Division II.6.3.5.2.3
United Kingdom
Guidance on the approach towards developmental toxicity testing is described in VICH GL32: Studies to evaluate the safety of residues of veterinary drugs in human food: developmental toxicity testingf1. This provides for a tiered approach, with testing to be undertaken initially in a single species (rat). Any departures from established guidance shall be justified and the impact discussed.
Annotations
Footnotes
- f1
-
VICH GL32 Studies to evaluate the safety of residues of veterinary drugs in human food: developmental toxicity testing (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001479.jsp&mid=WC0b01ac058002dd37).