The European Pharmacopoeia (Ph. Eur.) general chapter on Pharmacopoeial harmonisation(5.8) provides users with general guidance on the work of the EDQM in this field and details of the information included in harmonised Ph. Eur. general chapters and monographs. This information enables users to understand and correctly apply Ph. Eur. texts (monographs on excipients and general chapters) harmonised 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).
With the entry into force of the 10th Edition of the Ph. Eur. on 1 January 2020, general chapter 5.8 will no longer provide details of the individual non-harmonised provisions and attributes of each text or of specific local requirements in the three regions. Instead, this information will be available on the EDQM website. Users can now access two comprehensive tables containing details of all texts on the PDG work programme and all related sign-off coversheets released by the PDG:
The harmonisation status of general texts is available here.
The harmonisation status of excipient monographs is available here.
With this new approach, users will be able to quickly and easily retrieve the most up-to-date information on the harmonisation status of pharmacopoeial texts via the EDQM website. To date, 30 of the 31 general chapters and 46 of the 60 excipient monographs on the current PDG work programme have been harmonised.