From ECDRP to IRP: What Pharma Companies Need to Know About MHRA's New Procedure

The recent shift in the UK's regulatory landscape, marked by the adoption of the International Recognition Procedure (IRP) by the Medicines and Healthcare products Regulatory Agency (MHRA), is a significant milestone for the pharmaceutical industry. This new procedure, which replaced the European Commission Decision Reliance Procedure (ECDRP) as of January 1, 2024, promises a streamlined path for drug approval, enhancing the growth of science, market access, and patient care.

UPDATES ON: MHRA International Recognition Procedure

Our Senior Vice President of Regulatory Affairs & Technology, Mallikaarjunan R, provided key insights about IRP in an article titled “Insights on the UK's MHRA International Recognition Procedure”, published in Pharmacy Times recently.

In this blog, we met Malli to understand more about the strategies required for the implementation of IRP and its significance.

Mallikaarjunan R

Senior Vice President of Regulatory Affairs & Technology

What is the significance of the MHRA’s International Recognition Procedure?

MHRA’s International Recognition Procedure (IRP) is replacing the European Commission Decision Reliance Procedure (ECDRP) as of January 1, 2024. It benefits healthcare professionals, patients, and the pharmaceutical sector by reducing time, cost, and labor.

The significance of the new IRP procedure has a Faster timeline procedure as compared to the National/Centralized procedure. It may be concluded in just 60 to 110 days. The IRP integrates and simplifies both the Mutual Recognition/Decentralised Reliance Procedure (MRDCRP) and the ECDRP under one streamlined process.

Furthermore, MHRA’s IRP procedure is a well-defined procedure type that could aid us in identifying which path is suitable for our product. This makes it easier to file the new drug application for regulatory compliance associates.

In your article, you mention potential benefits of the procedure. Please elaborate on how it might streamline drug approval processes and improve patient access to medications?

The potential benefits of the IRP are cost-effective, Integrated approval, Blended approach, Single stroke of application, Timesaving.

The IRP procedure will enable the MHRA to consider the expertise and decision-making of trusted regulatory partners, for the benefit of UK patients. Also, MHRA will conduct targeted assessments of applications if required. It will also have the power to refuse applications if the evidence provided is not sufficient.

The applications approved by reference regulators are processed under the IRP, allowing for the earliest approval of new drugs into the UK market. This will make the drugs available for healthcare professionals and patients faster. This procedure will ensure the safety and efficacy of the drugs in the UK market by comparing the data with the Reference Regulator’s (RR) application.

What challenges do you foresee for pharmaceutical companies in adapting to the MHRA's new recognition procedure, and how can they prepare for these changes?

The major challenge starts with the appropriate interpretation of the MHRA IRP guidance on whether the targeted product falls under the IRP procedure. To overcome this and ensure the correct requirements, an applicant can request pre-submission meetings for further proceedings on the application and any further clarifications or testing required.

The challenge is in how to file the application through IRP, CROs like Navitas can support end-to-end product registration in MHRA through IRP.

What role do you see digital health technologies playing in the implementation and success of the MHRA's International Recognition Procedure?

Digital health technologies play a vital role in monitoring and assessing patient conditions of respective therapeutic category drugs. Artificial intelligence is already in existence for the application of drug approval processing aids. MHRA has the eligibility checker for new drug applications to determine whether the drug is eligible for the IRP or not.

How does Navitas Life Sciences' expertise and services uniquely position the company to support clients with the MHRA’s new regulatory framework?

Navitas Life Sciences offers expert regulatory compliance services for applicants seeking guidance on product eligibility and UK-EU establishment support. Our experienced Subject Matter Experts (SMEs) and Strategists help define procedure frameworks and submission timelines, ensuring right-first-time submissions. Additionally, they assist with Health Authority (HA) negotiations to secure quick approval.

Navitas Life Sciences: Empowering Life Sciences Companies to Ensure Regulatory Compliance

Navitas Life Sciences, an experienced partner for your end to end reg needs aids in achieving and maintaining compliance in a rapidly evolving regulatory environment. Our expertise and tailored regulatory compliance services enable companies to:

The IRP represents a significant advancement in the UK's regulatory environment, providing a streamlined, efficient pathway for drug approval. As the industry continues to evolve, Navitas Life Sciences remains committed to supporting clients in ensuring regulatory compliance, ensuring timely access to innovative treatments for patients.

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