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UK MHRA Guidances: 9 important Guidances on Clinical Trials Safety, Approvals, Labelling, and More

Clinical trials are the cornerstone of modern medicine, ensuring that new treatments are safe, effective, and suitable for public use. The UK has established a comprehensive regulatory framework under the Medicines and Healthcare products Regulatory Agency (MHRA) to guide sponsors, investigators, and stakeholders through every stage of a clinical trial.

This blog consolidates key guidance from the UK government on clinical trials for medicines, covering everything from approval and labelling to safety reporting and trial modifications.


1. Applying for Approval to Conduct Clinical Trials in the UK

To conduct a clinical trial in the UK, sponsors must apply through the Integrated Research Application System (IRAS). The MHRA assesses the application, focusing on safety, scientific rationale, and ethical standards.

Key points:

  • Use IRAS to submit a combined review application.

  • Secure both MHRA and Research Ethics Committee (REC) approvals.

  • Non-commercial and commercial trials follow the same legal framework but may have different practical considerations.


2. Expert Advice for Trial Design

Source: Expert Advice

MHRA encourages sponsors to seek expert scientific advice before initiating trials. This is especially useful for complex protocols, first-in-human studies, or trials involving advanced therapies.

What it includes:

  • Pre-submission meetings to clarify regulatory requirements.

  • Recommendations on study design, endpoints, and patient safety.


3. Labelling Requirements for Investigational Medicinal Products (IMPs)

IMP labelling is critical for trial integrity and participant safety. Labels must clearly identify the product, batch number, expiry date, and storage conditions.

Exceptions:

  • Hospital-prepared products used in the same location may be exempt from certain labelling standards.

  • Simplified labelling is possible in specific low-risk situations.


4. Notifiable Trials

Not all clinical studies require MHRA approval. Trials involving licensed medicines used within their marketing authorisation are typically non-notifiable.

Notifiable trials include:

  • Trials of unlicensed medicines.

  • Trials involving licensed medicines used off-label or in novel combinations.


5. Modifying a Clinical Trial Approval

Sponsors must report substantial amendments to trial protocols—such as changes in dosage, eligibility criteria, or trial sites—to MHRA and RECs.

Types of changes:

  • Substantial amendments: Require formal approval.

  • Non-substantial changes: Must be documented internally but not submitted for approval.


6. Ending a Clinical Trial

Sponsors must notify MHRA when a trial ends early or reaches completion.

Reporting requirements:

  • Submit a Declaration of the End of a Trial within 90 days (or 15 days if terminated prematurely).

  • A final study report must be submitted within one year.


7. Transitional Arrangements under the New Regulations

Following the EU-UK regulatory separation, transitional guidance ensures trials remain compliant during the shift from EU Clinical Trials Directive to UK-specific regulations.

Key considerations:

  • Existing EU-authorised trials can continue under transitional provisions.

  • New UK trials must align with MHRA’s Clinical Trials Regulation framework.


8. Use of Non-Investigational Medicinal Products (NIMPs)

NIMPs are substances used alongside IMPs but not under investigation themselves—such as rescue medications or background therapies.

Regulations specify:

  • NIMPs do not require MHRA approval but should be documented in trial protocols.

  • Sponsors must ensure their quality and safety.


9. Safety Event Reporting: Collection, Verification, and Submission

Source: Safety Events

Safety monitoring is one of the most critical aspects of a clinical trial. Sponsors are responsible for identifying, verifying, and reporting serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs).

Reporting mechanisms:

  • SUSARs must be reported to MHRA within 7–15 days depending on severity.

  • Annual safety reports are required for long-running studies.

MHRA’s evolving approach, including transitional arrangements post-Brexit and a focus on proportional regulation, continues to support innovation in drug development while safeguarding participants.


If you're involved in planning, conducting, or overseeing clinical trials in the UK, staying updated on these guidelines is not just recommended—it's essential.


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The views expressed in this publication do not necessarily reflect the views of any guidance of government, health authority, it's purely my understanding. This Blog/Web Site is made available by a regulatory professional, is for educational purposes only as well as to give you general information and a general understanding of the pharmaceutical regulations, and not to provide specific regulatory advice. By using this blog site you understand that there is no client relationship between you and the Blog/Web Site publisher. The Blog/Web Site should not be used as a substitute for competent pharma regulatory advice and you should discuss from an authenticated regulatory professional in your state.  We have made every reasonable effort to present accurate information on our website; however, we are not responsible for any of the results you experience while visiting our website and request to use official websites.

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