The latest episode of Deusa Cast, a podcast from Portal Sechat, brought together industry experts to discuss the advances and challenges of medicinal cannabis in Brazil. Among the topics discussed, the five-year deadline that companies have, after a product is authorized, to present clinical efficacy studies stood out, a deadline that may undergo changes in the revision of RDC-327.

Participating in the conversation were: Larissa Meneghel, a lawyer specializing in health law and former Anvisa civil servant; Paula Scanapieco, commercial manager at Mile Express; and Juliana Sousa, lawyer in the areas of customs and criminal law.

“It's not about flexibility, it's about feasibility,” says expert

Responding to the question about how this deadline works and what changes may occur, Larissa Meneghel highlighted that the creation of RDC-327 in 2019 was a direct response to social demand for access to medicinal cannabis products, in a context where registration as a medicine was practically unfeasible due to barriers to importing the plant and conducting studies in Brazil.

She explained that the current authorization is temporary, valid for five years, and serves as an incentive for companies to complete clinical studies and register the product as a definitive medicine.

Possibility of Renewal for Companies in Research Phase

According to Larissa, the proposal under discussion in the public consultation of RDC-327 provides that companies already conducting clinical studies, but unable to complete them within the initial deadline, may request an extension for another five years. This, according to her, is not about relaxing the rule, but about ensuring that complex research, which goes through several phases and requires high investment, reaches completion.

Learn More - RDC 327 Review: Impact on the Brazilian Medicinal Cannabis Market in 2025
 

The lawyer also emphasized that cannabis clinical studies follow global quality standards, requiring certified centers, Anvisa oversight, and rigorous good clinical practices. “The investment is very high and requires impeccable documentation for the definitive medicine registration to be approved,” she pointed out.

Check out the full conversation on Deusa Cast

The episode also provides details on the regulatory landscape, legal barriers, and prospects for the medicinal cannabis market in the country. To fully understand the implications of the RDC-327 revision and listen to all the analyses from the team of experts, it's worth checking out the full interview on Deusa Cast, available on the Youtube channel.