The five Rs: refinement, reduction, replacement. A regulatory revolution.

ABSTRACT

Regulatory requirements have frequently been cited as a major reason for the continued performance of batch control tests using animals. Although such claims have not always been justified regulatory authorities and associated organizations such as the pharmacopoeial committees have sometimes been slow to respond to emerging knowledge and the potential of novel techniques. The regulatory approach to quality control tests in the wider context of quality assurance and total quality management is discussed together with the role which the regulatory authorities can play in promoting reduction in the use of animal based tests and the opportunities which exist for them to encourage manufacturers to explore other approaches. The need for caution on the part of regulatory authorities in requesting additional data which would necessitate further animal testing is stressed and the concept is proposed of a formal review of the benefits of animal testing applied on a batch basis whenever a marketing authorization is issued or renewed. The types of animal test most amenable to deletion or modification are considered together with those tests which present particular problems. Specific proposals are made for an immediate reduction in the numbers of animals used.