The Evolution Of Drug Regulation In Post-Brexit Britain
Regulatory reliance is playing an increasingly important role in gaining marketing authorization in the UK following Brexit. Meanwhile, the country’s unique Innovative Licensing and Access Pathway is attracting growing levels of interest, not just from companies but from regulators and health technology appraisal bodies across the world.
You may also be interested in...
US FDA Eyes Project Orbis-Type Approach For Cell And Gene Therapies
A process in which the FDA coordinates reviews with other regulators would allow for better leveraging of global patient populations with ultra-rare diseases and attract more commercial interest in a given disease area, CBER’s Peter Marks tells the Biopharma Congress. The biologics center also looks to apply the philosophy underlying the Real-Time Oncology Review program.
UK Prepares ‘First-In-Kind’ Regulatory Framework For Point Of Care Manufacturing
The UK government is developing a new regulatory framework that is intended to make it easier to manufacture medicines at the point of care, including advanced therapies.
UK Industry Urges Government To Drop Statutory Pricing Scheme Rate Hike
The ABPI, which represents the R&D-based pharmaceutical industry in the UK, says the proposed increase in the statutory scheme rebate sends "the worst possible signal" to global investors and boardrooms.