Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

MHRA-NICE aligned pathway

United Kingdom · Medicines and Healthcare products Regulatory Agency · New drugs

Other routeHigh confidenceLast verified October 3, 2026

Review target

Not published

Legal time limit

Not published

Steps

2 requirements

Application fee

What is the MHRA-NICE aligned pathway in United Kingdom?

An optional way to line up the MHRA licensing decision with the NICE technology appraisal in England, so NHS access can start sooner. Each body still assesses the evidence on its own. New medicines expected to go through NICE appraisal; all therapeutic areas are eligible.

What are the steps of the MHRA-NICE aligned pathway?

1. Register on UK PharmaScan; 2. Confirm commitment to NICE; 3. Submit to NICE and the MHRA; 4. Aligned decisions.

Outcome: NICE guidance published at the same time as the marketing authorisation.

Legal basis: Coordination between the MHRA licensing process and NICE technology appraisal

How the pathway works

Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).

ApplicantRegulatorCertification bodyCommitteeClock stopped

Timeline with clock stops

Official step durations

Approvals per year, other route in United Kingdom

From the official approvals data of this market, all products of this pathway type and segment

Steps

In order, with the official target for each step

1. Register on UK PharmaScanThe medicine is registered on the national horizon scanning database at least 3 years before the expected authorisation.
2. Confirm commitment to NICEAt topic selection the company confirms it can meet the NICE timelines. There is no separate application.
3. Submit to NICE and the MHRAFor the best timing, the NICE submission is about 7 months before the expected authorisation. Each body decides independently.
4. Aligned decisionsNICE publishes its appraisal to coincide with the MHRA marketing authorisation.

Requirements

What the applicant must provide or meet

Other

UK PharmaScan registrationRegistration at least 3 years before the expected authorisation is essential.
Optional and open to all areas(optional)

Official time targets

Targets, not actual review times

No time targets published.

Fees

Official amounts in the local currency

Fee	Amount
No fees published.

Other routes in United Kingdom: National assessment for innovative medicines, National assessment for established medicines, Generic medicine application, Biosimilar application, Well-established use application, Reclassification to pharmacy or general sale, International Recognition Procedure, Recognition A, International Recognition Procedure, Recognition B, Project Orbis (cancer medicines), Conditional marketing authorisation, Authorisation under exceptional circumstances, Orphan designation, Early Access to Medicines Scheme (EAMS). See all routes on the or explore them in the .

Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (9 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.