Clinical Trials for Medicines: Apply for Authorisation in the UK Publisher: MHRA (UK Medicines and Healthcare products Regulatory Agency)

For clinical trial sponsors and regulatory teams, understanding the UK’s clinical trial authorization process is essential. The Medicines and Healthcare products Regulatory Agency (MHRA) provides detailed guidance on how to apply for authorization to conduct clinical trials for medicines in the UK. 

Originally published in 2014, this guidance was most recently updated on 22 August 2025, reflecting the latest regulatory considerations including updates for In Vitro Diagnostic (IVD) and Companion Diagnostic (CDx) devices.

Whether you are running a simple Phase I trial or planning a complex study involving innovative designs or medical devices, navigating the CTA process effectively can save time, reduce compliance risks, and improve your likelihood of approval.

Clinical Trials and COVID‑19 Considerations

The MHRA guidance highlights how clinical trials are influenced by ongoing public health considerations, including lessons learned from the COVID‑19 pandemic. While sponsors must still follow established processes, the agency has emphasized flexibility and risk-proportionate approaches for trial management under exceptional circumstances.

When a Clinical Trial Authorisation (CTA) Is Needed

A CTA is required for any clinical trial of an investigational medicinal product (CTIMP) in the UK. MHRA guidance specifies which trials fall under this requirement, helping sponsors avoid unnecessary submissions while ensuring compliance for trials that do require authorization.

Trial Sponsor and Legal Representative

Sponsors are responsible for ensuring regulatory compliance and patient safety. For trials conducted in the UK, the guidance outlines requirements for both the trial sponsor and, if applicable, the legal representative, including responsibilities for submissions, trial conduct, and reporting.

Registration and Combined Reviews

MHRA encourages sponsors to register clinical trials in recognized databases and offers combined review options for studies that involve both a CTIMP and a medical device. This combined review process can streamline approval timelines and simplify coordination between regulatory and ethics committees.

In Vitro Diagnostic (IVD) and Companion Diagnostic Devices

One of the key updates in the 22 August 2025 guidance pertains to IVD and Companion Diagnostic Devices. This update clarifies regulatory expectations for clinical trials involving these devices, ensuring alignment with UK and international standards. 

Sponsors now have clearer instructions on when and how to submit trial applications for IVDs, including companion diagnostics, helping reduce delays and uncertainty during the approval process.

Documentation and Submission Assessment

The guidance provides a detailed list of required documents for CTA submissions, covering trial protocols, investigator information, and supporting safety data. MHRA outlines how submissions are assessed, highlighting common issues that can arise, such as incomplete documentation, unclear risk management strategies, or discrepancies in trial design. 

Sponsors are also reminded of the option to withdraw a submission before a final decision if revisions are needed.

Risk‑Proportionate Approaches and Innovative Designs

MHRA encourages a risk-proportionate approach to trial authorization. Sponsors conducting trials with complex or innovative designs, or trials requiring expert advice, can seek early guidance from the agency. 

This proactive approach can help mitigate regulatory hurdles and ensure trial protocols meet both safety and compliance standards.

Fees and Contact Information

Finally, the guidance outlines the applicable fees for clinical trial applications and provides direct contact points for sponsors who need additional support. Being aware of fees, timelines, and points of contact ensures sponsors can plan resources effectively and maintain open communication with regulators.

Conclusion

Navigating clinical trial authorization in the UK requires careful attention to MHRA guidance, especially with the recent updates for IVD and Companion Diagnostic Devices. By understanding requirements for CTAs, combined reviews, documentation, and risk-proportionate approaches, sponsors can streamline approval, reduce compliance risks, and focus on advancing innovative therapies to patients.

For organizations looking to simplify regulatory tracking and submission management, platforms like RegDesk can provide centralized oversight, automated reminders, and alignment with evolving guidance helping you stay ahead in the complex world of UK clinical trials.

Expanding the Pilot: What’s New in 2025

Health Canada’s newest pilot broadens eligibility, inviting manufacturers to participate voluntarily for new or significant change amendment submissions for Class III and Class IV devices, covering both in vitro diagnostic devices (IVDDs) and non-IVDDs. Unlike the prior pilot, this iteration introduces a conversion tool to adapt eSTAR content into the IMDRF Table of Contents folder structure. 

While priority may be given to IVDD submissions (previously excluded) only 30 participants will be selected based on eligibility factors and readiness. Importantly, devices must not be combination products, and only English-language eSTAR submissions are accepted at this time; French-language submissions are planned for rollout later.

How to Participate in the Pilot

Manufacturers interested in joining the pilot must prepare and submit:

• An email to [meddevices-instrumentsmed@hc-sc.gc.ca] with subject line: “Request for participation in eSTAR – HC pilot.”
• Details including manufacturer name, contact person, device trade name, corresponding PNC and GMDN codes, confirmation of a Class III/IV submission by end of 2025, whether it’s new or a significant change, and whether the device is IVDD or non-IVDD. 

Health Canada aims to respond within five business days, confirming acceptance and sharing an information package that includes the eSTAR template, project plan details, conversion tool instructions, and a short feedback survey for participants.

Preparing Your Submission: Practical Considerations

Once accepted into the pilot, applicants receive an info package and must watch for file constraints:

• File size guidance: Keep the eSTAR package under 1 GB, larger files may lead to processing delays. Media attachments like images or videos should be in compressed formats (e.g., JPEG, MP4), with ultra-high-definition content only included when absolutely necessary.
• Attachment management: Combine attachments of similar content into a single file (e.g., software specs), using tools like Adobe Acrobat Pro’s “Combine Files.” Include bookmarks or a table of contents to make navigation easier for reviewers.

Additional Aspects of the Pilot

• Responses to information requests: If Health Canada asks for additional information, those responses must follow the individual instructions provided (they are not submitted via eSTAR as part of the pilot).
• User fees and timelines: Fees remain the same as for standard submissions, and pilot submissions will adhere to the same review timelines as non-pilot counterparts.

Strategic Benefits for Industry

The eSTAR pilot brings several clear advantages to medical device sponsors:

1. Reduced administrative burden and improved submission accuracy thanks to automation and built-in validations.
2. Harmonization with FDA and IMDRF standards, aligning Canada’s process with international regulators.
3. Potential for more efficient reviews and fewer information requests.
4. Learning and influencing future policy , as Health Canada evaluates pilot outcomes and may mandate eSTAR for Class III/IV submissions in the future.

Looking Ahead: What’s Next for eSTAR in Canada

The pilot is planned  until the end of 2025, after which Health Canada will publish results and share lessons learned. Based on pilot success and feedback, eSTAR could become a mandatory format for high-risk device submissions, further embedding digital convergence in global regulatory frameworks.

Conclusion: Why This Matters and What to Do Next

Health Canada’s expanded eSTAR pilot is a critical step toward digital modernization and international alignment in medical device regulation. By simplifying submission preparation, driving consistency, and offering a pathway to mandatory adoption, eSTAR positions Canada at the forefront of interoperable, efficient regulatory processes.

For manufacturers preparing Class III or IV submissions before the end of 2025, now is the time to act: request participation, shape the pilot’s outcome, and gain valuable early insights into Canada’s evolving submission landscape.