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EU Reforms Include ‘Prudent-Use’ Targets For Cuts To Antibiotic Consumption

 
• By Ian Schofield

The European Commission says at least 65% of all human consumption of antibiotics should be of products that come under the World Health Organization’s AWaRe (Access, Watch, Reserve) classification, which have a lower risk of resistance.

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The EU proposals for tackling AMR are the latest in a long line • Source: Shutterstock

Repeated attempts to tackle antimicrobial resistance (AMR) have failed to make much of an impact, but hope springs eternal and the European Commission is throwing its weight behind a combination of incentives and cuts in antibiotic consumption that it hopes will help tackle what it calls “one of the top three health threats” facing the EU.

As part of the legislative reform package published on 26 April, the commission is putting forward a key pull incentive for the development of new antimicrobials: the use of transferable...

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More from Europe

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

UK And US Regulators In Sync On RWD External Control Arms

 
• By Vibha Sharma

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.

More from Geography

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

Japan Price Cuts For Epkinly and Lunsumio Following CEA

 
• By Lisa Takagi

Japan is cutting more drug reimbursement prices following cost effectiveness analysis and is applying the methodology to a new group of products including Wegovy and Leqembi.