Ian specialises in pharmaceutical regulatory affairs, mainly in the EU and the UK but also in Australia, New Zealand, Canada and certain African markets. His key areas of focus are clinical trials, market access, intellectual property issues, global regulatory alignment and pandemic preparedness. A modern languages graduate, he worked in the European travel industry before joining Scrip in 1985 as a reporter covering the French and Italian markets. He subsequently held posts including Deputy Editor of Scrip and Principal Analyst at Informa, before taking up his current position at the Pink Sheet. As well as writing news, features and analysis, Ian is part of the Ask the Analyst team that produces on-demand tailored reports for subscribers. His non-work interests include cycling, travel, paddleboarding and playing traditional Scottish music.
Latest from Ian Schofield
The 2025 social security financing bill includes measures to reduce spending on reimbursed drug costs, change the way that industry paybacks are calculated, and tackle medicine shortages.
The proposed new EU guidance will focus on the regulatory and methodological aspects of clinical trial design and marketing authorization for tRPs, according to a concept paper that has just been issued for public consultation.
Issues raised in the first six months of the new VPAG include potential adverse impacts on both older and newer innovative drugs, as well as uncertainties over the “exceptional circumstances” clause that allows requests for price increases or cuts in repayment rates.
As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.
France’s regulatory agency, which triggered the review, says it believes that the addition of suicidal ideation to the product information for finasteride and reports of cases of completed suicide “seriously alter” the product’s benefit-risk profile.
NHS England says it is proposing a “realistic but challenging uptake trajectory” that will make “this clinically and cost-effective drug” available to as many patients as possible without overwhelming health care providers.