Glossary

This glossary provides clear, consistent definitions of key terms used across ABPI publications, policy positions, consultations, and digital content. It is intended to support shared understanding among members, policymakers, partners, media, and the public.

A

AoMRC

Academy of Medical Royal Colleges

The body that co-ordinates the work of the medical royal colleges and faculties across the UK and Ireland. It works to improve medical standards and the quality of patient care, and provides a collective voice for the medical profession on issues that span multiple specialties.
https://www.aomrc.org.uk/

AAC

Accelerated Access Collaborative

An NHS England body that brings together the health and care system — including NHS, industry, patient groups and NICE — to speed up patient access to proven, innovative medicines and health technologies. The AAC oversees programmes including the Accelerated Access Pathway and the Innovative Medicines Fund.
https://www.england.nhs.uk/aac/

ATW

Advanced Therapies Wales Programme

A Welsh Government-funded programme supporting the development and delivery of advanced therapy medicinal products (ATMPs) including cell, gene and tissue therapies across NHS Wales, with the aim of ensuring patients in Wales can access these innovative treatments.
https://advancedtherapieswales.co.uk/

ADR

Adverse Drug Reaction

A response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility. Adverse reactions may arise from use of the product within or outside the terms of the marketing authorisation or from occupational exposure. Conditions of use outside the marketing authorisation include off-label use, overdose, misuse, abuse and medication errors.

AE

Adverse event

An unfavourable and unintended experience associated with the use of a medical product in a patient, which may or may not be causally related to the medicine.

AWDCC

All Wales Drugs Contracting Committee

The committee responsible for negotiating and managing national contracts for medicines and related products on behalf of NHS Wales, helping to secure value for money and consistent access to medicines across all Welsh health boards.
https://awttc.nhs.wales/about-us1/our-committees/#AWMSG

AWMSG

All Wales Medicines Strategy Group

The national advisory body for Wales that appraises new medicines and recommends whether they should be made available on the NHS in Wales, working alongside the national processes of NICE. AWMSG decisions apply to all NHS Wales health boards.
https://awttc.nhs.wales/about-us1/our-committees/#AWMSG

AWPAG

All Wales Prescribing Advisory Group

An advisory group that provides guidance and recommendations on prescribing policy and medicines management to NHS Wales health boards and the Welsh Government, supporting safe and effective use of medicines across Wales.
https://awttc.nhs.wales/about-us1/our-committees/#AWMSG

AWTTC

All Wales Therapeutics and Toxicology Centre

The national medicines advisory service for Wales, hosted by Cardiff and Vale University Health Board. AWTTC acts as secretariat to AWMSG and provides expert medicines information, medicines optimisation support, and clinical toxicology services to NHS Wales.
https://awttc.nhs.wales/

AHP

Allied Health Professional

A group of distinct health professionals who apply their expertise to prevent disease, diagnose conditions, and rehabilitate patients across a range of specialisms. AHPs include physiotherapists, occupational therapists, radiographers, dietitians, paramedics and speech and language therapists, among others.
https://www.hee.nhs.uk/our-work/allied-health-professions

Alternative technologies

Non-animal models that can be used in research, including cell-based assays, organ-on-a-chip systems and computational models, as alternatives or complements to animal studies.

AMR

Antimicrobial Resistance

The process by which bacteria, viruses, fungi and parasites evolve in ways that make them resistant to the medicines used to treat the infections they cause. AMR is a major global health threat and a priority area for pharmaceutical research and development, as well as for responsible prescribing.
https://www.abpi.org.uk/antimicrobial-resistance/

AI

Artificial Intelligence

The development of computer systems able to perform tasks that would normally require human intelligence, such as recognising patterns, making decisions and understanding language. AI is increasingly used in pharmaceutical research, drug discovery, clinical trials and healthcare delivery.

AMRC

Association of Medical Research Charities

A membership organisation representing the leading medical research charities in the UK. AMRC members collectively fund over £1.7 billion of medical research each year across universities, hospitals and research institutes.
https://www.amrc.org.uk/

ASAR

AWMSG Secretariat Assessment Report

The All Wales Medicines Strategy Group The formal assessment report produced by the AWTTC Secretariat to inform AWMSG decision-making on new medicines for use in NHS Wales. The ASAR summarises the clinical and cost-effectiveness evidence submitted by manufacturers and provides a recommendation to the committee.
https://awttc.nhs.wales/about-us1/our-committees/#AWMSG

B

Biological medicine

A medicine derived or manufactured from a living biological system, such as a living cell or organism. Biological medicines include hormones (e.g. insulin), enzymes, blood factors, antibodies, vaccines and advanced therapies such as cell, gene and tissue therapies. Because they are produced by living cells, they are complex molecules that cannot be exactly replicated which distinguishes them from small molecule medicines.

Biosimilar

A biological medicine which has been shown not to have any clinically meaningful differences from the originator biological medicine in terms of quality, safety and efficacy. Biosimilars can only be marketed after the originator's patent and data exclusivity period has expired.

BDA

British Dental Association

The professional association and trade union for dentists in the UK. The BDA represents dentists working in general practice, community dental services, hospitals, the armed forces and academia, and provides advice, support and guidance on clinical and professional matters.
https://www.bda.org/

BMA

British Medical Association

The professional association and trade union representing doctors and medical students in the UK. The BMA provides support, advice and services to its members, and acts as an independent voice advocating on behalf of the medical profession on health and healthcare policy.
https://www.bma.org.uk/

BNF

British National Formulary

A joint publication of the British Medical Association and the Royal Pharmaceutical Society, providing UK healthcare professionals with authoritative, up-to-date information on prescribing, dispensing and administering medicines. It includes details of indications, doses, side effects, contraindications and costs.
https://bnf.nice.org.uk/

C

CDF

Cancer Drugs Fund

A source of funding that enables patients in England to access promising cancer medicines while additional evidence is collected. Medicines funded through the CDF are managed by NHS England and NICE, with a view to full technology appraisal once further evidence is available.
https://www.england.nhs.uk/cancer/cdf/

CNCI

Category Normalised Citation Impact

Citation rates vary between research fields and with time. Consequently, analyses must take both publication field and year into account. In addition, the type of publication will also influence the citation count. For this reason, only citation counts of papers (as defined below) are used in calculations of citation impact. The standard normalisation factor is the world average of citations per paper for the year and subject category in which the paper was published. This normalisation is referred to as ‘rebasing’ the citation count. A CNCI value of more than 1.0 indicates performance higher than the world average for the relevant publication field, year, and document type.

