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On Deusa Cast, lawyer Larissa Meneghel details how the five-year deadline set forth in RDC-327 for clinical cannabis research works and comments on the renewal proposal under review by Anvisa
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.
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