Despite the low number of cannabis-derived products authorized by ANVISA, Brazil is gradually advancing its regulatory framework involving cannabis-derived products. An example of this is the recently published RDC No. 577/2021.
RDC No. 367/2020, which provides for the control of import and export of substances, plants and medicines subject to special control, including cannabis-derived products, was amended by ANVISA on 17 November through RDC No. 577/2021.
According to the changes introduced by RDC No. 577/2021, research institutions may requireSpecial Simplified Authorizationto carry out their scientific studies with the use of substances, plants, and medicines subject to special control.
Resolution No. 577/2021 changes how “research institutions” are defined, to only schools with higher or technical education and/or “fundações de apoio” (meaning a civil foundation that receives a title conferred by the federal government and generally is created by a public university). Furthermore, it is necessary that such institutions have exclusively academic teaching and research purposes. Finally, it is important to note that ANVISA can request any additional documents to issue the Special Simplified Authorization, if deemed necessary.
Less than a year ago, Brazilian health regulation started to recognize and accept cannabis-derived products. According to ANVISA’s regulation, these products may only be commercialized in pharmacies or drugstores upon medical prescription (RDC No. 327/2019). Both national and foreign companies interested in commercializing cannabis-derived products in the country are required to apply for a specific Sanitary Authorization to sell, manufacture, export or import such products.
To obtain the referred Sanitary Authorization, companies must present nine documents: (i) Authorization to Operate a Company issued by ANVISA; (ii) Special Authorization issued by ANVISA; (iii) Certificate of Good Manufacturing Practices for medicines; (iv) Good Medicine Distribution and Storage Practices; (v) technical and scientific rationale that justifies the formulation of the cannabis product and the route of administration; (vi) technical documentation of product quality; (vii) operational conditions to carry out quality control analyses in Brazilian territory; (viii) ability to receive and handle reports of adverse effects; and (ix) the concentration of the main cannabinoids present in the formulation.
To date, ANVISA has already granted seven health authorizations for cannabis-derived products, and on 4 November, two new products were authorized, which contain cannabidiol extracted from plants, instead of isolated cannabidiol in its composition.
With the changes introduced by RDC No. 577/2021, it is expected that research and development of products derived from cannabis will increase.