United Kingdom

The UK generics market risks becoming unsustainable as prices hit “rock bottom,” the House of Lords has been warned in a letter signed by multiple stakeholder associations including Medicines UK.

Generics Bulletin reviews global regulatory developments across the world.

Joint Singapore-UK plan underlines direction of travel for MHRA after its embracing of international reliance (IR). Australia’s TGA has also broken new ground by recognizing the UKCA mark.

Roadmap version 1.0 is a living document, not a legislative instrument, that will be updated and tweaked for timings as necessary.

A slash in rebate rates is only a first step towards restoring the competitiveness of the UK’s pharmaceutical industry, according to the ABPI.

A new value set to be used by UK health technology appraisal body NICE is expected to impact the cost-effectiveness of some medicines and make room for higher drug prices.

Some companies in the UK undergoing a health technology appraisal by the HTA body, NICE, will see reimbursement recommendations for their products paused in the run up to the implementation of higher cost-effectiveness thresholds.

Digital technology and AI have pushed healthcare delivery to a transformational turning point, but market access, budget constraints and scaling adoption of innovation remain the eternal challenges for healthtech manufacturers.

The MHRA’s premarket statutory instrument for Great Britain should to be laid before UK parliament in Q2 and be in force by year end, in an ideal world. There are concerns that the new statutory instrument must align with imminent EU MDR changes.

Propranolol prices that were almost five times higher in November meant that the beta-blocker topped our table of UK price rises this month, as ciprofloxacin prices also continued to climb.

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.

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.