Policy

The Irish government has struck new in-principle agreements with the innovator and off-patent pharmaceutical sectors to help make the health care system more sustainable.

Changing self-GRAS regulation, providing NDIN safety and identity guidance and modernizing supplement industry regulatory framework are on FDA’s “2026 priority deliverables,” but not requirement for public listing of all supplements available.

The US pharmaceutical market is critical for European pharma companies, but new policies introduced by the Trump administration are creating an increasingly complex and uncertain environment for them.

FDA Human Foods Program’s list notes Kennedy’s GRAS focus as first item in “Food Chemical Safety” category, saying the agency in 2026 “will publish a proposed regulation to require the submission to FDA of GRAS notices for all substances claimed to be GRAS.”

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

Consumer health product industry regulatory experts discuss two central questions: What trends, challenges, or opportunities do you expect will define the industry in 2026? Did developments you anticipated materialize?

Industry trade group executives discuss two central questions: What trends, challenges, or opportunities do you expect will define the industry in 2026? Did developments you anticipated materialize?

New compliance measures for big pharma under the amended EU sustainability reporting and due diligence directives could lead to new contractual requirements for smaller partners.

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

CRN’s support, a pivot from qualified backing for the previous bill, came after the senator added language to relieve firms of some responsibility around providing all claims for their products to FDA to include public-facing list.

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.

“Our sense is that companies are currently focused on timing, scope and execution. For example, knowing when a final order might issue … We also imagine that formulators are scrutinizing the proposed list of permitted combinations, the 6% cap, and the permitted dosage forms,” say ArentFox Schiff att