Rolling review for marketing authorisation applications

Use the rolling review route when you want to submit your eCTD dossier in separate parts for pre-assessment instead of making a full consolidated document submission.

The rolling review is a new route for marketing authorisation applications (MAA), where an applicant for a marketing authorisation submits modules of the eCTD dossier incrementally for pre-assessment by the MHRA rather than as part of a consolidated full dossier submission.

The rolling review 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 development of innovative medicines.


Rolling review can be used for a new active substance (NAS) in the UK, Great Britain (England, Scotland and Wales), or Northern Ireland. This is in accordance with regulation 50(5) of the Human Medicines Regulations, or for a similar biological medicinal product in Great Britain in accordance with regulations 53A of the Human Medicines Regulations.

MAAs for any NAS based on a ‘full dossier’ are eligible for the rolling review. Biosimilar applications are also eligible for inclusion in the scheme.

How to apply

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.

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.

If you would like 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

Applications, including the first module(s) to be assessed, should be submitted through MHRA Submissions. You can find out more in our guidance about the MHRA submission portal.


Fees will be payable for each phase of assessment.

You can find out more about the fees we charge in the guidance MHRA fees.

You can find out more about how to pay your fees in our guidance Make a payment to MHRA.


Pre-assessment of modules

The assessment of the first module will start following validation of the application. The assessment 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 for each modular assessment.

The assessment process may include consultation with the CHM and/or therapy area experts during the pre-assessment process.

Before submission

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.

Pre-submission meeting

A pre-submission meeting with the MHRA around 90 days in advance of the intended submission for the final marketing authorisation application is recommended. 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.

Validation of applications (MAAs)

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)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.

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 final decision on approvability will be reached by Day 100. The orphan status will be determined at the time of grant of the marketing authorisation.


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.

The MHRA decision letter will detail the appeal process and timelines. If orphan status is not agreed and company may wish to appeal this decision, the grant of a marketing authorisation will only be possible when the appeal process is completed.


The granting of a marketing authorisation will lead to the publication of a Public Assessment Report for the product.

Published 31 December 2020