Cell and Gene Therapy Catapult

An independent innovation and technology organisation committed to the advancement of cell and gene therapies, working to translate scientific discoveries into clinical and commercial success for the benefit of patients.
https://ct.catapult.org.uk/

CMO

Chief Medical Officer

The most senior government adviser on medical and public health matters in each of the four UK nations. The CMO for England advises the UK Government on health policy, provides independent medical advice, and leads the government's response to public health emergencies.
https://www.gov.uk/government/organisations/chief-medical-officer

CPO

Chief Pharmaceutical Officer

The most senior government adviser on pharmacy and medicines use in each UK nation. In England, the CPO provides professional leadership for the pharmacy workforce, advises on medicines policy and patient safety, and works with NHS and government bodies to improve the use of medicines.
https://www.england.nhs.uk/ahp/chief-pharmaceutical-officer/

COPD

Chronic Obstructive Pulmonary Disease

A common, preventable and treatable lung disease characterised by persistent respiratory symptoms and airflow limitation, usually caused by long-term exposure to harmful particles or gases, most commonly tobacco smoke. COPD encompasses conditions including emphysema and chronic bronchitis.

Citation count

The citation count is the number of times that a citation has been recorded for a given publication since it was published. Not all citations are necessarily recorded since not all publications are indexed. The material indexed by Clarivate, however, is estimated to attract about 95% of global citations.

Citation impact

Citations per paper is an index of academic or research impact (as compared with economic or social impact). For a single paper, raw citation impact is the same as its citation count. For a set of papers, it is calculated by dividing the sum of citations by the total number of papers in any given dataset. Impact can be calculated for papers within a specific research field such as clinical neurology, or for a specific institution or group of institutions, or a specific country. Citation count declines in the most recent years of any time period as papers have had less time to accumulate citations.

Clinical cohort

A research programme and/or infrastructure which involves the collection and storage of samples and clinical data derived from individuals with a pre-determined condition, used to study how diseases develop and how patients respond to treatments over time.

CEPP

Clinical Effectiveness Prescribing Programme

A NHS Wales programme that works to optimise the use of medicines by improving the clinical and cost-effectiveness of prescribing across Wales, including through the development of guidance, benchmarking data and supporting implementation of evidence-based practice.
https://awttc.nhs.wales/

CRO-mCTA

Clinical Research Organisation Model Clinical Trial Agreement

A standardised contract template developed to simplify and accelerate the set-up of commercial clinical trials in the UK when a Contract Research Organisation (CRO) is acting on behalf of an industry sponsor. The model agreement is designed to reduce the time spent negotiating contracts between CROs and NHS sites.
https://www.nihr.ac.uk/documents/model-clinical-trial-agreements/11639

Clinical trial

Any interventional investigation in human participants intended to discover or verify the clinical, pharmacological and/or other effects of a medicine

Clinical trial sponsor

The organisation that has overall responsibility for running the clinical trial. This can be different from the organisation that funds the research.

Code of Practice

An ABPI document which sets out the requirements the pharmaceutical industry must comply with and supports companies' commitment to self-regulation. It governs the promotion of medicines to healthcare professionals and the interactions between pharmaceutical companies, healthcare professionals and patient organisations.
https://www.abpi.org.uk/reputation/abpi-2024-code-of-practice/

Collaborative working

Collaborative working is generally between one or more pharmaceutical companies, healthcare organisations and possibly other organisations. It must have, and be able to demonstrate, the pooling of skills, experience and/or resources from all parties involved, with a shared objective of benefiting patients and/or the NHS.

CAA

Commercial Access Agreement

A confidential pricing arrangement agreed between a pharmaceutical company and NHS England (or devolved equivalents) that allows a medicine to be made available to NHS patients at a price considered commercially and clinically acceptable to both parties, often alongside or following a NICE appraisal.

Commercial collaborative studies

Commercial collaborative studies are typically funded, either wholly or in part, by the life sciences industry and sponsored by a combination of industry and non-commercial organisations.

CHC

Community Health Council

Statutory bodies in Wales that represent the interests of the public in the local health service. CHCs monitor and review NHS services, support patients who wish to make a complaint, and act as a voice for communities in NHS planning decisions. They are a unique feature of NHS Wales.
https://www.wales.nhs.uk/ourservices/directory/communityHealthCouncils

CPW

Community Pharmacy Wales

The representative body for NHS community pharmacy contractors in Wales. CPW negotiates with the Welsh Government and NHS Wales on the contractual and professional framework for community pharmacy, and provides support, guidance and representation for its members.
https://cpwales.org.uk/

Company-Sponsored Digital Activity

A digital activity is considered to be company-sponsored if it is owned, paid for and/or controlled by the company. Control means that the company has authority over the final content. A donation (financial or otherwise) to an organisation/site by a marketing authorisation holder does not constitute ownership, provided that the marketing authorisation holder does not control the final content of the site. A company may sponsor a ‘page’ on a website/platform that they do not own (e.g. a social media or micro-blogging site). If the company has control over the content of a sponsored page, it is considered company-sponsored.

