Pre-submission Advice & Support from the MHRA

Overview of the Service

The UK Medicines and Healthcare products Regulatory Agency (MHRA) provides a pre-submission advice and support service to stakeholders planning to submit a marketing authorisation application for medicines. This service helps applicants understand the regulatory requirements, submission process, and evidence expectations that apply to their product or application type. It is separate from MHRA’s scientific advice service, though both aim to improve the quality and success of regulatory submissions.
Source: Pre-submission Advice & Support (gov.uk)

Pre-submission advice is intended to clarify how to compile and submit applications and to identify potential regulatory or data gaps before an application is formally submitted.
Source: Pre-submission Advice & Support (gov.uk)

Who Should Request Pre-submission Advice

Applicants planning to submit new marketing authorisation applications, particularly those for New Active Substances or biological products, are encouraged to engage with MHRA’s pre-submission service. For such applications, a pre-submission meeting with the relevant MHRA teams should be requested at least three months before the intended submission date.
Source: Pre-submission Advice & Support (gov.uk)

How Applicants Request Advice

To request pre-submission advice, applicants must download and complete the relevant pre-submission advice form and return it to the MHRA via the designated email address (e.g., presubmission@mhra.gov.uk). The MHRA team will triage requests and provide guidance, written advice or offer a pre-submission meeting depending on the applicant’s needs.
Source: Pre-submission Advice & Support (gov.uk)

International Recognition Procedure

For applicants intending to submit via the International Recognition Procedure (IRP), there is a specific pre-submission advice form designed to support eligibility and preparatory discussions with the MHRA.
Source: Pre-submission Advice Form (IRP)

Other Submission Pathways

Applicants planning marketing authorisation through work-sharing initiatives such as ACCESS or Project Orbis should also use the pre-submission process to notify MHRA of their plans and to clarify expectations.
Source: Pre-submission Advice & Support (gov.uk)

Benefits of Early Engagement

Engaging with MHRA through pre-submission advice can help applicants:

• Understand regulatory expectations for their submission type and product.
• Identify data gaps or information needs that could cause delays.
• Clarify submission timelines and procedural pathways.
• Improve the completeness and accuracy of their application before formal submission.
  Source: MHRA Guidance: Pre-submission Advice & Support

Distinction from Scientific Advice

Pre-submission advice is distinct from MHRA’s scientific advice services, which focus on detailed scientific and clinical strategy questions (e.g., trial design, data interpretation). Scientific advice can be sought separately through MHRA’s scientific advice process.
Source: Medicines: get scientific advice from MHRA (gov.uk)

Practical Considerations

When planning to request pre-submission advice, applicants should:

• Prepare clear information on the product and proposed submission.
• Provide draft data summaries or questions the MHRA can address.
• Allow sufficient lead time (generally at least three months prior to submission) for MHRA to coordinate the appropriate support.
  Source: Pre-submission Advice & Support (gov.uk)

Conclusion

The MHRA’s pre-submission advice and support service is an important early-stage resource for medicine developers. By seeking guidance on submission requirements, regulatory expectations, and potential challenges well before formal filing, applicants can better prepare high-quality marketing authorisation applications that meet UK regulatory standards.
Source: Pre-submission Advice & Support (gov.uk)