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
With approval applications for new active substances expected to rise by 25% by 2026, the UK regulator says it wants to focus its national assessment procedure on new innovative therapies. It will also review progress with the new International Recognition Procedure.
As talks continue on the EU pharmaceutical legislative reform proposals, drug firms may have to wait some time before they find out what the future periods of regulatory data protection and orphan market exclusivity will be.
Some stakeholders say that the entry criteria for the licensing and access pathway have been too broad, leading to an overburdening of the scheme.
Transitional provisions have been put in place to ensure the smooth implementation of new trial rules and requirements in Switzerland.
Updated guidance issued by the EU regulator explains how to comply with the provisions of the amended Variations Regulation, which will apply to new submissions from January 2025 and is intended to make lifecycle management “more efficient and future-proof.”
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.