European Pharmacopoeia Commission Sets Priorities for Next Three Years

November 29, 2016

The commission approved future plans, appointed members, and adopted texts during its November 2016 session.

The European Pharmacopoeia Commission

on Nov. 29, 2016 that, during its 156th session, the commission approved its working program activities until November 2019, which include actively involving observers and reviewing current processes and procedures. The commission also adopted 14 new texts and appointed chairpersons and members during the session.

New and revised texts that were adopted at the session will become effective January 1, 2018 and will be published in supplement 9.3 of the European Pharmacopoeia. The following texts were adopted:

  • Three monographs elaborated under the P4 procedure (single-source products): Rupatadine fumarate (2888); Human coagulation factor IX (rDNA) powder for solution for injection (2994) and on Etanercept (2895)

  • One monograph on Radiopharmaceutical preparations: sodium pertechnetate (99mTc) injection (accelerator-produced) (2891)

  • Two new monographs on antibiotics: Tacrolimus (2244) and Tylosin phosphate for veterinary use (2802)

  • Three new monographs on gases: carbon monoxide intermix (5% in nitrogen) (2904), Methane intermix (2%) in nitrogen (2905), and Acetylene intermix (1% in nitrogen) (2903)

  • Monographs on: Nicardipine hydrochloride (2776); ammonium carbonate for homoeopathic preparations (2916) and Magnolia biondii flower bud (2742)

  • Two new general chapters: In vivo assay substitution with in vitro methods for quality control of vaccines (5.2.14) and Chemical imaging (5.24.).

Also adopted were 52 revised monographs, including eight dosage form monographs and 11 revised general chapters. The commission also revised its implementation strategy for the International Council for Harmonization (ICH) Q3D guideline on elemental impurities during the session.

Source: