A quick guide for life sciences companies
- Marketing authorisations in the UK are governed by the Human Medicines Regulations (SI 2012/1916).
- Applications are made electronically through the Medicines and Healthcare products Regulatory Agency (MHRA) Submissions Portal.
- The process from application to authorisation generally takes up to 210 days, excluding time taken to provide any additional information or data required by the MHRA.
UK assessment routes
There are various routes to marketing authorisation in the UK, which we summarise below.
|150-day assessment route|
The MHRA will evaluate a UK, Great Britain (England, Wales and Scotland) or Northern Ireland marketing authorisation (MA) application and reach an opinion within 150 days of a valid application being submitted.
Available for “all high-quality new MA applications submitted to MHRA”.
|Innovative Licensing and Access Pathway (ILAP)||Aims to accelerate the time to market for new medicines that treat life-threatening or seriously debilitating conditions or where there is a significant patient or public health need, provided it meets the criteria.|
|"Rolling review" route of evaluation for novel products and bio-technological products|
Aims to reduce the risk of failure at the final phase of the application.
Modules of the online application are submitted at different stages for pre-assessment by the MHRA, rather than as a full submission.
UK's reliance on an MA granted by another jurisdiction
A European Commission Decision reliance procedure (ECDRP)
A decentralised and mutual recognition reliance procedure (MRDCRP)
Unfettered access procedure
The MHRA may rely on European Commission (EC) approvals under the European Union (EU) centralised procedure.
This route was due to expire on 31 December 2022, but has been extended until 31 December 2023.
The MHRA may rely on an approval of any member state of the EU or European Economic Area.
Allows GB approval of medicines with an existing MA covering Northern Ireland.
Other types of MA
|Conditional MA (GB)||MA under exceptional circumstances (GB)|
For medicines where a comprehensive data package cannot be provided, because:
Applicants must discuss their submissions with the MHRA prior to submitting their application.
"A framework for concurrent submission and review of oncology products"
It is also possible to obtain an MA through international collaborations such as Project Orbis. At the end of a review conducted as part of Project Orbis, a participating country may grant a national MA. This is the country’s decision.
Countries involved include: Australia, Brazil, Canada, Israel, Singapore, Switzerland, UK and US
|Project Orbis was initiated in May 2019, with the MHRA joining on 1 January 2021||Coordinated by the US Food and Drug Administration||Each country remains fully independent on their final regulatory decision||73 procedures have been started so far, with nine currently ongoing|
Changes on the horizon - Spring Budget
The UK government’s Spring Budget 2023 included a number of positive announcements for the MHRA, which should help to streamline and shorten the application routes for MAs, including:
|Extra funding||New model|
The Spring Budget provides an extra £10m funding for the MHRA over the next two years to accelerate patient access to treatments.
|The government also announced that from 2024, the MHRA will move to a different model to allow what they described as rapid, and often near automatic sign-off for medicines and technologies already approved by trusted regulators in other parts of the world such as the US, Europe and Japan.|