This is effectively the Access Consortium territories (the group of medium size regulatory authorities aligned on regulatory principles) plus EU, Japan and USA (the founding members of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use).
The IRP will introduce 2 timetables for marketing authorisations submitted via this route:
- Recognition A: 60-day timetable (for recent applications of established active substances and “simpler” applications)
- Recognition B: 110-day timetable (for new active substances and “complex” applications)
These new regulatory routes aim to reduce the burden for both the MHRA and pharmaceutical companies in gaining new marketing authorisation applications in the UK by relying on the benefit-risk assessment of other regulatory agencies that align on principles of quality, safety and efficacy.
On the 14th September, the MHRA will be engaging with stakeholders and industry to outline their plans for the IRP, we will be attending and will be providing a detailed assessment of the IRP for our clients.
If you are interested in finding out more about these new and innovative procedures, please do not hesitate to get in touch with us.