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
