Anvisa authorizes research with cannabis derivatives at UFRN

The National Health Surveillance Agency (Anvisa) granted a special authorization for the Federal University of Rio Grande Norte (UFRN) to conduct scientific experiments with products derived from Cannabis, the marijuana plant. The permission goes to the university’s Instituto do Cérebro (ICe-UFRN) and involves pre-clinical research projects to evaluate the efficacy and safety of combinations of phytocannabinoids in the management of signs and symptoms associated with neurological and psychiatric disorders. According to Anvisa, pre-clinical research is not carried out on humans. The authorization process was based on a meeting of the collegiate board of Anvisa, which took place on the last December 7th, and favorably judged an appeal by UFRN against the rejection of the initial request for research with Cannabis. According to the regulatory agency, “despite its use for medicinal purposes for thousands of years, there is still an important scientific gap on the potential, mechanisms of action and effects of the use of Cannabis sp. in the human body”. Since 2019, an Anvisa resolution has authorized the manufacture and importation of products with Cannabis for medicinal purposes in Brazil. According to the organ, it is estimated that more than 100,000 patients undergo some type of treatment using Cannabis. In addition, more than 66,000 Cannabis-based medicines were imported in 2021. Around 50 countries have already regulated the medicinal and industrial use of the marijuana plant and Hemp. Last month, the Federal Council of Medicine even published a rule that expanded restrictions on the prescription of products derived from Cannabis. After a negative reaction from professionals, researchers and patients, the medical authority suspended the measure. Obligations In order to grant the so-called Simplified Special Authorization for Teaching and Research Establishments (AEP), Anvisa determined that UFRN must comply with a series of mandatory criteria, which are: 1) The research institution’s building and installation project must be submitted to the assessment by Anvisa prior to the beginning of the research; 2) The University must forward to Anvisa the records of the individual follow-up of each project under development through half-yearly and annual reports; 3) A conclusion report must be submitted to Anvisa at the end of the research project, containing complete information on the use and destination of the Cannabis sp. plant; 4) In case of product disposal, it must be inactivated by autoclaving and subsequently disposed of by a company specialized in the disposal of chemical and biological waste through the incineration process; 5) Definition of specific requirements regarding access control to the facilities where research will be carried out.

Agência Brasil