CHD

Coronary Heart Disease

A disease in which the coronary arteries, the blood vessels that supply oxygen-rich blood to the heart muscle, become narrowed or blocked, usually by a build-up of fatty deposits (atherosclerosis). CHD is one of the leading causes of death in the UK and a significant area of pharmaceutical research and treatment.

CIOMS

Council for International Organization of Medical Sciences

An international non-governmental organisation established jointly by WHO and UNESCO, providing guidance on biomedical research ethics and international standards for the conduct of clinical trials and pharmacovigilance. CIOMS guidelines are widely referenced in drug safety reporting.
https://cioms.ch/

Chief Pharmaceutical Officer

CPO

D

Data (Use and Access) Bill

A proposed UK Government Bill with implications for health data sharing, aimed at improving access to public data including health records for research and innovation purposes.

Data access policy

Changes to how NHS data is accessed, including the move from a system of data sharing agreements to a system of data access within secure environments, improving governance and patient privacy.

DARS

Data Access Request Service

The service through which researchers and organisations can apply to access NHS health and social care data held by NHS England, for approved research and planning purposes. DARS provides a governed pathway for accessing nationally collected NHS datasets under appropriate data protection safeguards.
https://digital.nhs.uk/services/data-access-request-service-dars

Data asset

A collection of data that has value for research, such as the UK Biobank, NHS electronic health records or disease registries.

Data linkage

The process of connecting different datasets - for example, linking primary care records with hospital data - to enable a more comprehensive analysis of patient journeys, treatment outcomes and population health trends.

DHCW

Digital Health and Care Wales

The national digital health and care organisation in Wales. DHCW is a specialist body within the NHS Wales family tasked with leading, developing, and delivering digital and data services that support the delivery of health and care across Wales.
https://dhcw.nhs.wales/

Disclosure UK

The pharmaceutical industry's publicly accessible database of payments and benefits-in-kind made by pharmaceutical companies to healthcare professionals and healthcare organisations. It operates under the ABPI Code of Practice and is designed to promote transparency about financial relationships between industry and healthcare.
https://www.disclosureuk.org.uk/

E

Efficacy

The ability of a medicine to produce its desired therapeutic effect under controlled conditions, such as in a clinical trial. Efficacy is one of the three core criteria - alongside quality and safety - that must be demonstrated for a medicine to receive a marketing authorisation.

EMA

European Medicines Agency

The European agency responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. The EMA operates a centralised procedure through which a single marketing authorisation can be obtained that is valid across all EU member states.
https://www.ema.europa.eu/en/homepage

EU

European Union

A political and economic union of member states in Europe. The EU plays a significant role in pharmaceutical regulation through the European Medicines Agency (EMA) and in trade and intellectual property policy relevant to the pharmaceutical industry.
https://european-union.europa.eu/index_en

F

FMV

Fair Market Value

The price at which a medicine would be sold between a willing buyer and a willing seller, acting independently, with full knowledge of relevant facts, and without any pressure or coercion. A price that reflects production cost, R&D, distribution, and a reasonable profit that is comparable to similar drugs in the same therapeutic class. FMV may be used to determine reasonable reimbursement levels in publicly funded health systems.

G

Generic

Generic medicine

A pharmaceutical product that contains the same active substance as a branded (originator) medicine that was originally protected by chemical patents. Generic medicines can only enter the market once the originator's patent expires and are typically available at a lower price.

GLH

Genomic Laboratory Hub

One of seven regional centres in England responsible for co-ordinating and delivering the NHS Genomic Medicine Service's testing programme. Each GLH provides specialist genomic laboratory services and supports clinical genomics across its region.
https://www.england.nhs.uk/genomics/nhs-genomic-med-service/

Genomics England

A company wholly owned by the UK Government that analyses sequenced genomes for the NHS and provides genomic data for research. Genomics England operates the 100,000 Genomes Project and works to embed genomics into routine NHS care.
https://www.genomicsengland.co.uk/

GMP

Good Manufacturing Practice

A system of regulations and quality standards ensuring that medicines are consistently produced and controlled to the quality standards appropriate to their intended use. GMP covers all aspects of production — including starting materials, premises, equipment, staff training and quality control — and is a legal requirement for pharmaceutical manufacturers. Compliance is overseen by the MHRA in the UK.
https://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practice

GVP

Good Vigilance Practice

European Medicines Agency guidelines on pharmacovigilance for medicines authorised in the EU and UK. GVP modules set out standards for the monitoring, assessment and reporting of adverse drug reactions, the preparation of safety reports such as PSURs, and the management of risk minimisation activities by marketing authorisation holders.
https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/good-pharmacovigilance-practices

GCSA

Government Chief Scientific Adviser

The UK Government's most senior adviser on science, engineering and technology. The GCSA provides independent scientific advice to the Prime Minister and Cabinet, ensures that government policy is informed by the best available evidence, and oversees the network of departmental Chief Scientific Advisers.
https://www.gov.uk/government/organisations/government-office-for-science

GDP (Economics)

Gross Domestic Product

A measure of the total value of goods and services produced in a country, used to estimate the size of the economy and its growth. GDP is used in pharmaceutical policy contexts to benchmark the UK's investment in medicines and health research relative to other countries.

GVA

Gross Value Added (direct, indirect, and induced)

A measure of the contribution of a specific sector to the overall economy. GVA impacts are split into direct impacts (value produced by the industry itself), indirect impacts (value across the supply chain) and induced impacts (value generated by employee spending).

H

HCRW

Health and Care Research Wales

The network that supports and co-ordinates health and care research across Wales, enabling NHS Wales to participate in clinical trials and ensuring patients in Wales have equitable access to research opportunities.
https://healthandcareresearchwales.org/

HSC

Health and Social Care

A term used across the UK to describe the combined delivery of NHS healthcare services and publicly funded social care. In Northern Ireland, health and social care services are integrated within a single system.
https://www.health-ni.gov.uk/

HSC R&D

Health and Social Care Northern Ireland R&D Division

The division that funds and co-ordinates health and care research across Northern Ireland, supporting the participation of HSC organisations in clinical trials and research studies for the benefit of patients.
https://www.publichealth.hscni.net/

HDRS

Health Data Research Service

A service providing secure access to health data for research and development purposes, enabling researchers to analyse NHS data within a trusted research environment without the data leaving a secure platform.

