The recent publication by the European Medicines Agency (EMA) of a draft work plan setting out various measures for applying the 3Rs (replacement, reduction and refinement) in animal testing of medicinal products both human and veterinary has been welcomed by the British Union for the Abolition of Vivisection (BUAV).
According to the BUAV, the work plan incorporates a number of recommendations the organisation has made on steps to reduce animal research. It is particularly pleased that the EMA will be reviewing requirements for final product batch testing (e.g. rabbit pyrogen and abnormal toxicity tests), which the BUAV says are largely redundant.
While the compromise Directive on the protection of laboratory animals (8869/10) signed off by the European Parliament in September 2010 was criticised by some animal rights activists as a sell-out, it did for the first time in European Union legislation explicitly address the concept of 3Rs.
Last June the EMA brought together representatives from its Committee for Veterinary Products (CVMP) and its Committee for Human Medicinal Products (CHMP) to form an ad hoc expert group on the application of the 3Rs in regulatory testing of medicines.The draft work plan sets out an agenda for this group. It includes:
• Developing a statement that highlights accurately the position of EMA scientific committees (CXMP) on 3Rs issues.
• Reviewing and evaluating animal testing requirements in existing CXMP and international guidance to gauge their consistency with 3Rs principles.
• Reviewing final product batch testing requirements to check compliance with current Ph.Eur monographs, as well as carrying out case studies and making recommendations on the need for updates to release specifications (the EMA may also consider issuing a reflection paper on this issue).
• A preliminary analysis of the regulatory relevance of new alternatives to animal testing.
• Improving communication with stakeholders on 3Rs issues.• Developing strategies to encourage the implementation of 3Rs approaches.
Many of these proposed activities are slated for completion in 2012.
“We are pleased that the European Medicines Agency is finally taking action on animal testing,” commented BUAV senior science advisor Dr Katy Taylor.“Regulatory bodies play a critical role in providing guidance on testing to industry. We are, therefore, delighted that many of the recommendations made by the BUAV to tackle this important issue have been accepted.”