International Recognition Procedure

From 1st January 2024, the MHRA will be introducing new International Recognition Procedures (IRP) for marketing authorisations in the UK for both new and generic medicines.

These recognition procedures will absorb the existing EU recognition procedures; the EC Decision Reliance Procedure (ECDRP) and the Mutual Recognition/Decentralised Reliance Procedure (MRDCRP), as well as introduce new recognition procedures for medicines authorised by the MHRA’s specified Reference Regulators (RR).

The Reference Regulators that are accepted by the MHRA are as follows:

Country or Jurisdiction                                       Regulatory Authority
Australia Therapeutic Goods Administration (TGA)
Canada Health Canada
Switzerland SwissMedic
Singapore Health Science Authority Singapore (HSA)
Japan Pharmaceuticals and Medical Devices Agency (PMDA)
United States Food and Drug Administration (FDA)
European Union European Medicines Agency (EMA) and Member State Competent Authorities (This includes approvals through the centralised, MRP/DCP and individual member state national routes)

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.

International Recognition Procedure – GOV.UK
Ben Smith