Brazil

Brazil’s medicines regulator, ANVISA, has hired new staff to help halve the time it takes to register a new medicine in Brazil.

Regulatory reliance processes for drug registration and clinical trial application approvals in Brazil have not met their “full potential,” says Brazil’s medicines regulator.

A new decree in Brazil establishes a new ethics governance and operational structure in clinical research and seeks to better protect clinical trial participants.

Brazil’s government has implemented a three-pronged strategy to protect local industry, including medtech, from the worst effects of the 50% US tariff on Brazilian exports. But the option of counter-tariffs has not gone away.

MDA, the Malaysian medical devices regulator, told the 2025 APACMed conference about its efforts on regulatory convergence, harmonization and reliance, which are top of its priority list for aiding medtech regulatory workflows and granting faster access to innovative devices.

Kashiv has landed another deal for its omalizumab biosimilar, this time with Brazil-based Cristália in Latin America.

Brazil is planning to update its National Clinical Research Action Plan to make the country a more competitive location to conduct R&D.

Brazil is planning to update its National Clinical Research Action Plan to make the country a more competitive location to conduct R&D.

Two of Latin America’s biggest regulators have signed a memorandum of understanding to deepen cooperation and improve access to medicines.

Hopes that last-minute negotiations might exempt Brazil’s $300m medtech exports from the latest round of US tariffs have been dashed, leaving the industry braced for further market instability that countermeasures could trigger.

Roche’s filing for Elevidys in the EU followed applications in Middle Eastern countries because those markets accept applications based on approval by the US Food and Drugs Administration.

There is a place for using external reference pricing to set prices of advanced therapies, but any such mechanism must take into account the specificities of the Brazilian market and health system.