What is the International Recognition Procedure (IRP)?

The UK Medicines and Healthcare products Regulatory affairs Agency (MHRA)’s International Recognition Procedure (IRP) is a mechanism through which the MHRA facilitates patient access to life-saving treatment options. The IRP enables the UK MHRA to consider the expertise of reference regulators across the globe in order to authorize medicines within the UK. Being the “sovereign regulator”, the MHRA holds the authority to accept or reject any applications submitted under the IRP route.

Who are the Reference Regulators?

Under the IRP, the MHRA concede assessments conducted by reference regulators that demonstrate robust regulatory standards and processes. These reference regulators include:

• European Medicines Agency (EMA)
• United States Food and Drug Administration (FDA)
• Health Canada
• Therapeutic Goods Administration (TGA) Australia
• Japanese Pharmaceuticals and Medical Devices Agency (PMDA)

What are the Timelines and Fees for IRP?

The UK MHRA International Recognition Procedure (IRP) offers two recognition timetables for initial Marketing Authorization Applications (MAAs):

a- Recognition A

b- Recognition B

Recognition A follows a 60-day timetable without clock stops, whereas Recognition B allows one clock stop at day 70, with a total of 110 days (about 3 and a half months). If Major Objections persist by day 110 in Recognition B, advice on approvability is sought from the Commission on Human Medicines (CHM), potentially extending the timeline. While fees associated with the IRP may vary based on the type of application and regulatory pathway, the MHRA aims to ensure transparency, accessibility and that cost considerations do not impede access to international markets. Applicants can find out more about the fees MHRA charges in the guidance MHRA fees and utilize the Fees Calculator to determine the fee for your submission

What is the IRP Application process?

Manufacturers seeking to leverage the International Recognition Procedure should follow a straightforward application process outlined by the MHRA:

• The Applicant/Marketing Authorization Holder (MAH) must be established in the UK or EU/EEA, preferably within the same legal group as the Reference Regulator (RR) for ease of compliance with legal obligations. However, third-party applications are accepted with written assurance of meeting obligations.
• An eligibility form, completed six weeks before the planned submission date, determines Recognition A or B suitability. Submit the form along with the MAA application if eligible. Triage requirements are emailed to Recognition@mhra.gov.uk if needed.
• For New Active Substances, notify MHRA of intent to submit at least six weeks prior. Include the eligibility form in module 1.2 of the eCTD.
• IRP applications are submitted through the Human Medicines Portal as electronic Common Technical Documents. Ensure documents are in English or include certified translations. MHRA does not solicit RR documents.
• A pre-submission meeting isn't mandatory but can be requested. Indicate Recognition Route A or B during submission. Post-authorization submissions should include RR approval documentation and iterations of assessment reports.
• Cover letters for validation must include specific details such as Reference Regulator, type of approval, proposed conditions, differences in indications, and summary of regulatory history.