The EMA has posted the press release with details of the CVMP's meeting of 8 – 10 November 2016 (Link). General news relating to regulatory affairs includes:
- Article 35 referral for VMPs containing gentamicin presented as solutions for injection for cattle and pigs concluded: withdrawal periods for cattle (meat and milk) and pigs should be amended; subcutaneous route should no longer be recommended for cattle and pigs
Draft guidance released for consultation
- QUALITY: guideline on the chemistry of active substances.
- QUALITY: revised guideline on process validation for finished products – information and data to be provided in regulatory submissions (to be published after adoption by CHMP).
The adopted documents will be published on the EMA website in the coming weeks. More detailed minutes of the meeting can be found here (Link).
Please note that a summary list of guidance documents currently out for consultation can be found on TOPRA’s website (Link).