HIRANI

Health Innovations Research Alliance Northern Ireland

A not-for-profit, collaborative organisation established to strengthen and grow the Life and Health Sciences ecosystem in Northern Ireland. Founded in 2019, HIRANI acts as the cluster organisation and single strategic voice for the region's health and life sciences sector.
https://hirani.org.uk/

HRA

Health Research Authority

The UK body that protects and promotes the interests of patients and the public in health and social care research. The HRA approves research studies carried out in the NHS and social care in England, ensuring they meet ethical and legal standards.
https://www.hra.nhs.uk/

Health Technology

A broad term covering any intervention that may be used to promote health, prevent, diagnose or treat disease, or for rehabilitation or long-term care. This includes medicines, medical devices, diagnostics and procedures. Health technology assessment (HTA) is the process by which such interventions are evaluated for clinical and cost-effectiveness.

HTA

Health Technology Assessment

The systematic evaluation of the properties and effects of a health technology - which may include a medicine, medical device, diagnostic tool or procedure - addressing both its direct intended effects and its indirect and unintended consequences. HTA is used by bodies such as NICE to inform decisions about which treatments the NHS should fund.
https://www.nice.org.uk/

HCO

Healthcare Organisation

An organisation involved in the delivery of healthcare, such as an NHS Trust, GP practice, or patient group. Pharmaceutical companies are required under the ABPI Code of Practice to disclose transfers of value made to HCOs, as well as to individual healthcare professionals, on Disclosure UK.

HCP

Healthcare Professional

A person who is registered and qualified to provide healthcare services, including doctors, nurses, pharmacists, dentists and allied health professionals. Under the ABPI Code of Practice, pharmaceutical companies must ensure that promotional activities are directed only at HCPs who prescribe, supply, administer or recommend the relevant medicines.

HST

Highly Specialised Technologies

A NICE programme that assesses the clinical and cost-effectiveness of medicines and other technologies intended to treat very rare and serious conditions, typically affecting fewer than 500 patients in England. The HST programme uses modified cost-effectiveness criteria to reflect the particular challenges of developing treatments for ultra-rare diseases.
https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-highly-specialised-technologies-guidance

I

In silico

Research and experiments conducted via computer simulation and virtual models rather than a physical laboratory setting. In silico methods are increasingly used in drug discovery and development to predict how candidate medicines will behave in the human body.

In vitro

Research and experiments conducted outside of a living organism, typically in a controlled laboratory environment using cells, tissues or biochemical components in dishes or tubes.

In vivo

Research and experiments conducted inside of a living organism, either human or animal. In vivo studies are used to assess the safety, efficacy and pharmacological properties of medicines in a whole biological system.

ICER

Incremental Cost-Effectiveness Ratio

A summary measure that represents the economic value of a healthcare intervention when compared with an alternative. An ICER is calculated by dividing the difference in total costs (incremental cost) by the difference in the chosen measure of health outcome (incremental effect), and is typically expressed as a cost per QALY gained.

Indication

The disease, symptom, or condition that a medicine is officially approved to treat, prevent, or diagnose, as set out in its marketing authorisation and Summary of Product Characteristics.

ICSR

Individual Case Safety Report

A report documenting details of a single adverse event or adverse drug reaction experienced by a patient, submitted to regulatory authorities or marketing authorisation holders as part of pharmacovigilance obligations. ICSRs are submitted via systems such as the MHRA's Yellow Card scheme.

Industry clinical trials

Clinical trials (also known as commercial contract studies) sponsored and fully funded by the life sciences industry. These trials test new medicines and treatments in human participants and are a major driver of pharmaceutical research activity in the UK.

IMF

Innovative Medicines Fund

A managed access fund established by NHS England to support patient access to promising non-cancer medicines while additional evidence is collected, following a NICE recommendation. The IMF operates alongside the Cancer Drugs Fund.
https://www.england.nhs.uk/medicines-2/innovative-medicines-fund/

Innovative payment model

Any approach affecting the reimbursement or funding of a medicine beyond the routine market-access pathways. Innovative payment models include outcomes-based agreements, spread payments and other arrangements designed to manage uncertainty about a medicine's real-world value.

ICB

Integrated Care Board

A statutory NHS organisation responsible for planning and funding most health services in a local area in England. ICBs were created by the Health and Care Act 2022 and work within Integrated Care Systems alongside local authorities and other partners.
https://www.england.nhs.uk/integratedcare/

ICS

Integrated Care System

A partnership of NHS organisations, local authorities and other bodies responsible for planning and delivering joined-up health and care services in a defined geographical area of England. ICSs were established on a statutory basis by the Health and Care Act 2022 and comprise Integrated Care Boards and Integrated Care Partnerships.
https://www.england.nhs.uk/integratedcare/

ICH

International Council for Harmonisation

An international body that brings together regulatory authorities and pharmaceutical industry representatives from Europe, the USA, Japan and other regions to harmonise scientific and technical guidelines for the development and approval of medicines. ICH guidelines are widely adopted by regulators including the MHRA and EMA.
https://www.ich.org/

J

Joint Working

A specific type of NHS-industry collaborative working project, distinct from the broader term collaborative working. Joint working projects must be patient-centred and always benefit patients directly, requiring formal agreement and transparency under the ABPI Code of Practice.

