1 999165438+1October1day, the US Food and Drug Administration issued and implemented the Quality Management Standard for Non-clinical Research of Drugs. Refers to the normative documents on the organization and management, working methods and related conditions of laboratories engaged in the planning, design, implementation, management, supervision and recording of experimental research.
Related requirements
According to the requirements of the US Food and Drug Administration: 1, chemical raw materials, preparations and biological products that have not been marketed in China since 2007.
Effective components, effective parts and their preparations extracted from plants, animals, minerals and other substances that have not yet been marketed in China, and effective components and their preparations extracted from traditional Chinese medicines and natural medicines.
The non-clinical safety evaluation of new drugs of traditional Chinese medicine injections must be carried out in laboratories that have passed GLP certification and meet GLP requirements.
Reference to the above content: Baidu Encyclopedia -GLP Certification