Original Tender 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).