MHRA
Three investigational medicines receive Innovation Passports
MHRA announced Innovation Passports for investigational treatments with the potential to address unmet needs in lung cancer, Huntington’s disease and Alzheimer’s disease through the Innovative Licensing and Access Pathway.
Read the official sourceMHRA
International Recognition Procedure guidance updated
MHRA updated its guidance on using the International Recognition Procedure for medicines licensing applications.
Read the official sourceMHRA
Exceptional use authorisations list updated
MHRA updated its list of manufacturers and medical devices granted exemptions, including exemptions that expired or were cancelled.
Read the official sourceMHRA
UK data and market exclusivity information updated
MHRA updated information covering UK reference medicinal products authorised from 2014 to 2021 and the associated expiry dates for data protection and marketing exclusivity.
Read the official sourceWhy this matters
These updates give regulatory teams current reference points for UK development support, reliance based licensing, exceptional device access and exclusivity planning. Innovation Passports signal entry into a coordinated pathway, while the updated guidance and lists support accurate submission and lifecycle work.
Scott Morvay
Founder, Gulfstream Intelligence
This brief provides general regulatory news and educational information. It is not legal or regulatory advice.