Brazil

The Brazilian government wants to boost the country’s capabilities to develop radical innovation that leads to new therapies for the national health system.

Two major EU trade agreements are on hold, with ramifications for the pharmaceutical market.

Brazilian authorities say that some pharmaceutical companies exploit court cases brought by patients to secure drug access to achieve higher prices.

Brazil’s new drug pricing rules, which come into force in April, are intended to better recognize incremental innovation and give more predictability to the pricing of biosimilars.

Anvisa, the Brazilian medicines regulator, has published a new Q&A document relating to clinical research requirements. Meanwhile, the regulator’s new innovation committee, set up to monitor and evaluate innovative products, has set out its key priority areas.

Licensing agreement expands Polpharma’s footprint in Latin America while supporting Libbs’ strategy to grow access to advanced biologics in 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.