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General chapter 5.8 Pharmacopoeial harmonisation: new concept for the Ph. Eur. 10th Edition

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European Pharmacopoeia
International harmonisation
News
13 June 2019
Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version of the general chapter on Pharmacopoeial harmonisation (5.8) which will be published in the upcoming 10th Edition (implementation date 1 January 2020). The concept of the chapter has changed significantly.

In the future, this general chapter will focus on providing general guidance for users concerning the work on harmonisation and how information is included in harmonised general chapters and monographs. This information is required in order to understand and correctly apply Ph. Eur. texts (monographs on excipients and general chapters) having undergone harmonisation by the Pharmacopoeial Discussion Group (PDG), which brings together three of the world’s major pharmacopoeias (Ph. Eur., the Japanese Pharmacopoeia and the United States Pharmacopeia, with the World Health Organization as an observer).

Therefore the revised general chapter 5.8. will no longer give details on harmonised provisions and attributes of individual texts or on any local requirements in one of the three regions. However, a complete list of harmonised texts and sign-off coversheets released by the PDG will be published on the EDQM website. These coversheets provide detailed, helpful information about harmonised parts and local requirements for all individual texts having undergone harmonisation by the PDG.

With this new approach, users will be able to retrieve the latest available information about harmonised and non-harmonised items via the EDQM website.

To date, 30 of the 31 general chapters and 46 of the 60 excipient monographs on the current work programme have been harmonised.

 

 

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