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How MHRA Regulatory Guidance Unlocks Post‑Brexit Pathways for Biotech and Pharma

"UK medicines and regulatory documents representing the role of the Medicines and Healthcare products Regulatory Agency (MHRA)

The UK’s split from the EU forced biotech and pharma companies to reckon with a brand-new regulatory landscape. No longer riding the EMA’s coattails, they now confront fresh hurdles and fresh chances. With MHRA regulatory guidance firmly in command, firms that grasp the new game plan can hit UK markets faster and stronger. This article presents a clear-eyed, section-by-section breakdown of post‑Brexit routes, from national marketing authorisations to the International Recognition Procedure, clinical trials, packaging and more. 

Along the way, you’ll pick up under‑discussed facts, like the MHRA clearing 1,100+ backlogged MAAs after losing 20% of its headcount and learn exactly how to align GMP/GDP compliance, quality assurance and strategic timing to win UK regulator approval.

MHRA as the UK’s Independent Regulator

Following Bre­xit’s December 2020 transition, the MHRA became Britain’s standalone agency, with no EMA safety net or EU-funded assessments. That leaner, UK-controlled path meant the MHRA lost about 20% of its workforce. Yet today it holds full autonomy, crafting MHRA regulatory guidance to embrace flexibility and speed.

Why this matters to you:

  • Responsibility: All marketing authorisations, clinical trial approvals and batch releases are MHRA-governed now.
  • Flex and Scale: Alignment with GMP, GDP and labelling rules still mirrors EU, but the MHRA can diverge when needed.
  • Opportunity: Becoming independent enables new fast-tracks like ILAP, rolling reviews and parallel global reviews.

If you’re operating in Great Britain (GB), you’re playing by MHRA’s rules exclusively. Northern Ireland still follows a hybrid under the NI Protocol, though Windsor Framework tweaks are set to change that. Recognising this, laying the table sets the stage for your regulatory map.

Route 1: National Marketing Authorisations via MHRA

MHRA retains the classic route – file a national Marketing Authorisation Application, undergo dossier checks, roll through the 150‑day review and secure approval. Not exciting? Think again. A host of recent promos reshapes this path:

  • Rolling reviews improve data submissions.
  • Accelerated 150‑day timelines let innovative products cross the finish line faster.
  • Scientific Advice from MHRA reduces regulatory uncertainty before filing.

Key steps:

  1. Dossier prep: Align content with UK-specific CMC, safety and benefit–risk balance.
  2. Qualified Person (QP): Ensure a UK-based QP signs off under GDP and GMP standards.
  3. Fees and Submissions: Costs differ slightly from EMA – factor in hidden fees for national and NI labelling.
  4. Assessment and Queries: Respond swiftly – MHRA timelines are tight.

Watchpoints:

  • Duplication of EMA and MHRA filings eats up resources.
  • Fleet retraining and UK QP certs are non-negotiable.
  • MHRA slowness may crop up, with its “capacity and predictability” rank as top concerns per ABPI.

Route 2: International Recognition Procedure (IRP)

Launched January 1, 2024, the IRP enables MHRA to fast-track approval by leaning on trusted regulators’ decisions, such as EMA, FDA and PMDA.

The lowdown:

  • Coverage: Products already approved across the USA, EU, Japan, Canada, Australia, Singapore and Switzerland.
  • Timing: IRP slots shrink to 60–110 days, compared to the standard 150. Some even hit 30 days, e.g. XGEVA (denosumab).
  • Eligibility Checker: An online tool launched Nov 20, 2023, lets you vet your file ahead to choose Route A or B.

IRP advantages:

  • No duplication – if FDA or EMA clears you, the UK follows suit.
  • Cost efficiency via reliance on external evaluations.
  • Strong supply-demand timing: XGEVA signalled the first IRP approval in 30 days.

Beware:

  • MHRA retains final say – if evidence is weak, they’ll reject.
  • File the checker early – don’t wait until the full dossier is ready.
  • Compliance with UK-specific criteria (labelling, QP release, packaging) remains critical.

Under-discussed fact: The first IRP fast-track product launched via FDA-to-UK, a rare immune disease therapy, in under five months.

Route 3: ILAP + Global Collaborative Reviews

The Innovative Licensing and Access Pathway (ILAP) is MHRA’s replacement for the EU’s PRIME. It’s meant to fast-track highly innovative therapies that address unmet needs.

What ILAP offers:

  • Early MHRA–Industry guidance on study design, CMC and health economics.
  • Combined development and payer angle, with NHS involvement at the outset.
  • Parallel, multi-regulator review – Access Consortium and Project Orbis widen the reach with concurrent filings.

Why ILAP matters:

  • Speed: A single rolling dossier, real-time queries and improved tech-assessment input.
  • Access alignment: NHS AND NICE prep begins during scientific advice – no waiting post-approval.
  • Prestige: MHRA sees success – CRISPR-based drug cleared in 2023 under ILAP pilots.