L

Launch sequence

The order in which a pharmaceutical company chooses to launch a new medicine in different countries. The UK's position in the global launch sequence - i.e. how quickly UK patients can access a new medicine relative to patients in other countries - is influenced by the commercial environment, VPAG payment rates and NICE cost-effectiveness thresholds.
https://www.abpi.org.uk/value-and-access/uk-medicine-pricing/

Licensed medicine

Licensed

A medicine that has received a marketing authorisation from a regulatory body such as the MHRA or EMA, confirming it meets the required standards of quality, safety and efficacy. A licensed medicine may only be used within the conditions specified in its marketing authorisation.

LOWMAG

Licensed One Wales Medicines Assessment Group

A subgroup of AWMSG that assesses medicines which are already licensed and in use in Wales but have not previously undergone formal national appraisal. LOWMAG makes recommendations to AWMSG on whether such medicines should be formally approved for NHS Wales prescribing.
https://awttc.nhs.wales/about-us1/our-committees/#AWMSG

Life sciences

A broad term encompassing the pharmaceutical, biotechnology, medical technology and diagnostics sectors. In the UK policy context life sciences refers to the industries that research, develop and manufacture medicines, vaccines and health technologies, and which make a major contribution to the UK economy.
https://www.gov.uk/government/organisations/office-for-life-sciences

Longitudinal data

Data collected from the same individuals or population over a long period of time, allowing researchers to track changes, identify trends and understand the long-term effects of diseases and treatments.

LOE

Loss of Exclusivity

The point at which a branded medicine's patent protection and/or regulatory data exclusivity expires, allowing other manufacturers to bring generic or biosimilar versions to market. LOE typically leads to significant price competition and reduced revenues for the originator company.

M

Managed access

An approach that allows patients to access medicines while further evidence on their clinical or cost-effectiveness is generated. Managed access arrangements are typically overseen by NICE and NHS England and may involve conditions such as data collection requirements or commercial agreements.

Marketing authorisation

A legally binding licence issued by a regulatory body (e.g. MHRA, EMA) confirming a medicine meets necessary standards of quality, safety and efficacy for sale. No medicine can be legally marketed without this authorisation, which defines the approved indications, doses and conditions of use.

MAH

Marketing Authorisation Holder

The company or organisation that holds the legal licence (marketing authorisation) granted by a regulatory body such as the MHRA or EMA, permitting a medicine to be placed on the market. The MAH bears legal responsibility for the quality, safety and efficacy of the medicine, including post-marketing pharmacovigilance obligations.

Medical Affairs

The part of a pharmaceutical company that engages with healthcare professionals regarding the clinical and scientific aspects of its products. The Medical Affairs function provides accurate, balanced medical information and supports the appropriate use of medicines.

MHRA

Medicines and Healthcare products Regulatory Agency

The UK government agency responsible for ensuring that medicines, medical devices and blood components meet applicable standards of safety, quality and efficacy. The MHRA grants marketing authorisations for new medicines in the UK, oversees post-market safety surveillance, and runs the Yellow Card adverse event reporting scheme.
https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

Medicines Optimisation

A person-centred approach to ensuring the safe and effective use of medicines, focused on achieving the best possible outcomes from medicines for patients. Medicines optimisation considers the patient's experience, evidence-based prescribing and value to the NHS.

MOIC

Medicines Optimisation Innovation Centre

A regional centre of excellence in Northern Ireland that focuses on promoting and supporting the optimal use of medicines in health and social care. Its goal is to improve patient outcomes, enhance medication safety and ensure value for money through innovation and best practice.
https://moic.hscni.net/

Multimorbidity

The presence of two or more long-term health conditions in the same individual. Multimorbidity is increasingly common as the population ages and presents particular challenges for prescribing, medicines management and NHS resource planning.

MRA

Mutual Recognition Agreement

An agreement between two or more regulatory authorities (such as the MHRA and the FDA) to recognise each other's inspections, approvals or standards for medicines manufacturing and regulation. MRAs can reduce duplication of regulatory work and speed up the availability of medicines in multiple markets.
https://www.abpi.org.uk/international-trade-and-ip/

N

National Data Library

A government initiative to bring together existing research programmes and public data assets - including health data - to help deliver data-driven public services and support research and innovation.

NICE

National Institute for Health and Care Excellence

The organisation responsible for providing national guidance and advice to improve health and social care in England. NICE assesses the clinical and cost-effectiveness of new medicines and other health technologies, and its guidance determines whether NHS commissioners are required to fund a treatment.
https://www.nice.org.uk/

NIHR

National Institute for Health and Care Research

The organisation that funds and delivers health and social care research in England, working in partnership with the NHS, universities, local government, other research funders and industry. The NIHR is the largest funder of clinical and applied health research in the UK.
https://www.nihr.ac.uk/

NHS 10 Year Health Plan

The UK Government's long-term plan for reforming the NHS in England to ensure it is fit for the future, addressing challenges including workforce, technology adoption, prevention and the shift from hospital to community-based care.
https://www.gov.uk/

NHS Commissioning Support Units

Independent organisations that provide commissioned services back to NHS England and integrated care boards, including analytical support, procurement, HR and communications services.

NHS England

The organisation that leads the National Health Service in England, overseeing the commissioning of healthcare services, implementing national policy and working with integrated care systems to improve health outcomes.
https://www.england.nhs.uk/

NHS GMS

NHS Genomic Medicine Service

The NHS England service that delivers genomic testing and analysis to patients across England, enabling clinicians to use genomic information to diagnose rare diseases, guide cancer treatment and inform family members of inherited risks. The NHS GMS operates through a network of seven Genomic Laboratory Hubs.
https://www.england.nhs.uk/genomics/nhs-genomic-med-service/

NRS

NHS Research Scotland

The organisation that supports and co-ordinates health research activity across Scotland, enabling NHS Scotland to participate in clinical trials and research studies and ensuring patients in Scotland have access to research opportunities.
https://www.nhsresearchscotland.org.uk/

NICE cost-effectiveness threshold

The range within which NICE judges a new medicine to represent good value for money for the NHS, expressed as a cost per Quality-Adjusted Life Year (QALY) gained. NICE currently applies a threshold of £20,000-£30,000 per QALY for standard technology appraisals. These thresholds have not been substantively revised since 1999.
https://www.nice.org.uk/

NAM

Non-animal model / New approach methodology

Research tools and techniques - including cell-based assays, organ-on-a-chip systems, computational models and human tissue studies - used to study disease and test potential medicines without using animals. NAMs are increasingly used alongside or instead of animal models in pre-clinical research.

