UK MHRA Guidance: Clinical Trials for Medicines: Apply for Authorisation in the UK & Early Access to Medicines Scheme (EAMS)

The UK regulatory environment now offers two important pathways for bringing innovative medicinal therapies to patients:

• The Early Access to Medicines Scheme (EAMS), which permits earlier availability of new medicines under conditions of unmet medical need; and

• The MHRA’s guidance “Clinical trials for medicines: apply for authorisation in the UK”, which provides the regulatory framework for initiating clinical trials of investigational medicinal products.

These 2 guidances not only address unmet medical needs but also streamline drug development and patient access.

1. The Early Access to Medicines Scheme (EAMS)

This scheme allows patients with life-threatening or seriously debilitating conditions to access medicines that do not yet have a marketing authorisation, where there is clear unmet medical need.

How it works:

• The manufacturer first obtains a Promising Innovative Medicine (PIM) designation;

• Then they apply for an EAMS Scientific Opinion from the MHRA, based on available data, to support access.

• The scientific opinion is voluntary, does not replace the normal marketing authorisation process, but enables prescribing by healthcare professionals during the interim period.

• The opinion lasts up to one year and can be renewed.

Why this matters:For companies and regulators alike, EAMS offers a strategic route to bring treatments to patients sooner without waiting for full licencing — especially valuable in areas with high unmet need. It also demonstrates the UK’s ambition to foster the life sciences sector and accelerate innovation.

Takeaway for industry:

• Identify candidate products early (unlicensed, with promising data + unmet need).

• Engage with MHRA and NHS stakeholders for PIM/EAMS designation.

• Prepare for parallel development: while the product is accessed under EAMS, full clinical development toward marketing authorisation continues.

2. Clinical Trials for Medicines: Apply for Authorisation in the UK

This guidance sets out how sponsors apply to the MHRA for clinical trial authorisation (CTA) of investigational medicinal products.

Key points:

• When a clinical trial is needed: If you plan to test an investigational medicinal product (IMP) in humans, you must obtain authorisation.

• Sponsor & legal representative requirements: The sponsor is responsible for initiation, management and financing of the trial. If the sponsor is based outside the UK, a UK legal representative may be required.

• Combined review: The guidance emphasises a single application through the Integrated Research Application System (IRAS), with parallel review by MHRA and a Research Ethics Committee (REC).

• Timelines: A valid application should receive a decision (approval / approval with conditions / rejection) within 30 calendar days of validation.

• Documents required: Cover letter, protocol, investigator’s brochure, informed consent forms, monitoring plan, IMP dossier, etc.

Why this matters:For pharma companies, this guidance lays out the operational roadmap for launching a UK clinical trial. Given the competitive landscape, efficient trial activation is a strategic advantage.

Takeaway for industry:

• Build your clinical trial regulatory strategy early—including CTA submission timeline, documentation preparation, and ethics review.

• Leverage combined review process to reduce duplication and time lag.

• Ensure your regulatory operations team tracks the “validation” phase and works to minimise queries and delays.

For industry players, aligning these two pathways—access and development—is key to success.

For more details, please refer to:

• Early Access to Medicines Scheme: Overview

• Clinical trials for medicines: apply for authorisation in the UK