United Kingdom - Briefings

The Access Consortium is a collaboration of five national regulatory agencies (MHRA, TGA, Health Canada, HSA, and Swissmedic) that work together to align regulatory processes and reduce duplication in drug evaluations. Its purpose is to enhance international cooperation, ensuring timely access to high-quality, safe, and effective therapeutic products across member countries.

The All Wales Medicines Strategy Group conducts health technology assessments to evaluate new and existing medicines for use in NHS Wales. The main aim of this process is to ensure that patients in Wales have timely access to safe, effective, and cost-efficient medicines. This briefing describes the AWMSG appraisal process, which typically follows a structured procedure that involves submission, evaluation, and final recommendations.

The Cancer Drugs Fund (CDF) is a funding mechanism established in England to provide patients with access to cancer treatments that are not routinely available through the National Health Service (NHS).

The Early Access to Medicines Scheme (EAMS) is a UK initiative established by the Medicines and Healthcare products Regulatory Agency (MHRA) to provide patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation but address unmet medical needs. 

Horizon scanning is a collaborative and systematic process aimed at identifying new and emerging health technologies, particularly medicines, to ensure the NHS is well-prepared for their introduction, both organisationally and financially. It is carried out separately by the different member nations of the UK - this briefing covers the process followed in England.

The Scottish Medicines Consortium horizon scanning process plays an important role in providing NHS Scotland with intelligence on forthcoming medicines.

The MHRA provides strict guidelines for importing unlicensed medicinal products (also known as "specials") into the UK. These guidelines ensure the safety and quality of unlicensed medicines and aim to meet the specific needs of individual patients when no suitable licensed options are available.

Individual Funding Requests (IFRs) are mechanisms within the UK's National Health Service (NHS) that allow for the consideration of funding treatments not routinely commissioned. These requests are typically made when a patient has unique clinical circumstances that may warrant access to a treatment outside standard protocols.

The Innovative Licensing and Access Pathway was launched in January 2021 by the MHRA to speed up the development and delivery of innovative medicines, and it is due to be relaunched in March 2025. It provides a collaborative framework among the MHRA, the national HTA bodies of the UK and, in the revised ILAP, the National Health Service (NHS). The scheme is designed to streamline access to new therapies that meet unmet medical needs, ensuring transformative treatments reach patients more swiftly.

The Innovative Medicines Fund (IMF) is a funding initiative established in England to provide patients with early access to promising new non-cancer medicines that are not yet routinely available through the National Health Service (NHS).

Managed access agreements are time-limited agreements implemented by the National Institute for Health and Care Excellence (NICE) to provide patients with early access to promising but uncertain treatments.

The MHRA's 150-day assessment process is an expedited pathway for evaluating national marketing authorisation applications for medicines. This streamlined process aims to accelerate patient access to safe and effective medicines by reducing the standard assessment timeline while maintaining rigorous regulatory standards.

The MHRA's international recognition procedure enables medicines that have been approved by trusted regulatory authorities — such as the European Medicines Agency (EMA) or the U.S. Food and Drug Administration (FDA) — to receive authorisation in the UK through a streamlined process that acknowledges these prior assessments.

The Medicines and Healthcare products Regulatory Agency (MHRA) offers a comprehensive service for pharmaceutical companies seeking scientific advice during the development of their products. This guidance is intended to help companies optimise their development process and ensure compliance with regulatory requirements.

The National Institute for Health and Care Excellence (NICE) offers a comprehensive advisory service aimed at helping pharmaceutical and health technology companies enter the NHS market. This service supports companies in generating evidence, refining economic models, and preparing for engagement with NHS payers and commissioners. The goal is to ensure that innovative treatments can be successfully introduced into the healthcare system.

NICE is a UK public body that provides national guidance and advice to improve health and social care. It conducts comprehensive HTAs to evaluate the clinical efficacy and cost-effectiveness of pharmaceuticals, medical devices, and interventions. These evaluations inform reimbursement decisions and clinical guidelines within the NHS England, aiming to optimise resource allocation and ensure evidence-based patient care. Its guidance is also typically also implemented in Wales and Northern Ireland.

The NICE appraisal process follows a detailed timeline that differs according to the type of appraial and the technology concerned. The steps involved in the process and their timing are set out in this article.

The National Institute for health and Care Excellence uses real-world evidence to fill gaps in knowledge and support decision-making in health and social care. This evidence is derived from data collected outside of controlled clinical trials, often referred to as real-world data. NICE has developed a framework to guide the generation and use of this type of evidence, aiming to increase its quality and transparency.

For the submission of medicines in NICE’s Single Technology Appraisal (STA) process, the clinical evidence section is central. Demonstration of the medicine’s effectiveness in relation to its use in the NHS allows NICE to assess the benefits and risks of the technology compared to standard treatment options currently offered. The submission must include robust clinical data, following NICE’s guidelines on the types and quality of evidence.