Ian Schofield

Nov 13, 2024 | insights.citeline.com | Ian Schofield

UK Regulator Wants More Patient Input At Pre-Authorization Stage The MHRA is taking steps to embed “meaningful and impactful” patient involvement across its regulatory pathways. The MHRA wants more input from patients (Shutterstock)

Nov 12, 2024 | insights.citeline.com | Ian Schofield

New UK Rules On Supplementary Protection Certificates – Will You Be Affected? Companies are being encouraged to look at whether they will be impacted by new UK rules on supplementary protection certificates that come into effect from the beginning of next year. Brexit has required changes to the SPC rules in the UK (Shutterstock)

Nov 11, 2024 | insights.citeline.com | Ian Schofield

UK MHRA: ‘At Least Half’ Of Novel Drug Filings To Take National Assessment Route 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. The MHRA is expecting a rise in filings for innovative drugs (Shutterstock)

Nov 11, 2024 | insights.citeline.com | Ian Schofield

Uncertainty Remains Over The Future Of Regulatory Data Protection In The EU 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. • Source: JLBvdWOLF / Alamy Stock Photo (JLBvdWOLF / Alamy Stock Photo/Alamy Stock Photo)

Nov 6, 2024 | insights.citeline.com | Ian Schofield

‘New Era’ To Begin For UK’s ILAP In 2025, With Focus On ‘Transformative’ DrugsSome stakeholders say that the entry criteria for the licensing and access pathway have been too broad, leading to an overburdening of the scheme. The UK wants to encourage the development of "transformative" medicines (Shutterstock)