Pre-submission Advice & Support for Innovative Medicines
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations and clinical variations innovative medicines.
Overview
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service to support prospective applicants before submission of applications. This service aims to provide appropriate support to applicants, regardless of the application route.
This guidance applies to:
- Initial Marketing Authorisation Applications (MAAs) for Innovative Medicines;
- Variation applications to introduce new indications; and
- Line extension applications.
For the purposes of this guidance, Innovative Medicines refer to new chemical active substances, all biological medicines (including biosimilars), medicines for orphan indications, medicines for rare diseases, and products seeking conditional approval or approval under exceptional circumstances.
Applicants intending to submit such applications must notify the MHRA of their intended submission date in advance, as outlined below.
Applicants may also request a pre-submission meeting to support preparation for a planned submission. These meetings are intended to support procedural and regulatory aspects and MHRA’s operational planning while providing an opportunity to introduce the product and planned submission approach to the MHRA.
Where a pre-submission meeting is not requested, but the MHRA deem it required, a pre-submission meeting is strongly advised prior to submission to ensure that appropriate expertise and resources are in place and to identify any procedural or logistical issues that could affect the handling of the application. Applicants are strongly encouraged to attend any pre-submission meeting requested by the MHRA. Failure to do so may increase the risk of validation issues or delayed validation and subsequent assessment of the application.
Pre-submission meetings may identify high-level considerations or areas requiring attention and are intended to support submission readiness. They do not constitute an assessment of the data package and must not be used to seek confirmation on the acceptability, adequacy, or sufficiency of specific scientific, clinical, or regulatory approaches.
Where applicants require MHRA views on the adequacy or acceptability of their data package, development programme or regulatory strategy, a formal Scientific Advice request should be submitted. For further information on scientific advice, please see Medicines: get scientific advice from the MHRA - GOV.UK.
Process and templates
Applications via the Direct National Route
Applicants intending to submit an MAA, a new indications variation or a line extension for an Innovative Medicine must notify the MHRA of their intended submission date at least 3 months in advance by completing and returning the pre-submission notification form below to presubmission@mhra.gov.uk.
Pre-submission Advice Form (MS Word Document, 262 KB)
Applicants are strongly encouraged to request a pre-submission meeting from the MHRA by indicating this in the form.
Requests will be considered by the MHRA, which may direct applicants to relevant guidance, provide written advice, or offer a pre-submission meeting.
If there are any questions or queries on the above documents and process, please direct these to presubmission@mhra.gov.uk.
Applications via the International Recognition Procedure (IRP)
Applicants intending to submit an MAA, a new indications variation or a line extension for an Innovative Medicine via the IRP route must notify the MHRA of their intended submission date at least 8 weeks in advance by completing the online IRP eligibility form and submitting the outcome to Recognition@mhra.gov.uk.
Applicants may also request a pre-submission meeting by completing the Pre-submission Advice Form - International Recognition Procedure below and returning it to presubmission@mhra.gov.uk. Requests will be considered by the MHRA, which may direct applicants to relevant guidance, provide written advice, or offer a pre-submission meeting.
Pre-submission Advice Form - International Recognition Procedure (IRP) (MS Word Document, 264 KB)
If there are any questions or queries on the above document/s and process, please direct these to presubmission@mhra.gov.uk.
For ACCESS and Orbis procedures
Applicants intending to submit an MAA, a new indications variation or a line extension for an Innovative Medicine through the ACCESS work sharing initiative or the project ORBIS procedure, must also notify the relevant teams as through the pages below:
If there are any questions or queries on the above document(s) and process, please direct these to presubmission@mhra.gov.uk.
Pre-submission meeting format
Pre-submission meetings are intended to support submission readiness by facilitating early regulatory dialogue on procedural, administrative and operational aspects of an application.
These meetings are not intended to review the scientific content of regulatory dossiers or detailed scientific data packages. Applicants should therefore not submit extensive briefing materials, full study reports or comprehensive scientific justifications. If scientific advice is required, a Scientific Advice Meeting should be requested (please see Medicines: get scientific advice from the MHRA - GOV.UK).
In pre-submission meetings, applicants should instead provide concise information in advance of the meeting to support effective discussion. This is limited to information necessary for understanding the proposed submission and does not require detailed argumentation. Proposed submission timelines and submission routes for the UK and other geographies should be included.
Applicants are required to submit the relevant pre-submission notification or meeting request form available on this page. This form provides the core administrative and product information required to support planning and scheduling of the meeting.
Applicants should also provide a concise presentation slide deck, typically consisting of 10-15 slides. The presentation should introduce the product, outline the proposed submission strategy, and highlight any key procedural or operational considerations relevant to submission readiness. It should also include specific regulatory points or regulatory questions intended for discussion at the meeting.
Additional supporting documentation is not routinely required. Where necessary, for example in cases involving complex regulatory pathways or novel product types, the MHRA may request limited additional information to support effective preparation for the meeting.
The MHRA will not routinely take formal minutes of pre-submission meetings. Applicants may take their own minutes and are encouraged to share them with the MHRA within 5 working days of the meeting. The MHRA will review the minutes and will not normally provide comments or amendments unless the MHRA considers that the minutes do not accurately reflect the discussion or that the applicant may have misunderstood the MHRA’s position. In these cases the MHRA will provide clarification.
Further information
For queries relating to information on other elements of MHRA services, please contact the relevant colleagues who will be able to assist:
- For general MHRA enquiries, including for medical devices, contact info@mhra.gov.uk
- For medicines regulatory support on all other matters, contact ris.na@mhra.gov.uk
- For e-cigarettes support, visit E-cigarettes: regulations for consumer products - GOV.UK
Updates to this page
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Updated guidance on pre-submission requirements for innovative medicines applications, including notification expectations, and circumstances where MHRA may require a pre-submission meeting
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Information on the webpage has been updated, along with the latest version of the Pre-submission Notification Form.
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First published.