Clinical research on animal pharmaceuticals, first rule setting by the government

The Ministry of Agriculture, Forestry and Fisheries has notified prefectural governments and the Japan Veterinary Medical Association of standards for appropriately conducting clinical research on veterinary drugs that do not violate the Pharmaceutical Affairs Law.

This is the first time that the government has established rules for clinical research on animal drugs. The aim is to ensure transparency and create an environment suitable for drug development, amid concerns about research that violates the law due to the lack of clear rules. It also revealed that there are concerns about research that violates the law, such as a case in which a male professor at Tottori University’s Faculty of Agriculture provided an unapproved investigational drug for treating cancer in dogs and cats to a total of 791 veterinary hospitals nationwide.

The notification issued on April 20, 2019 sets out eight standards for conducting “appropriate clinical research” using unapproved drugs without violating the Pharmaceutical Affairs Law. In order to be recognized as “appropriate clinical research”, ethical review by a neutral review committee, the number of cases, the frequency of use of unapproved drugs, and the implementation period within the necessary range are set rationally. , must meet all the requirements. It also asks pet owners to explain the treatment plan to them and obtain their consent, and to ensure the transparency of the research, including proper record keeping. The Ministry of Agriculture, Forestry and Fisheries recommends consulting if you are unsure whether your product falls under the Pharmaceutical Affairs Law.

In an interview with the Yomiuri Shimbun, Dr. Yuki Ujimasa, DVM, MS, who runs a veterinary drug consulting company, said, “It is very significant that the standards have been clarified. Furthermore, if laws are enacted, the transparency of clinical research will increase.”