Educational Lecture

― ― S30 ― US FDA is a regulatory body to regulate not only drugs but also medical devices, biological products, cell therapy products, cosmetics and food additives. The largest laboratory animal users are laboratories that follow the government requirement for safety testing and the amendment of GLP regulation is interested in by laboratory animal industry. In USA, GLP is regulated by law instead of ministry order which is ruled in Japan. The summary did not include animal welfare, however the animal welfare issue is largely added and this issue is not stringently regulated in Japan, therefore US GLP Regulation amendment should be carefully observed by Japanese laboratory animal industry. The significant amendments in terms of animal welfare are as follows. Addition of attending veterinarian to the definition. The study director must defer to the attending veterinarian when decisions regarding animal welfare arise, particularly when animals are in pain or distress. The sponsor must ensure the study protocol provides for the humane care of animals. The new study director responsibilities affecting the welfare of test animals is added and the study director must consult with the attending veterinarian during review of proposed study protocols to determine potential animal welfare concerns and appropriate responses to likely contingencies. The most significant change is that FDA proposes removing the phrase “provided that such treatment does not interfere with the study”, and replacing this phrase with “as deemed necessary by the study's attending veterinarian.” FDA removes the premise for the study integrity which are appeared in Japanese regulation. FDA understands the protocol deviation is necessary to prevent a potential hazard to animal welfare or study integrity and proposes requiring that final study reports contain the names of all study attending veterinarians. US FDA proposal of GLP regulation amendment -Animal Welfare Issue-