ANVISA authorizes National Scientific Research with Cannabis

Following ANVISA´s Q&A on Medical Cannabis for Clinical Investigations published last year, the agency now authorizes national scientific research with cannabis-derived products. The authorization granted will allow the Brain Institute of the Federal University of Rio Grande do Norte (ICe-UFRN) to conduct pre-clinical research to evaluate the efficacy and safety of cannabinoids in the management of signs and symptoms associated with neurological and psychiatric disorders.

"Despite its use for medicinal purposes for thousands of years, there is still an important scientific gap about the potentialities, mechanisms of action and effects of cannabis sp. use", ANVISA says. "The absence of accurate scientific information may imply inaccuracy that often prevents the determination of the effectiveness of Cannabis-derived products in curative or pain-easing therapies or other undesirable symptoms arising from various human diseases".

Amongst others, the following is mandatory for the granting of the authorization:

• Plans of the buildings and facilities of the research Institution must be submitted to ANVISA for evaluation prior to the beginning of the research;
• Definition of specific requirements regarding the access controls of the facilities where the research will be carried out.

Finally, it is emphasized that the approval only aims to allow the generation of raw material in the national territory - produced under strict control conditions and for strict use in the scope of scientific research.

For more information please see Anvisa autoriza pesquisa científica nacional com produtos derivados de Cannabis.