Elaboration

The principles for elaborating the general chapters and monographs of the European Pharmacopoeia are continually updated to keep pace with the regulatory requirements of licensing, control and inspection authorities in the public health sector, with technological and scientific advances and with industrial constraints.

The European Pharmacopoeia Commission allocates the work to specially constituted groups of experts and working parties.
All monographs are verified experimentally and submitted for public consultation before they are included in the European Pharmacopoeia. The technical guides for elaboration of monographs can be consulted on the EDQM’s website and are available here. These documents are used as a guide by authors of monographs and provide users of the European Pharmacopoeia (especially industry, licensing authorities and official medicines control laboratories) with the principles for the elaboration of monographs.

Under the P4 procedure, the European Pharmacopoeia Commission schedules its work on active substances and related finished products to ensure that monographs are available 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 to the Monographs of the European Pharmacopoeia.

Revisions

The texts are updated regularly taking into account changes in marketed products and scientific progress.

Monographs and general chapters can be revised:

  • on a case-by-case basis to satisfy requests received from an authority or industry, for example. Such requests are made when some aspects of the monograph are found to be unsatisfactory or when the manufacturing method for marketed substances has been developed.
  • to harmonise monographs on similar substances,
  • when the Ph. Eur. implements new regulations or guidelines (for example the REACH regulation, the ICH Q3D guideline),
  • to update obsolete texts (systematic changes).

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