GovWire

1. Overview

The?MHRA?offers a 150-day assessment timeline for all high-quality marketing authorisation applications (MAAs), aiming at accelerating the availability of medicines for patients in the UK.

Under this process, the?MHRA?will evaluate the application for a marketing authorisation and reach its opinion on approvability within 150 days of submission of a valid application.

2. Eligibility

The 150-day assessment procedure is available for all high-quality new MAAs submitted to the MHRA.

3. How to apply

You can apply for a marketing authorisation (MA) for new active substances and biosimilar products or existing active substances. All applications should be submitted through the?MHRA?submission portal.

You can find out more in our guidance about?the?MHRA?submission portal.

You should use?our?electronic application form (eAF)?and cover letter tool?to determine what information you need to include in your application. If you do not include the correct information your application will not be validated.

3.1 New active substances and biosimilar products applications

Companies intending to submit direct national marketing authorisation applications for new active substances and/or biological products must request a pre-submission meeting with the relevant teams at least 3 months before the intended application date. See guidance on pre-submissions.

The?MHRA?will operate a fixed submission date system to facilitate consultation with the Commission on Human Medicines (CHM) and will publish a set of dates to facilitate planning the submissions to coordinate with appropriate?CHM meeting dates.

Before you submit your application, you should read our guidance on?procedures for UK paediatric investigation plans (PIPs). A UK?PIP?compliance check (CC) should be completed 60 days before your intended submission.

For medicinal products presented or used with a device component, see guidance on regulating medical devices.

Access Consortium work-sharing procedures: If you are considering a national application for either a new active substance, a biosimilar product, or a new indication application, then the?MHRA?invites you to consider submission via an?access consortium work-sharing procedure. These procedures allow simultaneous submission to the UK, Australia, Canada, Singapore and/or Switzerland. Potential advantages to companies include:

• simultaneous submission for access to multiple markets

• streamlined process: internationally coordinated review to reduce duplication/burden, joint, consolidated lists of questions capturing the assessment of all agencies

• predictability: work-sharing and peer review between agencies, with pre-determined joint international milestones

• competitive timetables: standard procedure of 180 days (excluding stop-clocks)

• flexibility: module 1 will be different between jurisdictions, while minor differences in module 2-5 may also be accepted; separate sovereign decisions at end of procedure

• opportunity to make a contribution to innovation in the area of regulation

For further information, or to express an interest in an Access Consortium submission, contact?access-mhra@mhra.gov.uk.

3.2 Existing active substances applications

If you are applying for MA for an existing active substance (a substance that is not a new active substance) you should read our guidance on?choosing acceptable reference medicinal products for generic applications and/or bioequivalence (BE) studies. You should also refer to any?MHRA?product-specific BE guidance for applications. Until and including 31 December 2024, guidance applies only to applications for a GB MA (an application only for Great Britain). From 1 January 2025, the guidance will apply to UK-wide applications.

4. Validation

The assessment timetable for new active substances and biosimilar products or existing active substances will begin after the validation of the application.

4.1 New active substances and biosimilar products

You should submit a valid, full application for evaluation. The accompanying cover letter should detail the intention to seek orphan status or MA under exceptional circumstances as applicable.

A valid application/dossier should include common technical modules (CTD?modules 2-5) and a UK specific?CTD?module 1, consisting of an appropriate risk management plan (RMP), UK?PIP?CC?and/or compliance with UK orphan medicines requirements, when 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 in the?eCTD?structure.

Applications that refer to an?ASMF?should ensure that the file (including the restricted part) has already been submitted to?MHRA?and a suitable letter of access authorising?MHRA?to make reference to the confidential information in the restricted part of the?ASMF?should be provided.

4.2 Existing active substances applications

A valid application/dossier should include common technical modules (CTD?modules 2-5, as appropriate), a UK specific?CTD?module1, and an appropriate risk management plan.

Applications that refer to an?ASMF?should ensure that the file has already been submitted to?MHRA?or included in the submission.

5. Fees

Fees will be payable at the appropriate national rate. You can find out more about the fees we charge in the guidance?MHRA?fees.

Use the?Fees Calculator?to work out what the fee for your submission will be. You can find out more about how pay your fees in our guidance?Make a payment to?

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