Conclusion of Prospective Harmonisation Pilot Project



  • Theresa Laranang-Mutlu
    Media Relations, USP
    + 1 301 816 8167;
  • Caroline Larsen Le Tarnec
    Public Relations Division, EDQM,
    Council of Europe
    +33 (0) 3 88 41 28 15; caroline.letarnec@edqm.

29 April 2015, Rockville (USA) and Strasbourg (France) — In July of 2008, the European Directorate for the Quality of Medicines and HealthCare (EDQM), on behalf of the European Pharmacopoeia (Ph.Eur.) and the U.S. Pharmacopeial Convention (USP), initiated the Prospective Harmonisation Pilot Project to develop harmonised monographs and reference standards for drug substances still under patent. As an outcome of this project, four monographs (on Celecoxib, Montelukast Sodium, Rizatriptan Benzoate, and Sildenafil Citrate) were elaborated using a modified Ph. Eur. P4 procedure; eleven reference standards were established in support of these four monographs.

The two sponsors, Merck and Pfizer, provided identical dossiers to the EDQM and the USP. Verification of the proposed analytical methods was performed in both EDQM and USP laboratories and adoption of the four texts was synchronised between the Ph. Eur. Commission and USP. USP and EDQM were pleased to have the opportunity to work together with the sponsors of these monographs and sincerely appreciate their contributions.

The collaboration, however, revealed complexities as USP and EDQM attempted to align their respective processes which ultimately did not provide added value to the harmonised standards published. After a thorough evaluation of the outcome of the pilot project, and a critical review of the resources utilised, USP and EDQM jointly decided to officially conclude the Prospective Harmonisation Pilot Project.

USP and EDQM plan to continue efforts to maintain similar standards for these monographs. Both organisations remain fully committed to pharmacopoeial harmonisation and will continue to collaborate on prospectively harmonised monographs in a less formal manner.