Problems and Discussion on Cannabidiol-based Pharmaceuticals in China
Objective:Cannabidiol is one kind of cannabinoids present in cannabis plants.European and American countries have approved its use for the treatment of epilepsy.In China,cannabidiol,as an isomer of tetrahydrocannabinol,is regulated as a first class psychotropic drug and has not yet been marketed.The aim of this study is to explore regulatory issues in the development,production,and marketing of cannabidiol drugs,propose feasible regulatory approaches,and promote the research and application of such drugs in China.Methods:By reviewing the"Regulations on the Administration of Anesthetic Drugs and Psychotropic Drugs"and the"Notice on the Administration of Experimental Research on Anesthetic Drugs and Psychotropic Drugs",as well as local regulations in Yunnan and Heilongjiang provinces,combined with the addiction and medical value of cannabinoid,this study explored the regulatory issues in hemp cultivation,experimental research projects and production of cannabinoid drugs,and proposed targeted suggestions.Results and Conclusion:Cannabinoid drugs have important clinical value in neuropsychiatric disorders and are not addictive.At present,regulatory regulations have certain limitations on the approval of experimental research projects for cannabidiol drugs.There is a certain gap in the supervision of hemp cultivation.It is recommended to balance the accessibility and risk of drug abuse based on the existing experience in China,and promote the development of cannabidiol drugs in a planned and systematic manner,promote their research and clinical application in China,and assist in the clinical treatment of neurological and psychiatric disorders.