Bonus fact: MHRA participated in an international pilot for GMP single inspection around 2023, which is a rare cross‑regulator audit initiative.

Prep pointers:

  • Assemble a cross-functional team covering regulatory, quality assurance and health economics.
  • Request scoping scientific advice early, 6–9 months before the expected dossier freeze.
  • Build a dual labelling and packaging strategy and update the QP release process.

Route 4: Clinical Trials in GB – MHRA Submission and Approval 

Post-Brexit rules for UK clinical trials took effect in Jan 2021. Simplified approvals, a 60‑day compliance target and more digital interaction define the new scheme.

  • Backlog cleared, with MHRA eliminated ~1,000 trial applications – meeting 98% of 60‑day benchmarks.
  • New draft laws are expected by March 2026 to refine processes further.
  • GDP/GMP inspection standards must be in place before the site starts dosing – deviations result in immediate holds.

Clinical trial compliance must include:

  • UK-based QP release for IMPs.
  • Risk proportionate approaches for remote monitoring and eConsent.
  • Patient notification: Use of the MHRA Yellow Card scheme for AEs from day one.

Under-discussed fact: MHRA cleared 1,000 trial backlogs while cutting its team by 20% – indicative of early operational strain yet strong recovery.

Route 5: Post‑Approval Compliance – Packaging, Labelling and FMD

Getting approval isn’t the end. Make or break compliance often comes in the final mile – packaging, GDP storage, FMD and NI labelling.

Key obligations:

  • “UK Only” labels are required from Jan 1, 2025, under the Windsor Framework.
  • Falsified Medicines Directive (FMD) no longer applies in GB – barcodes are optional unless you’re operating in NI or the EU.
  • Northern Ireland (NI) still follows FMD, like joint-packs (GB+NI), which must meet both labelling systems.
  • GDP must be audit-ready: UK‑site QP sign‑offs, secure documentation and traceability are mandatory.

Bullet compliance checklist:

  • Final draft UK labelling vs. NI/EU versions
  • QP records and sign-offs are stored securely
  • Packaging printers verified for Windsor compliance
  • FMD barcode handling system (yes or no?) based on territory

Missed deadlines = supply disruptions. Customs checks alone delayed medicines at the NI border by two weeks for some, underlining the stakes.

Risk Radar – Roadblocks and Regulatory Hotspots

Your greatest enemy isn’t competition. It’s a compliance failure. Here’s where firms trip up:

  • Duplication burnout: EMA + MHRA dual filings raise costs.
  • Labelling deadlines: Margins collapse if artwork doesn’t align by Jan 2025.
  • MHRA bandwidth issues: ABPI flagged “capacity and predictability” as top concerns.
  • QP location mandates: No UK QP? No go.
  • IRP misfires: Docs must meet MHRA criteria even if FDA-approved.
  • NI splits: Confusion over labelling can lead to shipment holds.

A robust risk checklist must include internal audits on MHRA readiness and contingency planning for delays.

Tactical Playbook – Action Plan You Can Use Today

Here’s your step‑by‑step book of tactical moves:

  1. Plan file submissions early. Parallel EMA–MHRA submissions prevent delays.
  2. Use specialised compliance software. Track QP release, labelling versions and GDP records.
  3. Run the IRP eligibility tool 8–12 weeks before filing to pick the A or B route.
  4. Engage IMMEDIATELY with MHRA scientific advice. It leads to fewer hold-ups later.
  5. Build a full audit trail. QP docs, batch records and packaging artwork logs maintain clear traceability.
  6. Prep for NI/GB split. Create dual artwork files, print distinct packs and manage stock routes proactively.

These moves keep your team ahead, your product ready and regulatory friction minimal.

3 Under‑Discussed Facts You Need to Know

These hidden wins show what’s possible when you map your strategy to MHRA’s smart playbook.

  • The MHRA cleared 1,100+ national MAAs and 1,000 trial applications after major staff cuts.
  • The XGEVA IRP approval happened in just 30 days – the fastest yet.
  • MHRA took part in a pilot for cross‑regulator GMP single inspections – a rare international audit move.

Final Thoughts

The UK’s MHRA regulatory guidance offers multiple, overlapping paths – national MAAs, IRP, ILAP, clinical trials and packaging compliance. Each has its own logic and deadline. Done right, the reward is faster access to NHS patients and more predictable market entry. Done wrong, you get delays, lost stock and wasted resources.

Ready to Secure UK Approvals?

Don’t leave UK market access to chance. Inglasia offers expert teams fluent in MHRA regulatory guidance, IRP navigation, GMP/GDP compliance, trial filings and labelling strategy. We’ve guided dozens of biotech and pharma teams through MHRA’s toughest paths, so your product spends less time in review and more time helping patients.

Schedule a consultation with our experts today. Gain clarity. Save time. Launch with confidence.