The BUAV, together with our colleagues at the European Coalition to End Animal Experiments (ECEAE) have submitted comments to the European Medicines Agency on its revised concept paper on replacing animal testing. The Agency responded to requests, including from the ECEAE, that it needs to update its guidance from 1997. The Agency has now drafted a concept paper which outlines how a draft guideline may look. In response to requests to broaden the scope of the guideline to include veterinary as well as human medicines, the Agency updated the concept paper in July this year.
We are pleased to see the Agency update its guideline on how industry may replace animal testing. We had felt there to be a lack of encouragement on this issue. We hope the new guideline will make the process clearer by which industry may show that an alternative method is valid and safe to use. The ECEAE is, however, concerned about how long the revision of the guideline is taking. A revised guideline was requested by the ECEAE in 2009 and the concept paper (a precursor to an actual updated guideline) was finally open for comment in March 2011. This second round of comments finished at the end of September 2012. It may be many more months before a draft guideline is available.