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16 May 2014

First draft finished product monograph with chemically defined active substance published for comment

Deadline for comments: 30 September 2014

In March 2014, the European Pharmacopoeia Commission decided, based on the results of a pilot project, to start working on monographs for finished products containing chemically defined active substances. The first draft monograph, covering Sitagliptin phosphate tablets (2927), has been published for comments and is available in the online forum Pharmeuropa.

Although the Commission's decision to be more active in the area of monographs on finished products will expand the scope of the European Pharmacopoeia (Ph. Eur.), it is not a change in paradigm. Monographs on finished products exist already in the Ph. Eur., but have been limited to specific types of products such as vaccines or certain biologicals in the past. Finished product monographs will be elaborated according to the same general principles as for other monographs in the Ph. Eur. to ensure the same high scientific quality.


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