All International recognition procedure (IRP) articles
-
ContentsRegulatory Rapporteur June 2026 – Contents
The June issue of Regulatory Rapporteur focuses on lifecycle management.
-
EditorialLifecycle management: Enhancing regulatory agility
Navigating complex regulatory requirements across multiple regions and dealing with fragmented data are common challenges for keeping marketing authorisations and technical files compliant. This June issue of Regulatory Rapporteur looks at how AI and advanced digital technologies can help by integrating data and generating predictive insights, enabling more proactive lifecycle management and time for innovation.
-
JournalNavigating divergence: Practical lessons from the UK lifecycle management of licences
Four case studies demonstrate how marketing authorisation holders can optimise UK lifecycle strategy through the strategic use of national routes, the International Recognition Procedure and parallel submissions, despite increasing EU-UK regulatory divergence.
-
Industry newsMHRA’s IRP pathway now open for new medicines approvals
Medicines manufacturers can now submit marketing authorisation applications via the MHRA’s International Recognition Procedure.
-
Industry newsMHRA eligibility checker launched for IRP framework
The MHRA has launched an online eligibility checker tool for applications submitted via its International Recognition Procedure (IRP).
-
Industry newsMHRA publishes ‘recognition route’ revised guidance
The MHRA has issued guidance on its International Recognition Procedure, which will replace the EC Decision Reliance Procedure from January 2024.