Understand the Impact of RDC No. 948/2024 – Updates to Sanitary Requirements for the Regulation of Human Medicines

The Impact of RDC No. 948/2024 on the Regulation of Human Medicines

The Collegiate Board Resolution (RDC) No. 948, published in 2024 by the Brazilian Health Regulatory Agency (Anvisa), introduced significant changes to the sanitary regulation process for human medicines in Brazil. This new regulatory framework sets requirements for both the registration and notification of medicines, with implications that also extend to the post-registration phase. This article provides a critical analysis of the key innovations, advances, and points of concern introduced by this re...

1. Scope and Impacts of RDC No. 948/2024

RDC No. 948/2024 defines “sanitary regulation” as the authorization for manufacturing, importing, distributing, marketing, or dispensing medicines, whether through notification or registration, including potential post-registration changes. Any procedure involving changes to the product after registration must comply with the criteria established by the new resolution.

2. Regulatory Consolidation and Harmonization

One of the key achievements of RDC No. 948 is the consolidation of essential regulatory requirements for medicine registration. The regulation streamlines administrative documents, harmonizes definitions, and creates a unified framework for various categories of medicines.

- Previous RDCs related to administrative documentation have been revoked.

- A minimum mandatory documentation set is now required, even for medicines under older or incomplete regulations.

- Quality, safety, and efficacy requirements now apply to all medicine categories.

3. New Regulatory Tools and Strategies

3.1 Prior Consultation with Anvisa

The regulation formalizes the possibility of prior consultation for all medicine categories through technical meetings, study protocol reviews, or official service channels.

3.2 Rolling Submission

Documentation may be submitted over time, with assessments carried out as data becomes available.

3.3 Mandatory Technical Opinions

Anvisa’s technical opinions must now be published for all medicine categories, promoting greater transparency.

3.4 Approval with Pending Requirements and Terms of Commitment

It is now possible to obtain approval with pending requirements, provided they do not compromise initial evaluations. In more significant cases, Anvisa may require a formal term of commitment.

4. Inclusion of Real-World Evidence

A notable innovation is the inclusion of “real-world evidence” as part of the scientific documentation to demonstrate safety and efficacy. This broadens the range of valid data sources in the registration process.

5. Changes to Deadlines and Processes

5.1 Suspension of Processes

RDC allows registration processes to be suspended until Good Manufacturing Practices (GMP) assessments are complete, avoiding automatic rejections.

5.2 Tacit Approval

Tacit approval applies when legal deadlines (per RDC No. 743/2022) are not met, although implementation details remain unclear.

5.3 Price Notification Deadlines

The deadline to request price notification for priority medicines has been extended from 30 to 60 days.

6. Organization and Optimization of Reviews

Anvisa may organize review queues based on criteria such as chronology, medicine type, and petition characteristics (Art. 37). This system can expedite processing by grouping petitions with shared elements, such as medicines with the same active pharmaceutical ingredient (API). However, this may raise concerns about compliance with the principle of equal treatment, as earlier petitions might be reviewed alongside later ones, creating potential asymmetry.

Article 41 introduces the possibility of abbreviated, optimized, or even waived reviews based on sanitary risk. However, the absence of a clear "assessment management plan" is concerning, as it could lead to:

- Summary rejections without merit review, based solely on preliminary screenings (admissibility).

- Retroactive cancellation of approvals if conditions are breached—though a technical requirement notice must precede any cancellation.

7. Audit and Technical Evaluation

The regulation permits Anvisa to conduct compliance audits within regulatory processes, including petition groupings by company and in-person verification of obligations—especially for abbreviated or waived reviews.

8. Harmonization of Definitions and Documents

RDC 948 promotes the standardization of terms and concepts across RDCs and defines, for the first time, several key terms:

- Benefit-risk assessment

- Sanitary risk

- Rolling submission

- Tacit approval

- Compliance audit

It also standardizes the definition of “medicine” for the acceptance of international documents like the Certificate of Pharmaceutical Product (CPP), even when the product is classified differently in its country of origin.

9. Quality, Safety, and Efficacy Requirements

While specific quality standards are not yet unified across categories (e.g., synthetic vs. biological drugs), RDC 948 imposes minimum common requirements and demands complementary documentation in the absence of specific regulations.

For safety and efficacy, the regulation emphasizes:

- Updated clinical reports and technical-scientific data.

- Inclusion of both favorable and unfavorable clinical information.

- Presentation of the PSUR (Periodic Safety Update Report) for medicines already marketed abroad.

Conclusion

RDC No. 948/2024 represents a significant advancement in Brazil’s sanitary regulatory system. By unifying criteria, harmonizing documentation, and incorporating innovations such as real-world evidence and rolling submissions, the regulation modernizes and streamlines Anvisa’s processes.

Nonetheless, areas requiring attention remain—particularly regarding prioritization criteria, admissibility screenings, and the risk of summary rejections. Overall, the regulation expands opportunities and brings greater predictability to the registration process, provided it is applied with transparency and caution.