2025 was a strategic year for Brazil’s Life Sciences sector. The Ministry of Health moved forward with the approval of dozens of Productive Development Partnerships (PDPs) and Development of Local Innovation Partnerships (PDIL) projects, while also issuing guidelines intended to steer these initiatives going forward. Brazil’s Clinical Research Act was regulated through Decree No. 12,651/2025, providing long-awaited operational contours to the new legal framework.
Anvisa (Brazilian FDA), in turn, signaled a stricter stance toward compounding pharmacies, particularly by restricting the importation of GLP-1 receptor agonist APIs (weight-loss injectables) by such establishments. The Agency also reinforced its commitment to reducing regulatory backlogs, as reflected in its tactical plan that allowed companies to withdraw a pending marketing authorization application that has not yet entered formal review and replace it with a new application for a different medicine. Finally, CMED played a central role in advancing a new framework for drug pricing.
Much of what occurred in 2025, however, should be read as a starting point for the regulatory and policy developments expected in 2026. Below we outline the key themes to watch in 2026 for the regulated Life Sciences market.
CMED is expected to progress with the ongoing public consultation aimed at drafting a rule on medicine pricing in sales to the Public Administration for the fulfillment of judicial orders. Contributions may be submitted until March 16, 2026.
The initiative follows technical analysis identifying material distortions associated with the judicialization of healthcare - particularly increased public expenditure and budgetary unpredictability. The proposal also seeks to align regulation with the Supreme Court decision (Theme 1234), under which, in lawsuits seeking the supply of medicines, judges must set the lowest sale value among: (i) the discounted price proposed in the CONITEC incorporation process; and (ii) the price already practiced by the relevant public entity in public procurement. Under no circumstances may the price exceed the Maximum Government Sale Price (PMVG).
ATMPs have historically lacked tailored and objective pricing parameters under CMED Rule #2/2004. This regulatory gap has contributed to prolonged review cycles and a higher propensity for disputes. CMED Rule #3/2025 expressly confirms that ATMPs remain outside the core categorization and pricing criteria applicable to new medicines. CMED has signaled an intention to advance the regulatory treatment of ATMPs in 2026.
One of the key innovations is the regulatory sandbox (Topic 1.6), aimed at establishing an experimental regulatory environment. The sandbox is intended to enable Anvisa to test emerging technologies and novel regulatory approaches that are not yet fully addressed under the existing framework. Notably, smart hospitals could be contemplated within regulatory sandbox arrangements, suggesting a wider scope that may include digital health, interoperability, and AI-enabled clinical decision support.
Other priority topics include updating technical requirements for the marketing approval of biological products (Topic 9.4) and updating clinical trials regulation for advanced therapy products (Topic 9.3) to harmonize with the new ethical governance structure. Furthermore, the review of expanded access programs regulation (RDC #38/2013) is expected to be important for therapies in rare diseases and oncology.
Anvisa is expected to revise Good Manufacture Practices for Compounding Pharmacies (Rule #67/2009). In 2026, the Agency is expected to reduce legal uncertainty by issuing more granular criteria, potentially tightening controls on sourcing and setting clearer limits to prevent individualized compounding from evolving into industrial-scale manufacturing.
On December 31, 2025, the Ministry of Health issued Informative Note #17/2025, establishing methodological criteria for calculating technology transfer costs in Productive Development Partnerships (PDPs). The Note states that technology transfer must be priced in a manner that preserves economic balance and requires transparency regarding value components.
The full implementation of the new clinical research framework will depend on complementary rules to be issued by the National Instance of Ethics in Research (INAEP). Key pending items include guidance on Post-Study Access Plans and requirements for the accreditation of Research Ethics Committees (CEPs).
In 2026, stakeholders should monitor ADI 7875, which challenges provisions of the Clinical Research Act, including the statutory five-year limit for post-trial access and provisions allocating liability for harm. A decision from Justice Cristiano Zanin on the preliminary injunction remains pending.
This section gives quick answers to the most common questions about this insight. What changed, why it matters, and the practical next steps. If your situation needs tailored advice, contact the RNA Law team.
Q1: What are the main changes expected for CMED in 2026?
A1: CMED is expected to finalize rules for pricing medicines supplied under court orders and establish a specific pricing framework for Advanced Therapy Medicinal Products (ATMPs).
Q2: What is Anvisa’s regulatory sandbox?
A2: It is an experimental environment designed to test emerging technologies and novel regulatory approaches, potentially including smart hospitals and digital health solutions.
Q3: How will the Ministry of Health impact technology transfers?
A3: Through Informative Note #17/2025, the Ministry established criteria to ensure transparency and economic balance in calculating costs for technology transfers in PDPs.
Q4: Why is the Clinical Research Act being challenged in the Supreme Court?
A4: ADI 7875 challenges the five-year limit for post-trial access and the allocation of liability for harm between sponsors and research institutions.
.png)
