150-day assessment for national applications for medicines

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

Under this process, the the MHRA will will evaluate the application for a UK, Great Britain (England, Wales and Scotland) or Northern Ireland marketing authorisation and reach its opinion on approvability within 150 days of submission of a valid application. application.

2. Eligibility Eligibility

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

3. How to apply apply

You can apply for a marketing authorisation (MA)(MA) for new active substances and biosimilar products or existing active substances. AllThere are different application processes but all applications should be submitted through the the MHRA submission portalSubmission Portal. .

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

You should use our electronicuse applicationour form (eAF) and and cover letter tool to 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. validated.

3.1 New active substances and biosimilar products applications applications

CompaniesWe intendingrecommend toyou submitemail directpresubmission@mhra.gov.uk nationalbefore marketingyou authorisationintend applicationsto forsubmit newan activeapplication. substancesYou and/orshould biologicaltell productsus mustthe requestintended adate pre-submissionof meetingsubmission withof the relevantdossier teamsand atwhether least 3 months before the intendedMAA applicationis date.to Seebe guidancesubmitted on pre-submissions.  

The MHRA will operate a ‘fixed submission date’ system to facilitateUK, consultationGreat withBritain the(England, CommissionScotland onand HumanWales) Medicinesonly, (CHM)or andNorthern willIreland publishonly.

If athe setapplication ofincludes datesNorthern toIreland, facilitatethen planningit themust submissionscomply to coordinate with appropriate CHMEU meeting dates. requirements.

Before you submit your application, you should read our guidance on on proceduresProcedures for UK paediatricPaediatric investigationInvestigation plansPlans (PIPs).

A UK UK PIP compliance compliance check (CC) should be completed 60 days before your intended submission.  

submission. For medicinal products presented or used with a device component, seeyou should read our guidance on regulating medical devices. .

MHRA will arrange a pre-submission meeting with you.

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

• simultaneousSimultaneous submission for access to multiple markets

  markets.

• streamlinedStreamlined process: internationallyInternationally coordinated review to reduce duplication/burden,duplication/burden. joint,Joint, consolidated lists of questionsquestions, capturing the assessment of all agencies

  agencies.

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

  milestones.

• competitiveCompetitive timetables: standardStandard procedure of 180 days (excluding stop-clocks) 

  stop-clocks).

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

  procedure

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

  regulation.

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

3.2

Pre-submission Existingmeeting

The pre-submission meeting applies to new active substances applications and biosimilar applications.

IfThe youpre-submission aremeeting applyingshould forbe MArequested forat anleast existing90 activedays substancebefore (athe substanceintended thatsubmission isdate. notThe meeting request should be made via email at presubmission@mhra.gov.uk

At the meeting applicants may wish to provide a short summary of the dossier to share their intentions and to verify the new active substance)substance youstatus. shouldThey readmay ourwant guidanceto on choosingraise acceptableany referencespecific medicinalissues productssuch as requests for:

• consideration for genericorphan applicationsMA
• conditional and/orMA
• MA bioequivalenceunder (BE)exceptional studies.circumstance

The Youmeeting shouldwill also referoffer opportunity to any discuss the arrangements for UK Compliance Check on PIPs. 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 product-specific will BEoperate guidancea for‘fixed applications.submission Untildate’ system to facilitate consultation with the Commission on Human Medicines (CHM) and includingwill 31publish Decembera 2024,set guidanceof appliesdates onlyto facilitate planning the submissions to applicationscoordinate forwith aappropriate meeting GBdates MAof CHM.

Existing (anActive applicationSubstances onlyapplications

If you are applying for MA in Great Britain).Britain From(England, 1Scotland Januaryand 2025,Wales) theyou should read our guidance willon applychoosing acceptable reference medicinal products for generic applications and/or bioequivalence (BE) studies.

You should also refer to UK-wideany applications. MHRA product-specific BE guidance for applications made only to Great Britain.

4. Validation Validation

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

4.1 New active substances and biosimilar products 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. applicable.

A valid application/dossier should include common technical modules (CTD modules modules 2-5) and a UK specific specific CTD module module 1, consisting of an appropriate riskRisk managementManagement planPlan (RMP), UK UK PIP  CC and/or and/or compliance with UK orphanOrphan medicinesMedicines requirements, when applicable. applicable.

The The SmPC/PIL may may be submitted as Word documents in the working documents folder. There is an option to put the UK specific specific SmPC  PIL/labelling/Labelling text/mock-ups in the UK specific folder which is available inwithin the the eCTD structure.  structure.

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

4.2 Existing activeActive substancesSubstances applications Applications

A valid application/dossier should include common technical modules (CTD modules modules 2-5, as appropriate), a UK specific specific CTD module1, module-1, and an appropriate riskRisk managementManagement plan. Plan.

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

5. Fees Fees

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

Use the the Fees Calculator to to work out what the fee for your submission will be.

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

6. Assessment  Assessment

6.1 New active substances and biosimilar products products

The assessment process includes consultation with the the CHM on on fixed dates each month. The The submission slots will will be linked to the dates of of CHM meetings. The meetings. The MHRA may may additionally wish to seek advice or input from therapy area experts (specialty expert groups) during the assessment process. process.

The assessment process will run in two phases totalling 150 days with an intervening clock-off period between phase I and phase II, if required. Assessment phase I will be completed 80 days after the clock starts. Issues arising or requiring clarification from the initial assessment will be raised with the applicant as a letter requesting further information (RFI) and should be addressed within the clock-offclock off period of 60 days. days.

Requests for extension of the clock-offclock off period for up to another 60 days may be granted only for exceptions. Applicants may contact the assessment team for discussing issues raised in the the RFI letter. letter. Assessment in phasephase-I I will also address eligibility for grant of orphan status. Phase II assessment will commence on receipt of the applicant’s responses. Applicants are recommended to contact the the MHRA Assessment Assessment Team in advance of the intended date of submission of response to align with with CHM meetings. meetings. Based on the assessment, the the MHRA will will provide a decision on approvability of the product by day 150. 150.

For new active substances and biosimilar products,products the orphan status will be determined at the time of MA grant. If orphan status is not agreed and the company wishes to appeal this decision, the grant of a marketing authorisation will only be possible when the appeal process is completed. completed.

6.2 Existing activeActive substancesSubstances applications Applications

The assessment process will run in two phases totalling 150 days with an intervening clock-off period between phase I and phase II, if required. Assessment phase I will be completed within 80 days after clock start. Concerns arising from the initial assessment will be raised with the applicant as a letter requesting further information (RFI). ).

MHRA will will seek advice from from CHM and/or and/or therapy area experts (specialty expert groups) during the assessment process, as required. All concerns must be fully addressed in the clock-offclock off period of 60 days. Requests for extension of the clock-offclock off for up to another 60 days may be granted under exceptions only. Applicants may contact the assessment team for discussing issues raised in the the RFI letter.  letter.

Phase II assessment will begin on receipt of the applicant’s responses. Based on the assessment, the the MHRA will will provide an opinion on approvability of the product by day 150, and if positive, will grant the MA. MA.

6.3 Appeals 

Appeals

If the the MHRA proposes proposes to refuse to grant the MA based on advice from 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 The MHRA decision decision letter will detail the appeal process and timelines. timelines.

6.4 Publication 

Publication

Conclusion of the assessment will lead to the publication of a UK publicPublic assessmentAssessment reportReport for the product. product.