MHRA issues its first medicinal product approval through the International Recognition Procedure

The UK medicines regulator, the MHRA, has set out a pro-innovation agenda, with a particular focus on faster and more efficient approval processes. In 2023, details of the International Recognition Procedure (IRP) for fast-track approval of medicines were published, proposed to go live at the start of 2024. 

Now the MHRA has started granting marketing authorisations through the IRP. The  first was issued in February in just 30 days. This was for a new formulation of monoclonal antibody XGEVA (denosumab), a treatment to prevent serious bone-related complications caused by bone metastasis and for giant cell tumour of bone.

The IRP was launched on schedule in January 2024, replacing the existing EC Decision Reliance Procedure and incorporating the Mutual Recognition/Decentralised Reliance Procedure. It is open to applicants that have already received an authorisation for the same medicinal product from one of the MHRA’s specified Reference Regulators in Australia, Canada, the European Union, Japan, Switzerland, Singapore or the United States.

The IRP can be used for the following types of marketing authorisation applications:

  • chemical and biological new active substances and known active substances;
  • generic applications;
  • hybrid applications;
  • biosimilar applications; and
  • new fixed combination product applications.

The IRP can also be used for post-marketing authorisation procedures including line extensions, variations and renewals. It does not cover the herbal and homeopathic product categories.

The “same medicinal product” requirement means that the product has the same qualitative and quantitative composition (including active substance(s) and excipient(s)) and the same pharmaceutical form, and the applicant is an affiliate or licensee of the holder of the reference marketing authorisation.

An initial eligibility screen will determine whether the application is eligible for IRP, and if so, whether it should be allocated to stream A or B. The Recognition A stream has more stringent requirements, such as a recent approval and evidence of Good Manufacturing Process manufacture. This offers a 60-day timetable from validation. Recognition B is for more complex applications and can take 110 days, with a clock stop to address any issues. If unresolved issues remain after these timescales, the application can move from A to B, or revert to the national 210-day timetable.

Detailed information on the requirements and procedure is available here.

The aim of the IRP route is to save time and reduce duplication of effort for both applicants and regulators. The MHRA still retains discretion as to whether to accept applications submitted under the IRP and is explicit that it may reject applications if it considers the supporting evidence to be insufficiently robust.

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