Non-commercial studies

Clinical studies sponsored and wholly funded by one or more non-commercial organisations, including medical research charities, universities and public funders such as the NIHR. They differ from industry-sponsored commercial studies in their funding structure and governance.

Non-Company-Sponsored Digital Activity

A digital activity that is not owned, paid for or controlled by a pharmaceutical company. For such a digital activity, there must be no possibility that the pharmaceutical company has been able to exert any influence over or control the final content.

NHP

Non-human primate

A category of non-human mammals used in a small proportion of pharmaceutical research, including species such as macaques. Due to their biological similarity to humans, non-human primates are sometimes used where no other model is considered scientifically sufficient. Their use is subject to strict regulatory controls under the Animals (Scientific Procedures) Act 1986.
https://www.gov.uk/guidance/animals-used-in-science-the-3rs

O

Off-label

Off-label use

The use of a medicine in a way that differs from its licensed indication, dose, route of administration or patient population as described in the Summary of Product Characteristics. Off-label prescribing is legally permitted in certain clinical circumstances but requires particular care and informed consent.

Omics data

Biological data related to genomics (DNA), proteomics (proteins), metabolomics (metabolites) or other molecular-level information. Omics data is increasingly used in pharmaceutical research to understand disease mechanisms and identify potential new drug targets.

Oncology

The branch of medicine dealing with the prevention, diagnosis and treatment of cancer. Oncology accounts for a significant proportion of pharmaceutical research and development activity and the largest share of NICE technology appraisals and Cancer Drugs Fund-funded treatments.

OWMAG

One Wales Medicines Advisory Group

An AWMSG subgroup that provides advice on the use of unlicensed medicines, or licensed medicines used outside their marketing authorisation (off-label), for patients in Wales where no licensed alternative is available and there is an evidenced clinical need.
https://awttc.nhs.wales/about-us1/our-committees/#AWMSG

OpenSAFELY

An NHS England-commissioned software platform for the analysis of electronic health records data, enabling researchers to run analyses against patient data within a secure environment without the data being extracted.
https://opensafely.org/

Orphan drug

Orphan medicine

A medicine developed specifically to treat a rare disease or condition, typically defined as affecting fewer than 5 in 10,000 people in the EU. Orphan medicines receive special regulatory incentives - including market exclusivity and fee reductions - to encourage their development, since the small patient population would otherwise make commercial investment unattractive.
https://www.ema.europa.eu/en/human-regulatory-overview/rare-disease-designations

Outcomes-based agreement

A payment arrangement in which the level of reimbursement paid to a pharmaceutical company is linked to the outcomes achieved by a medicine in real-world use, helping to manage uncertainty about a medicine's effectiveness and share risk between the NHS and industry.

OTC

Over the Counter medicine

A medicine that can be purchased directly from a pharmacy or other retail outlet without a prescription from a doctor. OTC medicines are considered safe and appropriate for self-treatment of minor conditions when used as directed.

Overprescribing

The prescribing of a medicine where the potential harm outweighs the likely benefit for an individual patient, or where no medicine is needed. Overprescribing is one aspect of inappropriate prescribing and a focus of NHS medicines optimisation efforts.

P

Papers

A subset of publications consisting of ‘articles’ and ‘reviews’ only. Articles are reports of original research published in a peer-reviewed journal and/or presented at a symposium. Reviews are renewed studies of previous research, such as literature reviews and meta-analyses. Papers are the primary means of scholarly communication and considered the most informative for citation analysis. All citation-related results in this report (except patent citations) are therefore based on papers only.

Papers

Papers (research)

A subset of research publications consisting of articles and reviews only. Papers are the primary means of scholarly communication and are considered the most informative document type for citation analysis.

Patent

An exclusive legal right granted for a new invention, such as a medicine, allowing the owner to prevent others from making, using or selling the invention for a limited period (typically 20 years from the date of filing). Patents are a key mechanism for incentivising pharmaceutical R&D investment.
https://www.abpi.org.uk/international-trade-and-ip/intellectual-property-ip/

Pathophysiology

The physiological processes associated with a disease - i.e. how a disease disrupts normal biological functioning. Understanding pathophysiology is fundamental to identifying drug targets and developing effective medicines.

Patient access scheme

An arrangement agreed between a pharmaceutical company and NHS England (or equivalent devolved body) to make a medicine available at a price or under conditions that allow it to be considered cost-effective and recommended for NHS use. A patient access scheme may involve a simple discount or a more complex outcomes-based arrangement.

PPI

Patient and Public Involvement

The active partnership of patients, carers and members of the public in the design, delivery, evaluation and governance of healthcare services and research — not as participants, but as contributors and decision-makers.

PPIE

Patient and Public Involvement and Engagement

A wider term than Patient and Public Involvement, which also encompasses engaging and communicating more broadly about research with patients and the public, including raising awareness, sharing findings and building public trust in research.

PSUR

Periodic Safety Update Report

A safety report that marketing authorisation holders are required to submit periodically to regulatory authorities, providing a comprehensive review of the global safety data for a medicine, including new adverse event reports, risk-benefit assessment and any new safety findings since the previous report.

Pharmacogenomics

The study of how an individual's genetic make-up affects their response to medicines. Pharmacogenomic testing can help clinicians predict which patients are likely to benefit from - or experience adverse effects from - a particular treatment, supporting more personalised prescribing decisions.

