UK Windsor Framework Enters Into Force
Recent UK regulatory developments of potential interest to international life sciences companies include: reforms aimed at speeding up medicines approvals and market access, global firsts with respect to certain orphan drug and cancer diagnostic approvals, and updates on unified packaging and labeling across the UK. Article authored by Dr. Chris Boyle and Dr. Kwabena Tenkorang.
“Refreshed” UK-wide Innovative Licensing and Access Pathway (ILAP) Applications Now Open
Commercial and pre-commercial developers of potentially transformative medicines or drug-device combination products can now utilize a unique accelerated regulatory pathway in the UK. Article authored by Marie Manley and Victoria Kerr. (more…)
European Court of Justice Judgment Relating to Orphan Market Exclusivity
In a recent judgment, the Court of Justice of the European Union (CJEU) has shed light on the scope of the ‘clinical superiority’ criteria providing for a derogation to orphan market exclusivity which is key to protect the orphan molecule from competition for the period of market exclusivity (10 or 12 years as the case may be). Marie Manley, Chris Boyle, and Alix Vermulst examine the impact of this judgment on pharmaceutical companies.
Medicines and Healthcare Products Regulatory Agency: The Road to Medical Device Reform
The Medicines and Healthcare Products Regulatory Agency (MHRA) has recently published three policy developments as part of its overhaul of medical device regulation in the UK. The AI Airlock, announcement of international recognition procedure for medical devices, and consultation on technical specifications for the In Vitro Diagnostics Regulation (IVDR) signal the MHRA’s continued focus on reform and international alignment in this area. Industry stakeholders should take note and engage with the regulator where possible to have their voices heard as part of the process.
