Anvisa completes 23 years: a timeline about the agency and medicinal cannabis

By João R. Negromonte

The National Health Surveillance Agency (Anvisa), an autonomous agency linked to the Ministry of Health, was created on January 26, 1999. The institution aims to preserve the health of the population through health control and regulate medicines and health products that will enter the market or are already part of it. 

Throughout its 23 years, the issue of the medicinal use of cannabis only began to be discussed by the agency in 2014, after a group of mothers (participants in the documentary “Ilegal, a vida não espera”) started to mobilize to obtain authorization from the agency and import plant-based medications, which until then were still little known to us Brazilians. 

From there, a movement began to seek studies, research, and successful clinical cases related to the medicinal properties of cannabis in the treatment of some pathologies. Several studies were discovered that had been little observed by Brazil until then. 

In 2015, the Resolution of the Collegiate Board (RDC) 17/2015 was published, the first rule created for the exceptional import of cannabidiol, that is, only for specific cases. In the same year, as soon as the rule came into effect, companies began to request authorization from the agency to cultivate the plant for medicinal and research purposes. 

The following year, in 2016, according to Anvisa data, the medicinal use of cannabis was included in the list of plants and substances under special control of the Portaria 344, de 1998, from the Ministry of Health. This update enabled the registration of medicines based on derivatives of the plant. Also in 2016, the list of products with cannabidiol for simplified import authorization was updated. 

Already in 2017, the first medication made from cannabis was approved in the country: Mevatyl. It is recommended for people with Multiple Sclerosis (MS), showing effective results in treating the disease, a benefit that no other conventional medication had been able to provide for patients with the pathology. 

In the same year, the Resolution of the Collegiate Board (RDC) 156/2017 was published, which included cannabis in the list of Brazilian Common Denominations (DCBs), codes and numbers established by the agency to name drugs and active principles approved by the federal agency. 

After two years with no significant changes in the rules for the medicinal use of cannabis in Brazil, in 2019, according to data from the health organization, the agency took off on this issue, creating a series of new regulations on the plant, including: 

• Completion of the Preliminary Regulatory Impact Analysis (AIR) Report on the topic;
• The Collegiate Board approves proposals for public consultations related to the regulation of medicinal cannabis (technical requirements for the cultivation of the plant for medicinal and scientific purposes and registration and monitoring of medicines); Public consultations 654 (registration and monitoring requirements) and 655 (cultivation requirements) are published in the Official Gazette of the Union (D.O.U.) on June 13, 2019;
• Sending Directed Consultations to 29 entities related to the topic, requesting contributions on the regulatory proposals;
• The Collegiate Board approves the holding of a Public Hearing to collect subsidies on the proposals under consultation;
• The agency discusses the regulation of the medicinal use of cannabis in Brazil at Public Hearings in the Chamber of Deputies and the Senate;
• A Public Hearing at Anvisa brings together directors and 240 participants to discuss the subject;
• The balance of the 1,154 contributions received during the Public Consultations is disclosed;
• The analysis of the contributions received during the Public Consultations, Public Hearing, and Directed Consultations is carried out;
• The regulation proposals are consolidated;
• The Collegiate Board evaluates the final regulatory proposals on the cultivation of Cannabis for medicinal or scientific purposes and the registration and monitoring of medicines;
• Creation of Resolution of the Collegiate Board (RDC) 327/2019, which establishes requirements for the commercialization, prescription, dispensing, monitoring, and inspection of Cannabis products for medicinal purposes. 

Another important highlight was an exclusive interview on this portal with the former director of Anvisa, Renato Alencar Porto, who at the time announced that the cultivation of cannabis for medicinal and research purposes would be allowed that year, very important and exclusive information obtained by Sechat. 

Today, in 2022, the Brazilian reality is very different, currently, there are already 11 cannabis-based products authorized by the agency for commercialization and consumption. 

Among them, five are based on Cannabis sativa extracts and six on cannabidiol. They are:

– Canabidiol Prati-Donaduzzi (20 mg/mL; 50 mg/mL and 200 mg/mL); 

– Canabidiol NuNature (17.18 mg/mL); 

– Canabidiol NuNature (34.36 mg/mL); 

– Canabidiol Farmanguinhos (200 mg/mL); 

– Canabidiol Verdemed (50 mg/mL); 

– Cannabis sativa extract Promediol (200 mg/mL); 

– Cannabis sativa extract Zion Medpharma (200 mg/mL);  

– Canabidiol Verdemed (23.75 mg/mL); 

– Cannabis sativa extract Alafiamed (200 mg/mL); 

– Cannabis sativa extract Greencare (79.14 mg/mL); and 

– Cannabis sativa extract Ease Labs (79.14 mg/mL). 7

On this day, as we celebrate the anniversary of the National Health Surveillance Agency, we hope to also celebrate the continued growth and prominence of research development and access to cannabis-based medicines in Brazil, always with the contribution and guarantee of quality that respect the standards of the regulatory health agency.