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.
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Technical discussions on the EU pharmaceutical legislative reform are underway at the Council of the EU.
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.
Hemgenix has now secured reimbursement in several European markets, and while the path to reimbursement for the high-cost product has not always been easy, innovative access deals have helped to smooth the way.
A total of 748 key medicines are now affected by the four-month stock requirement, compared with 422 in 2021.
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.