MHRA Regulatory Pathway
Medicines and Healthcare products Regulatory Agency — The United Kingdom's post-Brexit independent regulatory authority responsible for ensuring medicines, medical devices, and blood components meet applicable standards of safety, quality, and efficacy.
210 Days
Standard Review
150 Days
Accelerated Review
eCTD
Mandatory Format
ILAP
Innovation Pathway
Post-Brexit Regulatory Framework
Following the United Kingdom's departure from the European Union on 1 January 2021, the MHRA assumed full responsibility as the UK's standalone medicines regulator. Previously, the UK participated in the European Medicines Agency (EMA) centralised, decentralised, and mutual recognition procedures. Post-Brexit, the MHRA now operates an independent national licensing system, enabling the agency to set its own regulatory standards, review timelines, and approval criteria.
The UK has introduced several novel regulatory pathways to maintain its position as a global leader in medicines regulation. The agency has adopted an agile, risk-proportionate approach that leverages international partnerships and work-sharing agreements. The MHRA can now rely on assessments from trusted international regulators — including the FDA, EMA, Health Canada, and TGA — through its International Recognition Procedure, accelerating approvals for medicines already authorised in comparable jurisdictions.
Key Post-Brexit Change
EMA marketing authorisations are no longer valid in the UK. Sponsors must obtain a separate UK Marketing Authorisation from MHRA, even if they hold an EU-wide centralised authorisation. Existing EU authorisations were grandfathered into UK law during the transition period, but new products require independent UK submissions.
ILAP — Innovative Licensing and Access Pathway
The Innovative Licensing and Access Pathway (ILAP) is a flagship initiative introduced by MHRA to reduce the time to market for innovative medicines that address unmet medical needs. ILAP brings together MHRA, the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC), and the All Wales Therapeutics and Toxicology Centre (AWTTC) into a single, integrated framework.
Through ILAP, applicants receive an Innovation Passport — a designation granted to products demonstrating the potential to address a significant unmet patient need. Once the Innovation Passport is granted, a Target Development Profile (TDP) is created collaboratively between the applicant and the regulatory/HTA bodies. The TDP serves as a dynamic roadmap, outlining the evidence generation strategy required for both regulatory approval and health technology assessment.
Key Benefits of ILAP
Reduced time to market for innovative medicines through streamlined regulatory pathways
Early and continuous dialogue between MHRA and applicants throughout development
Tailored development plans based on specific product characteristics and target indications
Integration of real-world evidence and novel trial designs into regulatory assessments
Collaborative international engagement with other regulatory agencies (FDA, EMA, TGA)
Post-licensing evidence generation commitments to support ongoing benefit-risk evaluation
Submission Types
eCTD Requirement
eCTD is mandatory for all UK national submissions to the MHRA. All Marketing Authorisation Applications, variations, and renewals must be submitted in eCTD format via the MHRA Submissions portal. Non-eCTD submissions will not be accepted for new applications.
Rolling Review Process
The MHRA Rolling Review enables continuous, real-time assessment of regulatory submissions. This process is designed for situations where there is a significant public health need and allows applicants to submit data as it becomes available, rather than waiting for the entire dossier to be completed.
Initiation & Agreement
MHRA agrees to accept a rolling review based on public health need or urgency. A submission plan is established between the applicant and MHRA outlining the schedule for module submissions.
Modular Submission
The applicant submits completed sections of the eCTD dossier as data becomes available, rather than waiting for the complete package. Quality (Module 3), nonclinical (Module 4), and clinical data (Module 5) can be submitted in sequence.
Ongoing Assessment
MHRA reviewers begin assessing each submitted module immediately upon receipt. Questions and clarifications are addressed in real time, reducing delays that typically occur during a standard review cycle.
Final Submission & Decision
Once all modules are submitted and reviewed, MHRA conducts a final consolidated assessment. A regulatory decision is issued significantly faster than the standard timeline, often reducing the total review time by several months.
Key Regulations & Guidelines
Human Medicines Regulations 2012
Primary UK legislation governing marketing authorisations, manufacturing, and distribution of medicines
The Medicines Act 1968 (as amended)
Foundational legislation for medicines regulation in the UK, updated post-Brexit
MHRA Guidance on Applications
Detailed procedural guidance for MAA submissions to the UK national authority
ICH Guidelines (UK-adopted)
International harmonised guidelines adopted into UK regulatory framework
UK GMP/GDP Requirements
Good Manufacturing Practice and Good Distribution Practice standards for UK operations
Innovative Licensing and Access Pathway
ILAP framework for accelerating access to innovative medicines
MHRA Review Centres
Licensing Division
Responsible for evaluation of national MAAs
Vigilance & Risk Management
Post-market safety monitoring and pharmacovigilance
Inspectorate
GMP, GCP, GDP, and pharmacovigilance inspections
Clinical Trials Unit
Authorisation and oversight of UK clinical trials
Reference Document
MHRA Submission Guidance
Comprehensive guidance for regulatory submissions to the UK MHRA
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