The EMA has posted the press release with details of the CVMP's meeting of 7 – 9 July 2015 (Link). General news relating to regulatory affairs includes:
The Committee adopted various documents for public consultation:
A new concept paper to review the use of extended-spectrum penicillins in animals in the European Union: development of resistance and impact on human and animal health (Link).
A draft revised guideline on requirements for the production and control of IVMPs (Link).
A draft reflection paper on methods found suitable within the EU for demonstrating freedom from extraneous agents of the seeds used for the production of IVMPs (Link).
A concept paper on the need for revision of the veterinary note of guidance on manufacture of the finished dosage form (Link).
A concept paper on the need for a single veterinary note for guidance on the chemistry of active substances (EMA/CVMP/QWP/107359/2015, to be published on the EMA website).
EMA has reminded applicants of the mandatory use of electronic application forms (eAFs) for centralised procedure applications from 1 July 2015, available on the esubmissions website (Link). The European Commission has also updated NtA Volume 6 to reflect this (Link)
Validation checklists used by the EMA to validate initial MAAs for immunological and pharmaceutical VMP are available on the EMA website for applicant’s to use for pre-submission review of their submissions (Link).
