J Pharm Pharmacogn Res 2(Suppl. 1): S13, 2014
Special supplement with the abstract book of LATINFARMA 2013
C 003: INTERNATIONAL VALIDATION AND REGULATORY ACCEPTANCE OF ALTERNATIVE METHODS: PROGRESSES AND PROSPECTS
Eskes C.ESTIV, Switzerland.
The last years have been marked by the validation and acceptance of a number of regulatory in vitro alternative methods to animal testing adopted at international level such as by the OECD program on Test Guidelines. One of the contributing drivers is certainly the strong requests from the European Union, where the legislation on cosmetics prohibited the testing of finished cosmetic products and their ingredients on animals as well as the marketing within the European Union of cosmetics products tested or containing ingredients tested on animals. In addition to cosmetics, the European Union Regulation on new and existing Chemicals (REACH) also emphasizes the use of alternative methods, requiring the use of animal testing only as a last resort, and establishes several rules where hazard identification might be carried out using alternative methods to animal testing. In order for alternative methods to gain international regulatory acceptance, they generally need to undergo a process of independent scientific validation. In the last years, several in vitro test methods have been validated and adopted at a regulatory level in the areas of ocular and dermal hazard identification for either the full or the partial replacement of the animal test. In particular the adoption of full replacement in vitro methods is leading to new approaches of chemical safety assessment with no animal data. These new approaches bring in turn a number of questions related to the application of alternative methods for specific purposes and their possible combination in test strategies. The latest progress achieved in the formal validation, regulatory acceptance and application of alternative methods will be presented, as well as the new challenges that safety assessors and regulators may need to face regarding the regulatory application of alternative test methods.