Updates to RDC No. 945/2024 on Clinical Research: Do You Know All Its Impacts?

New Directions for Clinical Research in Brazil: The Impacts of Anvisa’s New RDC

Anvisa’s Collegiate Board Resolution (RDC) No. 945/2024, published in November 2024, marks a significant milestone in the regulation of clinical research in Brazil. Promising greater predictability, speed, and legal certainty, the new regulation replaces RDC No. 09/2015 and RDC No. 449/2020, introducing key changes for both multinational and national studies. Below, we explore the main points discussed during a recent Inovatie-hosted webinar, where industry experts analyzed the practical implications of the new legislation.

What’s New: Highlights of the Regulation

One of the most impactful updates is the establishment of defined deadlines. All interventional studies involving medicines must now be reviewed by Anvisa within 90 business days. If no decision is issued within that timeframe, tacit approval is granted, and the study may proceed. This change particularly benefits national studies, which previously faced long delays and high levels of uncertainty.

In addition, responses to Anvisa’s requests can now be submitted even after the 90-day period without halting the study. This brings Brazil closer to countries with more modern regulatory frameworks and fosters international integration.

Investigator-Initiated Studies: New Structure and Responsibilities

The RDC introduces a new category: sponsor-investigator studies. In this model, the researcher acts as the study sponsor but must do so through a legal entity — individuals can no longer sponsor studies on their own. This shifts responsibility to institutions such as hospitals or clinics.

A notable change is the mandatory hiring of a Contract Research Organization (CRO) to conduct monitoring, auditing, and quality assurance. Researchers can no longer perform these functions themselves, which increases the cost and complexity of study planning.

The RDC also defines rules for medication donations. If a pharmaceutical company donates medication and intends to use the primary study data, it is considered a sponsor and assumes all associated responsibilities. If not, the company may act solely as a donor — provided it does not access or use the generated data. If the donated drug is unregistered in Brazil, the manufacturer — even if based abroad — is automatically designated as the sponsor, regardless of its intention to apply for market registration. This implies shared responsibility with the investigator.

Data Storage and Other Requirements

Clinical trial data must now be stored for five years following the final marketing authorization request related to the study (e.g., for initial registration, a new indication, or post-marketing purposes). This is a significant reduction from the previous 20-year requirement and relieves some of the financial burden on research centers. If a sponsor requires longer data retention, they must adequately compensate the center.

The Role of Reliance

The new RDC strengthens the use of Reliance, allowing Anvisa to consider evaluations by internationally recognized agencies (e.g., FDA, EMA). This expedites the analysis of studies already approved abroad and adds predictability. When Reliance is used, Anvisa may communicate directly with the foreign agency and adopt similar conditions.

Drug Importation: Streamlined and Strategic

The resolution permits companies to import study medications before final study approval, as long as all required data and quantities have been submitted. This more proactive approach reduces logistical delays and supports faster study start-up times.

Naturally, there are risks — if the study is denied or canceled, imported drugs must be redirected — but this is now a strategic decision left to companies.

Post-Study Medication: Ongoing Challenges

While the RDC does not directly regulate post-study access to medications, Brazilian law requires a justified and documented plan when such access is intended. This shifts greater responsibility to sponsors and helps prevent misuse.

Conditions such as diabetes, hypertension, and rare diseases continue to raise questions about long-term treatment, but the mandatory planning requirement is a step forward.

National Studies: The Biggest Beneficiaries

Although the regulation brings improvements across the board, national studies stand to gain the most. With standardized deadlines, more Brazilian studies are expected to emerge. However, the regulatory landscape still presents challenges — particularly related to pricing and intellectual property protection.

For instance, many national studies focused on incremental innovation are discouraged by the risk that their final product will be priced similarly to generics. Additionally, the lack of temporary protection against copycat products continues to deter investment.

Ethical Approval: A Shifting Landscape

With the enactment of Law 14.874/24, which governs research involving human subjects, ethical approval is also evolving. From now on, only Research Ethics Committees (CEPs) will issue approvals — the involvement of Conep is no longer required, even for multicenter studies. This change is expected to accelerate processes, though some uncertainty remains until the full regulation is implemented.

Looking Ahead

Although RDC 945/2024 has been in effect since December 2024, stakeholders are still adapting. Few cases of tacit approvals have been reported so far, but they are expected to become more frequent in the coming months.

A legitimate concern remains: Anvisa’s limited staffing may undermine efficiency. Experts are calling for the creation of a dedicated clinical research division within the agency to support its strategic importance.

Conclusion

RDC 945/2024 is a major advancement for clinical research in Brazil. It brings greater transparency, reduced bureaucracy, and more autonomy for both sponsors and investigators — ultimately positioning the country as a more attractive destination for scientific investment and innovation.

While challenges remain — particularly for investigator-initiated studies — the overall outlook is positive. With improvements expected in ethical and pricing regulations, Brazil is poised to consolidate its role as a strategic hub for scientific and technological development in healthcare.