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Medicines Licensing Assessor Services
Country:
United Kingdom of Great Britain and Northern IrelandSector:
Health and social work servicesDeadline:
6 Aug 2026AI Summary
The Medicines and Healthcare products Regulatory Agency (MHRA) seeks to enhance its in‑house expertise with additional external providers capable of delivering rigorous assessments of regulatory data for medicines, medical devices and blood components. The provider network will expand MHRA’s capacity to analyse complex clinical, non‑clinical and quality information, thereby ensuring that marketing authorisation applications, clinical trial applications and other compliance activities meet the agency’s safety and efficacy standards and support the growth of the UK life sciences sector.
To achieve this, MHRA is issuing a framework contract divided into three distinct lots. Lot 1 covers the assessment of pharmaceutical and quality data in accordance with Module 3 and the quality sections of Module 2 of the Common Technical Document; Lot 2 addresses the evaluation of clinical, statistical and clinical pharmacology information under Module 5 and the clinical sections of Module 2; and Lot 3 focuses on non‑clinical data assessment per Module 4 of the Common Technical Document. Each lot will award up to four suppliers, with flexible deployment of resources to enable the regulator to adjust capacity in response to growing demand. Award decisions will consider commercial, technical and social value criteria in balanced proportions.
All assessment activities must comply with the relevant sections of the Common Technical Document and adhere to the highest standards of quality and evidence-based judgement.
To achieve this, MHRA is issuing a framework contract divided into three distinct lots. Lot 1 covers the assessment of pharmaceutical and quality data in accordance with Module 3 and the quality sections of Module 2 of the Common Technical Document; Lot 2 addresses the evaluation of clinical, statistical and clinical pharmacology information under Module 5 and the clinical sections of Module 2; and Lot 3 focuses on non‑clinical data assessment per Module 4 of the Common Technical Document. Each lot will award up to four suppliers, with flexible deployment of resources to enable the regulator to adjust capacity in response to growing demand. Award decisions will consider commercial, technical and social value criteria in balanced proportions.
All assessment activities must comply with the relevant sections of the Common Technical Document and adhere to the highest standards of quality and evidence-based judgement.
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, which cover 3 Lots. Up to four suppliers, who meet the minimum criteria, may be awarded a place on each Lot.
Lot 1: Pharmaceutical Assessment: Assessment of pharmaceutical/quality data (in compliance with Module 3 and Module 2 (sections relevant to Quality) of the Common Technical Document).
Lot 2: Medical Assessment: Assessment of clinical, statistical and clinical pharmacology data (in compliance with Module 5 and Module 2 (sections relevant to Clinical) of the Common Technical Document).
Lot 3: Non-Clinical Assessment: Assessment of non-clinical data (in compliance with Module 4 of the Common Technical Document).
Communication: Bidders should access the Health Family e-tendering portal to access the full-set of requirements and to submit any tender. Interested suppliers https://atamis-1928.my.site.com/s/Welcome
Languages in which tenders or requests to participate may be submitted: En
Enquiry deadline: 2026-07-21T12:00:00+01:00
Submission address and any special instructions: Bidders should access the Health Family e-tendering portal to access the full-set of requirements and to submit any tender. Interested suppliers https://atamis-1928.my.site.com/s/Welcome
Tenders may be submitted electronically: allowed
Award decision date (estimated): 2026-10-01T23:59:59+01:00
Lot number: 1
Description: Assessment of pharmaceutical/quality data (in compliance with Module 3 and Module 2 (sections relevant to Quality) of the Common Technical Document).
Lot value (estimated)
5.000.000,00 GBP excluding VAT
6.000.000,00 GBP including VAT
This contract is subject to renewal: Yes
Description of renewals: The MHRA has the option to extend the Framework Contract by up to 1 year.
Lot number: 2
Description: Assessment of clinical, statistical and clinical pharmacology data (in compliance with Module 5 and Module 2 (sections relevant to Clinical) of the Common Technical Document).
Lot value (estimated)
4.000.000,00 GBP excluding VAT
4.800.000,00 GBP including VAT
This contract is subject to renewal: Yes
Description of renewals: The MHRA has the option to extend the Framework Contract by up to 1 year.
Lot number: 3
Description: Assessment of non-clinical data (in compliance with Module 4 of the Common Technical Document).
Lot value (estimated)
1.000.000,00 GBP excluding VAT
1.200.000,00 GBP including VAT
This contract is subject to renewal: Yes
Description of renewals: The MHRA has the option to extend the Framework Contract by up to 1 year.
Award criteria:
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, which cover 3 Lots. Up to four suppliers, who meet the minimum criteria, may be awarded a place on each Lot.
Lot 1: Pharmaceutical Assessment: Assessment of pharmaceutical/quality data (in compliance with Module 3 and Module 2 (sections relevant to Quality) of the Common Technical Document).
Lot 2: Medical Assessment: Assessment of clinical, statistical and clinical pharmacology data (in compliance with Module 5 and Module 2 (sections relevant to Clinical) of the Common Technical Document).
Lot 3: Non-Clinical Assessment: Assessment of non-clinical data (in compliance with Module 4 of the Common Technical Document).
Communication: Bidders should access the Health Family e-tendering portal to access the full-set of requirements and to submit any tender. Interested suppliers https://atamis-1928.my.site.com/s/Welcome
Languages in which tenders or requests to participate may be submitted: En
Enquiry deadline: 2026-07-21T12:00:00+01:00
Submission address and any special instructions: Bidders should access the Health Family e-tendering portal to access the full-set of requirements and to submit any tender. Interested suppliers https://atamis-1928.my.site.com/s/Welcome
Tenders may be submitted electronically: allowed
Award decision date (estimated): 2026-10-01T23:59:59+01:00
Lot number: 1
Description: Assessment of pharmaceutical/quality data (in compliance with Module 3 and Module 2 (sections relevant to Quality) of the Common Technical Document).
Lot value (estimated)
5.000.000,00 GBP excluding VAT
6.000.000,00 GBP including VAT
This contract is subject to renewal: Yes
Description of renewals: The MHRA has the option to extend the Framework Contract by up to 1 year.
Lot number: 2
Description: Assessment of clinical, statistical and clinical pharmacology data (in compliance with Module 5 and Module 2 (sections relevant to Clinical) of the Common Technical Document).
Lot value (estimated)
4.000.000,00 GBP excluding VAT
4.800.000,00 GBP including VAT
This contract is subject to renewal: Yes
Description of renewals: The MHRA has the option to extend the Framework Contract by up to 1 year.
Lot number: 3
Description: Assessment of non-clinical data (in compliance with Module 4 of the Common Technical Document).
Lot value (estimated)
1.000.000,00 GBP excluding VAT
1.200.000,00 GBP including VAT
This contract is subject to renewal: Yes
Description of renewals: The MHRA has the option to extend the Framework Contract by up to 1 year.
Award criteria:
| Name | Type | Weighting |
|---|---|---|
| Commercial | price | 30% |
| Technical | quality | 30% |
| Lot Specific Technical | quality | 30% |
| Social Value | quality | 10% |
| Social Values | quality | 10% |
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