EUROPEAN PHARMACOPOEIA 6.0 5.8.

Pharmacopoeial harmonisation

01/2008:50800 Work on harmonisation is carried out by a well-defined but

informal process in the Pharmacopoeial Discussion Group
(PDG), in which the European Pharmacopoeia, the Japanese
5.8. PHARMACOPOEIAL Pharmacopoeia and the United States Pharmacopoeia are
associated. Information will be given in subsequent revised
HARMONISATION versions of this general chapter on items that have been
dealt with by the PDG.
This general chapter is included for guidance of users. Where harmonisation of general chapters is carried out, the
It provides information on the degree of harmonisation aim is to arrive at interchangeable methods or requirements
and consequently interchangeability of various general so that demonstration of compliance using a general chapter
chapters and monographs of the European Pharmacopoeia from one of the three pharmacopoeias implies that the same
and those of the Japanese Pharmacopoeia and United result would be obtained using the general chapter of either
States Pharmacopoeia. The chapter does not affect in any of the other pharmacopoeias. If residual differences remain
way the status of the monographs and general chapters as in harmonised general chapters, information will be given in
the authoritative reference in any case of doubt or dispute subsequent versions of this general chapter.
where compliance with the European Pharmacopoeia is
Where harmonisation of monographs is carried out, the aim
required.
is to arrive at identical requirements for all attributes of a
The European Pharmacopoeia Commission recognises the product. For some products, it can be extremely difficult to
utility of working with other pharmacopoeial bodies to achieve complete harmonisation, for example because of
develop harmonised monographs and general chapters. differences in legal status and interpretation. It has therefore
Such harmonisation is fully compatible with the declared appeared to the PDG worthwhile to approve and publish
aims of the Commission and has benefits of different monographs in which as many attributes as possible are
kinds, notably the simplification and rationalisation of harmonised. Information on any non-harmonised attributes
quality control methods and licensing procedures. Such will be included in subsequent versions of this general
harmonisation also enhances the benefits of the work of the chapter.
International Conference on Harmonisation (ICH) and the The three Pharmacopoeias have undertaken not to make
Veterinary International Co-operation on Harmonisation unilateral changes to harmonised monographs and general
(VICH) since some of the guidelines developed depend on chapters but rather to apply the agreed revision procedure
pharmacopoeial general chapters for their application. whereby all partners adopt a revision simultaneously.

General Notices (1) apply to all monographs and other texts 645