Abstract
The scale of laboratory animal production in China has been increasing year by year. For the purpose of standardizing management, protecting the welfare of laboratory animals, China has established a relatively complete legal system for them. China has also formulated legal concepts such as “laboratory animals”, “laboratory animal welfare,” and “cruelty to laboratory animals”. Research and development of chemicals, drugs, food, and cosmetics are areas where animal experiments are legally required. The management model of laboratory animals can be summarized as government supervision and third-party certification management. The core pillar of government supervision is the licensing system and the certification system. China has also established a self-supervision system for laboratory animal institutions such as monitoring and ethical review. In the future, it should continue to improve the existing system and strengthen law enforcement.
Highlights
The scale of laboratory animal production in China has been increasing year by year
For foreign pharmacopoeia, veterinary pharmacopoeia, paid pharmacopoeia, or feed regulations, or where the government’s drug administration in the producing country has approved the production and sale, but it does not contain the Chinese pharmacopoeia, veterinary pharmacopoeia, veterinary drug specifications and professional standards, it is necessary to carry out a medicinal effect test, and the medicinal effect test is performed on animals
Application review process, the Ministry of Science and Technology issued the “Implementation Plan for the Reform of Separation of Licenses and Certificates for Laboratory Animals in Free Trade Zones” in December 2019, eliminating more than 10 types of supporting materials that need to be submitted when applying for a license, in order to improve the efficiency of administrative review, though this may create loopholes for review
Summary
China's regulatory documents enumerate the main animal names in the definition of laboratory animals in addition to the "Interim Regulations on the Management of Laboratory Animals in the Health System"(1983). According to other legal documents, laboratory animals are defined as those individuals that are “captive bred, in environments where microorganisms are controlled, having a traceable genetic background or source of origin, bred for scientific, teaching, production, testing and other research purposes."9 "Source" refers to genetic background and microbial control.. China's regulatory documents enumerate the main animal names in the definition of laboratory animals in addition to the "Interim Regulations on the Management of Laboratory Animals in the Health System"(1983).. According to other legal documents, laboratory animals are defined as those individuals that are “captive bred, in environments where microorganisms are controlled, having a traceable genetic background or source of origin, bred for scientific, teaching, production, testing and other research purposes."9 "Source" refers to genetic background and microbial control.. It goes without saying that laboratory animals for research and teaching are worthy of special explanation in China. The Chinese medicine industry has attracted much attention or controversy because it uses a large number of laboratory animals. There are many biological products that derive their raw materials from the organs of animals.
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