02/03/2026 | Pharmacy Guide

https://guiadafarmacia.com.br/nova-regra-da-anvisa-sobre-cannabis-impulsiona-pesquisas-na-unicamp/ 

The resolution that expands the possibilities of using cannabis-based therapies in Brazil, approved by the National Health Surveillance Agency (Anvisa) on January 28th, represents "a historic regulatory milestone" and benefits research already underway at Unicamp, according to professors from the Faculty of Pharmaceutical Sciences (FCF) at the university in Campinas (SP).

The resolution comes into effect on the date of publication and will have an initial validity of six months. According to doctors Priscila Gava Mazzola and Marcelo Polacow, both professors at FCF, the new rules benefit scientific research by allowing controlled cultivation, essential for standardizing the material used, as well as enabling the import of supplies with clearer rules and allowing the expansion of studies.

Among the products being developed at Unicamp are a hydrogel dressing, a skin adhesive, and an emulsion that can be administered orally. The goal is for the projects to expand the medicinal use of marijuana and offer more comfort to patients with different health conditions.

The change in the rule follows a request from the Superior Court of Justice (STJ). In November 2024, the court determined that Anvisa (Brazilian Health Regulatory Agency) should regulate the cultivation of the plant, provided it is exclusively for medicinal and pharmacological purposes.

The agency opened a Public Consultation on the topic in April 2025 and, in May of the same year, a document created by researchers from Unicamp and the Regional Pharmacy Council of São Paulo (CRF-SP) was sent to Anvisa with proposals for updating the regulations.

Products under development at Unicamp

Medicinal cannabis in adhesive form
A transdermal patch is under development so that the substance is absorbed through the skin into the bloodstream.

The goal is for the patch to be left on the skin for several days, without the patient needing to administer multiple doses, as happens with oil.

Marijuana dressing
Due to the anti-inflammatory properties of marijuana, research at the university is dedicated to creating a hydrogel film, a type of dressing with cannabinoids to help treat wounds.

The proposal is that it will have the same texture as a contact lens. In contact with water, it will hydrate and can be placed on the skin, acting both in healing and in treating inflammation and preventing infections.

Cannabis Oil with Improved Taste and Texture
Considering patients who may be bothered by the taste and texture of the already well-known cannabis oil, another research project seeks to develop an emulsion to be administered orally. The emulsion consists of a mixture of water and oil, to mask the odor and improve the taste.

What changes with the new rules on medicinal cannabis?
In the same session in which Anvisa expanded the possibilities for the use of cannabis-based therapies, the agency approved a resolution with restricted rules that allow companies and entities to cultivate medicinal cannabis in Brazil. The rule is aimed only at legal entities.

The measure allows the plant to be produced in the country exclusively to supply the manufacture of medicines and other products regulated by the agency. Production must be restricted to a THC content of up to 0.3%, a non-psychotropic substance, as established by the courts.

With the expansion of the use of medicinal cannabis:

• The agency authorizes the sale of the phytopharmaceutical cannabidiol in compounding pharmacies.
• The text allows the commercialization of medications for oral, sublingual, and dermatological use. Previously, only drugs for oral and inhaled use could be registered by the agency.
• Among the main points is also a change that broadens the profile of patients who can use cannabis-based medications with a THC (tetrahydrocannabinol) concentration above 0.2%.

Before the resolution, only patients in palliative care or with irreversible or terminal clinical conditions could use products above this level. Now, patients with serious debilitating diseases will also be able to use them.

Impacts on scientific research
According to Polacow and Mazzola, the regulation tends to expand patient access to cannabis-based products. This is because national production can reduce costs and facilitate the supply of different formulations in the country.

They emphasize that users who already depend on medications derived from the plant can benefit both from the possible drop in prices and from the emergence of more robust scientific evidence, capable of guiding future therapeutic indications.

For faculty, the new scenario may allow for:

• clinical trials with different cannabinoids;
• agronomic research to identify cultivars adapted to Brazil;
• pharmacokinetic and pharmacodynamic analyses;
• development of new products;
• production of Brazilian data to support future drug authorizations.

What else can be improved?

Faculty members believe there is room for future revisions, seeking to further reduce bureaucracy and revise technical limits such as the 0.3% THC ceiling, based on international evidence.

Source: G1