Last updated: 4 April 2025
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This post is an attempt to present the guidance on MAAs based upon a rolling review, in a Q&A format.
Always read the guidance on this procedure published on the MHRA website for the most up to date and complete information.
What is the rolling review?
It is a route for marketing authorisation applications (MAA), where an applicant submits increments of the eCTD dossier for pre-assessment by the MHRA rather than as part of a consolidated full dossier submission.
How does a rolling review help in the development of medicine?
It is intended to streamline the development of novel medicines by offering periodic enhanced regulatory interaction and advice to reduce the risk of failure at the final phase and may be integrated with the Target Development Profile (TDP) to provide a clearer pathway for the development of innovative medicines.
Which products are eligible for a rolling review?
Rolling review can be used for a “full dossier” new active substance (NAS) in the UK or for a similar biological medicinal product (a biosimilar).
Supporting data requirements for a new active substance are unchanged from those set out in regulation 50(5) of the Human Medicines Regulations, or for a biosimilar in regulations 53A (for Great Britain) or 53B (for UK) of the Human Medicines Regulations.
Where in the UK are marketing authorisations granted via the rolling review applicable?
From 1 January 2025 Windsor Framework was implemented on 1 January 2025, the MHRA licenses new active substances and biosimilars UK-wide and the rolling review process is available for UK-wide applications.
What fees will be charged for the application?
Fees will be payable for each phase of assessment.
Find out more about the fees charged in the guidance: MHRA fees.
Find out more about how to pay your fees in the guidance: Make a payment to the MHRA.
Pre-submission steps
Pre-submission meeting
- A pre-submission meeting with the MHRA around 90 days in advance of the intended submission date for the final phase is recommended.
- Applicants intending to use the rolling review you should request a pre-submission meeting to discuss the product, its intended target populations and the data in each module to be submitted.
- To apply for a pre-submission meeting, a completed application should be sent to presubmission@mhra.gov.uk.
- At the meeting applicants may wish to provide a short summary of the dossier, as well as to raise any special issues such as requests for consideration for orphan MA, conditional MA or MA under exceptional circumstances.
- The pre-submission meeting may offer the opportunity to enhance joint discussion with the National Institute for Health and Care Excellence (NICE) Health Technology Assessment (HTA) evaluation process.
- The MHRA will operate a ‘fixed submission date’ system to facilitate consultation with the Commission on Human Medicines and will publish a set of submission dates to facilitate planning the submissions and coordinate with appropriate meeting dates of CHM.
PIPs and UK compliance check
Applicants should refer to guidance on Procedures for UK paediatric investigation plans (PIPs) and the UK compliance check (CC) should be completed 60 days before the intended submission.
Submission and validation
Submission
- The process is a modular approach to submission and evaluation.
- The quality, non-clinical and clinical data may be submitted separately or jointly, depending on individual circumstances and/or data availability, in the format of common technical modules CTD modules 3-5.
- Applications, including the first module(s) to be assessed, should be submitted through the portal, MHRA Submissions. Read the guidance about using the MHRA submission portal.
Validation
A valid application/dossier should include submission of any unassessed modules or data, which may include:
- the clinical module,
- UK specific CTD module 1, consisting of an appropriate Risk Management Plan (RMP), UK CC and/or orphan designation application (if applicable).
- The SmPC/PIL may be submitted as word documents in the working documents folder. There is an option to put the UK specific SmPC/ PIL/ Labelling text/ mock-ups in the UK specific folder which is available within the eCTD structure.
The assessment clock will begin after validation of the application.
Pre-assessment of modules
- The assessment:
- of the first module will start following validation of the application
- cycle will be completed within 60 days.
- Following each assessment cycle, a Module Assessment Summary (MAS) will be issued by Day 60.
- The MAS will offer the applicant opportunities to update the module which should be included in the final (marketing authorisation application) phase.
- The same timeline above will be applied to other module assessments.
The assessment process may include consultation with the CHM and/or therapy area experts (specialty expert groups) during the pre-assessment process.
Final phase assessment
- The final phase should be completed within 100 days in two stages as 60 + 40 days with an intervening clock off period.
- If required, a letter requesting further information (RFI) may be issued by Day 60 with the clock stopped.
- Applicants will have the opportunity to discuss any issues identified with the MHRA within 30 days.
- Once the RFI response is received, the clock will resume on Day 61, and the EAG/CHM will be consulted again with the final decision on approvability reached by Day 100.
- The orphan status will be determined at the time of grant of the marketing authorisation.
Appealing a decision to refuse
- If the MHRA proposes to refuse to grant the MA based on advice from CHM, there is an opportunity for the applicant to request a review of the decision.
- The procedure for such review is set out in Schedule 5, and paragraph 11 of Schedule 11, to the Human Medicines Regulations 2012.
- The MHRA decision letter will detail the appeal process and timelines.
- If orphan status is not agreed and the applicant company may wish to appeal this decision, the grant of a marketing authorisation will only be possible when the appeal process is completed.
Publication
The granting of a marketing authorisation will lead to the publication of a public assessment report for the product.
Source: MHRA website