guide for the work of the European Pharmacopoeia
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