Scope
Description
The Medicines and Healthcare products Regulatory Agency is the regulator of medicines, medical devices and blood components for transfusion in the UK. MHRA carries out a wide range of activities to fulfil its role as a patient safety regulator. This includes carrying out assessments of the safety, quality and efficacy of medicines, assessing the safety of proposed clinical trials of medicines and medical devices, inspecting the premises of those manufacturing, supplying or distributing medicines and monitoring the ongoing safety of all medical products, taking swift action where necessary to prevent harm to patients. The MHRA also engages with companies within the regulated sector to provide specific, scientific advice on the development of products. The aim of such advice is to ensure the developer understands the requirements of the regulator, ensuring that the developer can provide the required information to support a properly informed assessment.
With a wide range of critical deliverables, MHRA is seeking opportunities to add to its traditional in-house expertise through the establishment of additional sources of both capacity and capability. These will enable MHRA to deliver innovative, new and improved services at increased pace, safeguarding public health and supporting the growth of life sciences in the UK.
MHRA is seeking suppliers with the capacity and capability to deliver assessments of complex clinical and non-clinical regulatory data and provide carefully evidenced judgements within an MHRA assessment and quality assurance framework. Such assessments may relate to marketing authorisation applications, clinical trial applications and a variety of other compliance activities. Deployment of supplier resources will be on a flexible basis to enable MHRA greater discretion in flexing established capacity as needed to support increased growth in UK life sciences through new and improved advice and support services.
To achieve this ambition, MHRA wishes to establish a framework of specialist providers.
Commercial tool
Establishes a framework
Contract dates (estimated)
- 1 June 2026 to 31 May 2029
- Possible extension to 31 May 2030
- 4 years
Main procurement category
Services
CPV classifications
- 73000000 - Research and development services and related consultancy services
- 85148000 - Medical analysis services
Contract locations
- UK - United Kingdom
Engagement
Engagement deadline
23 January 2026
Engagement process description
MHRA will hold a virtual pre-market engagement event on Monday 26th January at 2pm inviting suitably qualified and experienced suppliers to attend a presentation by the Healthcare Quality and Access team where high-level information about the requirements will be shared followed by an opportunity to participate in a Q&A session.
The objective of this session will be to:
• Understand supplier appetite and opinion and gain an understanding on the viability of the concept
• Understand barriers, risks and issues and any potential innovative solutions
• Inform a high-quality specification, procurement strategy and the structure of the contract/framework
Suppliers are also invited to express their interest in a separate 1:1 engagement session immediately following the event to share any useful intelligence. Requests will be accommodated based on capacity and no guarantees are made.
Suppliers attending the event will not have any advantage over organisations who do not participate, and this market consultation is in no way a guarantee of future work. Material shared at this event including a summary of the Q&A will be made available as part of any future tender pack ensuring all participating suppliers have access to the same information.
Suppliers wishing to attend the event should email Commercial@MHRA.gov.uk to receive joining instructions.
Participation
Particular suitability
Small and medium-sized enterprises (SME)
Submission
Publication date of tender notice (estimated)
2 March 2026
Contracting authority
MHRA
- Public Procurement Organisation Number: PJLJ-9824-VXPG
10 South Colonnade, Canary Wharf
London
E14 4PU
United Kingdom
Contact name: Alison Finn
Email: commercial@mhra.gov.uk
Website: https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
Region: UKI42 - Tower Hamlets
Organisation type: Public authority - central government