EDQM/USP Monograph Harmonization

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] The European Directorate for the Quality of Medicines and Healthcare (EDQM) and the United States Pharmacopeial Convention (USP) have jointly decided to halt the 2008 “Prospective Harmonization Pilot Project” initiated to develop harmonized monographs and reference standards for drug substances still under patent. The joint press release notes that the collaboration “revealed complexities” as USP and EDQM attempted to harmonize their respective processes, and that “”both organizations remain fully committed to pharmacopoeial harmonization and will continue to collaborate…in a less formal manner.” [Editor’s Note: For more on USP’s monograph modernization and harmonization efforts, see IPQ “Monthly Update” July 2014, pp. 30-43.]
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