PV

Pharmacovigilance

The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problems. Pharmaceutical companies are legally required to operate pharmacovigilance systems and to report safety data to regulatory authorities.
https://www.abpi.org.uk/r-d-manufacturing/pharmacovigilance-drug-safety/

PMMT

Pharmacy and Medicines Management Team

Part of Northern Ireland's Health and Social Care system, operating within the Strategic Planning and Performance Group (SPPG). The PMMT is responsible for clinical governance, quality assurance, service development and medicines optimisation across community pharmacy and medicines management services.

Polypharmacy

The concurrent use of multiple medicines by a single patient, typically defined as five or more medicines. Polypharmacy can be appropriate (when all medicines are clinically indicated) or problematic (when medicines interact harmfully or when some are no longer needed).

Post-marketing surveillance

The ongoing monitoring of the safety, quality and effectiveness of a medicine after it has received marketing authorisation and is in routine clinical use. Post-marketing surveillance includes spontaneous adverse event reporting (e.g. via the Yellow Card scheme), pharmacoepidemiological studies and periodic safety update reports.

Pre-clinical model

Laboratory-based, computer-based or animal-based research tools designed to mimic human biology as closely as possible, used to understand human biology and test potential therapeutic candidates before clinical trials in humans begin.

Pre-clinical research

All medical research that occurs prior to clinical trials in humans. This includes basic research, drug discovery, translational research and pre-clinical studies, and is used to establish that a potential medicine is sufficiently safe and promising to proceed to human testing.

PMCPA

Prescription Medicine Code of Practice Authority

The independent body responsible for administering the ABPI Code of Practice for the Pharmaceutical Industry. The PMCPA considers complaints about alleged breaches of the Code and publishes its rulings transparently.
https://www.pmcpa.org.uk/

POM

Prescription Only Medicine

A medicine that can only be supplied to a patient on the prescription of an authorised prescriber, such as a doctor, dentist or nurse prescriber. POM status is granted where a medicine requires professional oversight due to its clinical complexity, potential side effects or risk of misuse.

PC

Product Complaint

A customer's written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a medicine after it is released for distribution.

PPP

Public-private partnership

A collaboration between government bodies or the NHS and private companies for the joint delivery of services, infrastructure or research programmes. Public-private partnerships in health and life sciences can accelerate access to innovation while sharing investment and risk.

Publications

A collection of research outputs regardless of document type, as indexed in the Web of Science. In addition to articles and reviews, publications can cover a wide range of document types such as books, conference proceedings, editorial material, bibliographies, meeting abstracts, etc. While these are all relevant forms of scholarly communication, only articles and reviews (that is, papers) are considered in citation analyses.

Q

QPPV

Qualified Person for Pharmacovigilance

A named individual, required by EU and UK medicines law, who is responsible for the establishment and maintenance of a pharmaceutical company's pharmacovigilance system. The QPPV must be based in the UK (or EU for EMA-authorised products) and acts as the single point of contact with regulatory authorities on pharmacovigilance matters.

QALY

Quality-adjusted life year

A health economics measure combining the length and quality of life into a single unit, used to evaluate the benefit of healthcare interventions. One QALY is equal to one year of life in perfect health. QALYs are used by NICE to assess the cost-effectiveness of medicines and inform NHS funding decisions.

R

Rare disease

A condition that affects a small number of people relative to the general population. In the EU and UK, a disease is generally classified as rare if it affects fewer than 5 in 10,000 people. Despite each individually affecting small numbers of patients, there are estimated to be over 7,000 rare diseases, collectively affecting around 3 million people in the UK.
https://www.abpi.org.uk/rare-diseases/

Real world evidence

Clinical evidence about the usage and potential benefits or risks of a medicine derived from the analysis of data generated during routine clinical practice, rather than from controlled clinical trials. Real world evidence is increasingly used to inform regulatory decisions, NICE appraisals and NHS commissioning.

Regional SDE

Regional Secure Data Environment

A secure data environment providing approved researchers with access to health data at a regional level, enabling analysis of locally held NHS datasets within a governed and protected platform.

Regulatory science

The science of developing new tools, standards and approaches to evaluate the efficacy, safety, quality and performance of medical products, in order to assess benefit-risk and facilitate sound, transparent regulatory decision-making. Regulatory science underpins the work of bodies such as the MHRA and EMA.
https://www.abpi.org.uk/r-d-manufacturing/regulation-and-regulatory-science/

R&D

Research and Development

The combined activities of discovering new medicines (research) and developing them through pre-clinical and clinical testing into treatments that can be approved for patient use (development). Pharmaceutical R&D is a lengthy, high-risk and capital-intensive process that typically takes over a decade before a medicine reaches patients.

Resected tissue

A small piece of tissue surgically removed from a patient, typically for diagnostic or research purposes. Resected tissue samples are used in pre-clinical research and biomarker studies to better understand disease biology.

RMP

Risk Management Plan

A document submitted by pharmaceutical companies as part of the marketing authorisation process, detailing how the known and potential risks of a medicine will be prevented, minimised or monitored in patients.

S

SI

Safety Information

Information relating to the safety of a medicine, including adverse events, use during pregnancy, exposure during breast-feeding, overdose, drug abuse or misuse, medication errors, unapproved or off-label use, drug-drug or drug-food interactions, suspected transmission of an infectious agent, and occupational exposure.

SMC

Scottish Medicines Consortium

The body responsible for assessing the clinical and cost-effectiveness of newly licensed medicines for use within NHS Scotland. A successful SMC submission is necessary for medicines to be routinely available to Scottish patients on the NHS.
https://www.scottishmedicines.org.uk/

Severity modifier

A NICE appraisal mechanism that gives greater weight to treatments for conditions that are particularly severe, increasing the likelihood of a medicine being judged cost-effective and recommended for NHS use. The severity modifier reflects the additional value society places on treating the most serious illnesses.
https://www.nice.org.uk/

Siloed data

Data stored in separate systems or organisational units without easy connectivity or interoperability across those systems. In health research, siloed data limits the ability to link datasets and generate comprehensive insights from NHS patient records.

