New ANVISA resolution updates criteria for simplified registration and brings greater clarity to the regulatory process

With official publication in April and expected to come into force in October 2024, RDC No. 954/2024 brings an important update to the drug registration process with ANVISA. The new rule repeals RDC No. 199/2006 and redefines the criteria for classification, the required documentation and the technical procedures applicable to the simplified registration.

QR Group, a reference consultancy in health product regulation, analyzes the main impacts of the new resolution and guides pharmaceutical companies on how to ensure compliance efficiently and safely.

What changes with RDC 954/2024?

The new rule represents an effort by ANVISA to modernize and standardize the simplified registration of medicines, with a focus on technical clarity, predictability and agility. Among the main changes are:

• Clearer criteria for classification in the simplified procedure;

• Reorganization of the documentary requirements for submission;

• Adequacy to the health risk assessment model;

• Harmonization with international practices, including references such as FDA and EMA.

These updates were developed based on contributions received in public consultation and reflect an important advance in the regulation of medicines in Brazil.

Impacts for companies that register medicines

RDC 954/2024 directly impacts companies that already use — or wish to use — the simplified registration for generic, similar, or streamlined drugs. Among the main points of attention are:

• Need to review and readjust the dossiers in progress;

• Update of internal electronic petitioning processes;

• Identification of products that may migrate to the new regulatory model;

• Training of technical and regulatory teams on the new criteria.

The transition to the new model requires planning, technical mastery and alignment with the current legal frameworks.

How QR Group can support your company

With solid performance in the regulatory sector and deep technical knowledge of ANVISA standards, QR Group offers:

• Portfolio-Customized Regulatory Impact Analysis;

• Review of technical dossiers based on RDC 954/2024;

• Strategies for secure migration of ongoing processes;

• Full support in petitioning, submission and regulatory follow-up.

Our multidisciplinary team works to transform regulatory updates into competitive advantages for our clients.

Talk to QR Group

Does your company need to adapt to the new requirements of RDC 954/2024?
QR Group offers complete technical support to ensure safety and efficiency in the registration of medicines with ANVISA.

Source: QR Group