The principles for elaborating the general chapters and monographs of the European Pharmacopoeia are continually adapted to keep pace with the regulatory needs of licensing, control and inspection authorities in the public health area, and with technological and scientific advances and with industrial constraints.
Under the P4 procedure, 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 of the Monographs of the European Pharmacopoeia.
The European Pharmacopoeia Commission allocates the work 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.
The texts are updated regularly taking into account changes in marketed products and scientific progress. Three types of revision take place:
systematic revisions updating the most obsolete monographs
revisions harmonising monographs on similar substances
revisions on a case-by-case basis to satisfy requests received by the European Pharmacopoeia Commission either from a public health authority or from industry associations. Such requests are made when the monograph is found to be unsatisfactory in some respects or when the manufacturing method for marketed substances has been changed.
More information on Pharmeuropa and Pharmeuropa Bio & Scientific Notes
Technical Guide for the Elaboration of Monographs of the European Pharmacopoeia (2011)
Download all Technical Guides
Guide for the work of the European Pharmacopoeia (PA/PH/SG (11) 54 DEF)
Elaboration/Revision of a Monograph (Procedure 1) (Updated Sept. 2013)
Elaboration of a Monograph (Procedure 4) (Updated Sept. 2013)