The approach is preceded by the fact that three-quarters of all drug candidates are failing in the first or second clinical phase for different reasons. Therefore, it is not necessary to carry out developmental toxicological studies on 1,500 rats and 1,000 rabbits at these stages which could be done instead with in vitro studies using corresponding cell cultures from animals. Only in the third phase, when the first two drug testing phases have been successful, the corresponding studies to investigate pregnant damage would be conducted.
Therefore, the tests would be pushed back and a superfluous animal consumption would be stopped in the cases, in which the medicinal product is not further developed due to exclusion criteria.
Source (in Dutch):
https://nos.nl/artikel/2310962-veel-minder-proefdieren-nodig-door-nieuwe-regels-voor-farmaceuten.html
https://english.cbg-meb.nl/about-meb
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Tuesday, 26 November 2019 20:01
Netherlands planning new regulations for the reduction of animal testing for drug development Featured
According to Dr. Peter Theunissen from the Dutch Medicines Evaluation Board (CBG), in the foreseeable future, much fewer animals are used for the evaluation of the developmental toxicology effects of drugs. On behalf of the government, the CBG monitors the quality of pharmaceuticals and is involved in the preparation of guidelines for the pharmaceutical industry.
Dr. rer. nat.
Menschen für Tierrechte - Tierversuchsgegner Rheinland-Pfalz e.V.