Small molecule medicine

A medicine made by combining defined chemicals in a series of chemical reactions, resulting in a relatively simple and stable molecular structure. Small molecule medicines are typically taken orally and can usually be replicated as generic medicines once patent protection expires.

Specialised Commissioning

The process of planning, securing and monitoring specialised health services for patients with rare, complex or high-cost conditions, such as cancer, genetic disorders and specialised mental health needs. Specialised commissioning is managed at a national level by NHS England.
https://www.england.nhs.uk/commissioning/spec-services/

Spread payments

A payment approach in which the cost of a medicine - often a high-cost, one-time treatment such as a gene therapy - is divided into instalments over time rather than paid as a single upfront sum, helping to manage the NHS budget impact of expensive innovative treatments.

Statutory scheme

The government-regulated alternative to the voluntary VPAG scheme for branded medicines pricing in the UK. Companies that do not join the Voluntary Scheme are subject to the Statutory Scheme, regulated by the Medicines (Control of Prices and Supply of Information) Regulations.
https://www.abpi.org.uk/value-and-access/uk-medicine-pricing/

SPPG

Strategic Planning and Performance Group

A directorate within Northern Ireland's Department of Health that oversees how health and social care services are planned, commissioned and managed across the Health and Social Care system.

SmPC

Summary of Product Characteristics

The legally approved document that forms the basis of information for healthcare professionals on how to use a medicine safely and effectively. The SmPC describes the medicine's indications, dosage, contraindications, warnings, drug interactions, side effects and pharmacological properties. It is prepared by the manufacturer and approved as part of the marketing authorisation process.

T

Therapeutic class

A way of grouping medicines according to their mechanism of action or the condition they are used to treat. Therapeutic class comparisons are used in prescribing guidance and medicines optimisation.

Translational research

Research that bridges the gap between basic laboratory science and clinical application in patients - often described as taking discoveries from bench to bedside. Translational research encompasses the studies that test whether laboratory or pre-clinical findings have potential as treatments for human patients.

TRE

Trusted Research Environment

A secure environment that allows sensitive health data to be accessed and analysed by approved researchers without the data leaving the platform. TREs - also referred to as Secure Data Environments or Data Safe Havens- are a key component of the UK's approach to safe and proportionate health data access.

U

UK Biobank

A major biomedical database and research resource, established as a charity in 2006, containing in-depth genetic and health data from approximately 500,000 UK participants. UK Biobank data is made available to approved researchers globally and is widely used in studies of disease risk, treatment outcomes and population health.
https://www.ukbiobank.ac.uk/

GDPR

UK General Data Protection Regulation

The data protection legislation governing the collection, storage, use and sharing of personal data in the UK. Following the UK's departure from the EU, this is referred to as the UK GDPR and is enforced by the Information Commissioner's Office (ICO). It has significant implications for the use of patient data in pharmaceutical research and pharmacovigilance.
https://ico.org.uk/for-organisations/uk-gdpr-guidance-and-resources/

Underprescribing

The failure to prescribe a medicine that would likely be of clinical benefit to a patient. Underprescribing can result from a range of factors including concerns about side effects, polypharmacy, cost or patient preference, and is considered alongside overprescribing as part of appropriate prescribing practice.

User-centred design

A design process that prioritises the needs, experiences and feedback of end users throughout the development of a product or service. In health data and digital health contexts, user-centred design ensures that systems are built around the needs of patients, clinicians and researchers.

V

Variation

A change to the terms of a marketing authorisation for a medicine. Variations may relate to changes in the indication, dosage, manufacturing process, labelling or safety information, and must be approved by the relevant regulatory authority.

Vascularisation

The process through which blood vessels develop in tissues and organs. In pharmaceutical and pre-clinical research, vascularisation is relevant to the development of tissue-engineered products and organ-on-a-chip models used as pre-clinical tools.

VPAG

Voluntary Scheme for Branded Medicines Pricing Access and Growth

The current (2024-2028) voluntary agreement between the UK Government (DHSC), NHS England and the ABPI governing the pricing of branded medicines sold to the NHS. Under the VPAG, companies pay a rebate on NHS sales of branded medicines, with different rates applying to new active substances, newer medicines and older medicines.
https://www.abpi.org.uk/value-and-access/uk-medicine-pricing/voluntary-scheme-on-branded-medicines/

W

Web of Science subject categories

Journals are assigned to one or more categories, and every article within that journal is subsequently assigned to that category. Journals in the Web of Science Core Collection can be assigned to up to six categories, which are selected on the basis of a range of criteria including journal subject matter and scope, author and editorial board affiliations, funding agencies providing grant support, cited references as well as citing and cited reference relationships, journal sponsors, and categorisations in other bibliographic databases. The selection procedures for the journals included in the citation databases as well as the scope of each subject category are documented here: http://mjl.clarivate.com/.
https://mjl.clarivate.com/

WIPO

World Intellectual Property Organization

A specialised agency of the United Nations created to protect and promote intellectual property internationally. Through WIPO countries can shape IP rules that set the terms of business for sectors like the pharmaceutical industry.
https://www.who.int/

WTO

World Trade Organization

A multilateral institution which regulates and sets the terms for global trade and international rules for business, including through agreements such as TRIPS which govern pharmaceutical intellectual property rights.
https://www.wto.org/

Y

Yellow Card

Yellow Card Scheme

The MHRA's system for collecting reports of suspected adverse drug reactions and incidents involving medicines, vaccines, medical devices and other healthcare products. Healthcare professionals, patients and members of the public can submit Yellow Card reports, which are used to monitor the safety of products in routine clinical use.
https://yellowcard.mhra.gov.uk/