Policy

Portugal has made permanent a pilot aimed at cutting review timelines for certain clinical trial applications.

International reliance mechanisms for approving drugs have an important place, but the UK regulator should increase focus on becoming a first approver of medicines, according to the British pharmaceutical industry.

South Korea has laid out comprehensive drug pricing reforms that aim to enhance patient access to treatment, accelerate innovation and stabilize essential drug supplies, but the industry is concerned it could lead to weaker R&D and manufacturing and increased dependency on high-priced imports.

Pragmatic solutions are called for to ensure that German medical device manufacturing and innovation remain competitive in global terms, federal health minister Nina Warken told a hearing of medtech industry leaders.

Under the newly-announced UK-US trade deal, the UK will increase the thresholds used to evaluate the cost-effectiveness of new medicines, which should allow higher prices for innovative therapies.

The pharmaceutical industry has been pushing back on a deeply unpopular rebate on products deemed to be “free combination” medicines in Germany.

India is advancing regulatory rationalization efforts, refining procedures and pathways. Guidelines for biosimilars are expected to align with international standards, while early steps towards PIC/S compliance have been initiated.

Under the Inflation Reduction Act, CMS negotiated lower Medicare Part D prices for 15 drugs with 2027 costs 38%-85% lower than 2024 list prices, but analyses of net prices paid last year show smaller discounts.

France is set to pilot a new fast-track process that could more than halve the timeline for authorizing certain clinical trial applications.

With UK chancellor Rachel Reeves set to deliver the country’s budget on Wednesday, Medicines UK has set out five “focus areas” where the off-patent industry believes that action is needed.

With UK chancellor Rachel Reeves set to deliver the country’s budget on Wednesday, Medicines UK has set out five “focus areas” where the off-patent industry believes that action is needed.

Argentina’s medicines regulator, ANMAT, is updating the national pharmacopeia with new guidelines on advanced therapies.