EMA press release for May meeting of the CVMP

8 May, 2015

The EMA has posted the press release with details of the CVMP's meeting of 5 – 7 May 2015 (Link). General news relating to regulatory affairs includes:

  • Two new community referrals were started relating to concerns over antimicrobial resistance:
    • All VMPs containing a combination of lincomycin and spectinomycin for oral administration to pigs and poultry 
    • All VMPs containing colistin in combination with other antimicrobial substances to be administered orally
  • The Committee held an interested parties meeting to discuss the following topics:
    • Application of 3Rs principles in the authorisation of medicines
    • Building blocks for an improved pharmacovigilance system
    • How to avoid duplication and redundancy of environmental risk assessment within the EU authorisation system
    • SPC harmonisation – focus on withdrawal periods
    • Response preparation to CVMP consultations
    • Progress on VICH GL52 on bioequivalence: blood level bioequivalence study