RDC 327 vote postponed at Anvisa; ABIQUIFI evaluates new deadline as "legitimate tool"

The National Health Surveillance Agency (Anvisa) postponed, this Wednesday (10), the vote on the proposal to revise Collegiate Board Resolution (RDC) No. 327/2019, which establishes the rules for the commercialization of Cannabis products in the country. The process, which will define important guidelines for the market, was halted after director Thiago Campos requested a review.

The decision postpones the Collegiate Board's deliberation for up to 30 consecutive days, projecting the conclusion of the topic to January 2026. The reporting director, Rômison Rodrigues Mota, had presented his favorable vote on the draft, detailing the proposed changes.

Process and Regulatory Framework

The Brazilian Association of Pharmaceutical Inputs Industry (ABIQUIFI) commented on the suspension, reinforcing its confidence in Anvisa's work and the legitimacy of the procedural tool used.

In an official statement, ABIQUIFI downplayed the impact of the postponement, seeing the review request as an opportunity for technical improvement.

"ABIQUIFI follows with confidence the revision process of RDC 327/2019, essential for the regulated development of medicinal cannabis products in Brazil. The review request made by Director Thiago Campos adds a few weeks to the schedule, but it is a legitimate tool and allows for a more in-depth analysis of relevant points for the regulator and the sector," the Association stated.

ABIQUIFI's stance signals the sector's interest in a solid and secure regulatory framework, reiterating its willingness to collaborate with the Agency. "We maintain the expectation that the review will be completed soon and reiterate our willingness to provide technical input and engage with Anvisa to strengthen a modern, safe regulatory framework that fulfills Anvisa's institutional purpose of promoting and protecting health."

Main Points of the Postponed Review

The draft presented by the reporting director Rômison Mota brought significant changes, notably regarding import restrictions.

The proposal suggests that the import of Cannabis products by individuals, via RDC No. 660/2022, will only be allowed if there is no equivalent product - in the same pharmaceutical form and concentration - already regularized and available in the national market.

Other highlights include:

Maintaining the THC limit above 0.2% only for use in palliative care for patients with irreversible conditions, contraindicated for individuals under 18 years old.

The requirement for quality control on national soil for all batches, including imported ones.

Exclusive sale in pharmacies with prescription retention and specific labeling, with a black band for products with high THC content.

The extended 12-month period for the import restriction to take effect aims to allow the national market to adapt and ensure patient supply before domestic purchasing priority becomes mandatory.

The review process of RDC 327, now in deliberative circuit, is expected to have its final opinion defined in the first half of January 2026.