QR Group analyzes how the strategy strengthens regulatory trust and facilitates the registration of health products in Brazil

In 2024, ANVISA released the list of priority foreign regulatory authorities to strengthen the process of regulatory trust in Brazil. The measure is part of the agency’s regulatory agenda and aims to streamline analysis and decisions through the recognition of evaluations carried out by health agencies of high international standard.

QR Group, a consulting firm specializing in health product regulation, explains the impacts of this decision for companies that wish to register or import products with prior approval abroad, and how the strategy can reduce regulatory deadlines and costs.

What are priority authorities and what is the impact of this definition?

The priority foreign authorities are international regulatory agencies considered a reference by ANVISA for adopting technical standards equivalent to or superior to those of Brazil. By formally recognizing them, ANVISA begins to accept or consider their decisions to support regulatory processes in Brazil.

Examples of recognized authorities include:

• FDA (United States)

• EMA (European Union)

• Health Canada (Canada)

• PMDA (Japan)

• TGA (Australia)

This regulatory trust strategy has the following main objectives:

• Accelerate the registration of health products in Brazil;

• Reduce technical redundancies in the evaluation process;

• Increase regulatory predictability and transparency;

• Strengthen alignment with international practices.

How this measure benefits companies operating in Brazil

The definition of priority authorities brings significant advantages to companies that operate globally and seek to expand into the Brazilian market:

• Products already approved by reliable agencies may have faster analysis by ANVISA;

• Reduction of documentary requirements, as long as the data is harmonized with international standards;

• Saving time and resources in the registration process;

• Increased regulatory predictability, especially in complex categories such as biologics and medical devices.

Companies that structure their dossiers based on international guidelines gain a competitive advantage in this new scenario.

How QR Group helps your company take advantage of this opportunity

QR Group acts strategically in the regularization of international products with ANVISA, with a focus on technical trust and regulatory agility. Our services include:

• Adequacy of international dossiers to the ANVISA standard, with comparative analysis;

• Registration strategies based on recognized priority authorities;

• Technical dialogue with the agency, presenting international decisions as a regulatory subsidy;

• Full support in the petitioning and submission of clinical and technical data.

With experience in multinational processes and performance in line with the best global practices, QR Group guarantees security and speed in accessing the Brazilian market.

Talk to QR Group

Does your company want to register products approved in other countries in Brazil?
QR Group can accelerate your process based on regulatory trust and technical mastery.

Fonte: QR Group