The International cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medical Products (VICH) has, as reported by the EMA, released guidance on determining a toxicological acute reference dose (ARfD) for residues of veterinary drugs. This guidance will take effect in the European Union in November 2017.

European Medicines Agency (2016). VICH GL54. Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish an acute reference dose (ARfD). 8 December 2016. EMA/CVMP/VICH/699251/2010. Committee for Medicinal Products for Veterinary Use (CVMP). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2016/12/WC500218314.pdf

 

The above items were taken from the January/February 2017 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here)

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