UK's Medicines and Healthcare products Regulatory Agency (MHRA) updated and released (1 October 2024) guidance "Pre-Submission Advice and Support" to applicants seeking regulatory approvals for medicines, clinical trials, and medical devices in the UK. This guidance plays a crucial role in helping applicants navigate the complex regulatory landscape and ensures submissions are compliant with UK regulations, thus avoiding delays in approvals and market access.
Pre-submission advice is a service that provides stakeholders with the means to understand how the process of compiling and submitting applications and supporting evidence applies to their product/s. It is distinct from MHRAs Scientific Advice offering. This service helps address potential regulatory issues, clarify the requirements, and ensure applications are as complete and accurate as possible, thereby increasing the likelihood of a timely approval.
The MHRA’s pre-submission advice service is vital for applicants because it enables them to:
Identify and address gaps in data and documentation before formal submission.
Clarify complex regulatory requirements such as clinical trial design, data presentation, and product classification.
Receive feedback early, which helps avoid common pitfalls that could lead to rejection or delays.
Ensure that the application format and content are consistent with the expectations of the MHRA, avoiding unnecessary administrative hurdles.
To submit marketing authorization applications for New Active Substances and/or Biological Products, companies must request a pre-submission meeting with the relevant teams at least three months in advance.
Presubmission@mhra.gov.uk is the best place to ask for advice regarding new indications and line extensions. MHRA will advise on the most appropriate route to take. The MHRA request that this form be completed at least three months before submission and sent to the same mailbox for new indications and line extensions. Advice can be requested, but is not mandatory.
Applicants intending to submit Marketing Authorisation Applications for New Active Substances and/or Biological products or applications for new indications through the ACCESS work sharing initiative or the project ORBIS procedure.
In order to request pre-submission advice from the MHRA for applicants intending to submit via the International Recognition Procedure, please submit the form below and return it to presubmission@mhra.gov.uk. These requests will be assessed and the MHRA will either direct you to the relevant guidance, provide written advice or schedule a pre-submission meeting.
By engaging early and seeking regulatory guidance, applicants can increase their chances of timely and successful submissions while avoiding costly delays and rejections.
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