The science behind – making sense of healthcare acronyms

Jo Share • 3 min read

Having worked with pharma and med devices clients for more than 30 years now, the OSP team is used to participating in key conversations about healthcare — so are well-versed when it comes to the sector-specific jargon used daily.

This handy guide explains the most commonly-used and important acronyms that you’re likely to come across — ensuring you feel like you’re able to speak the same language.

SmPC – Summary of Product Characteristics

An SmPC is a critical legal document required in all marketing authorisation applications in the EU. It provides essential information on how to use a medicine safely and effectively and must be regularly updated whenever new safety or efficacy data emerges.

PI - Prescribing Information

The PI accompanies prescription medications and provides detailed information about the drug, including how it works and potential side effects. It's a key resource for patients seeking to better understand their treatments.

AE – Adverse Event

An AE refers to any unintended or harmful side effect that occurs during treatment. All AEs must be reported to health authorities, often through systems like the MHRA's Yellow Card scheme in the UK.

SAE – Severe Adverse Effect

A SAE includes any AE that results in death, hospitalisation, or significant harm. These must be reported to regulatory authorities within strict timelines (e.g. within 5 days for critical cases).

OTC – Over The Counter

Over-the-counter medications can be purchased without a prescription. These drugs have different regulations compared to prescription-only medications and are commonly used for self-care.

HCP – Health Care Provider

An HCP is a doctor, nurse or other healthcare professional such as pharmacists or paramedics. In the EU and UK, pharma marketing primarily targets HCPs, as direct marketing to patients for prescription drugs is not allowed.

KOL -  Key Opinion Leader

As an acronym, KOL stands for Key Opinion Leader. It’s a term used in healthcare to describe experts and individuals who have a high-profile presence in their field and are respected for their knowledge. They are often sought after for their insights and are influential on social media and at professional events.

MSL – Medical Science Liaison

Medical Science Liaisons (MSLs) work within pharmaceutical and medical device companies to bridge research and marketing by sharing scientific information with HCPs. They play a crucial role in educating healthcare professionals about new drugs and treatments.

ABPI  – Association of the British Pharmaceutical Industry

The ABPI represents pharmaceutical companies in the UK, working on issues such as research, development and marketing of medicines.

EMA - European Medicines Agency 

The European Medicines Agency is a specialised agency of the European Union, located in Amsterdam. It serves as one of two agencies within its organisation which reviews and assesses human drugs developed by pharmaceutical companies for safety and effectiveness. The EMA also regulates human medical devices. The EMA’s role is to ensure that products are safe and effective, that people are adequately informed when they buy medicines, and that medicines are made available at a fair price in all EU member states.

GMC – General Medical Council

The General Medical Council is a public body that maintains the official register of medical practitioners and is an independent regulator for doctors in the UK. The GMC sets standards for students and doctors to improve medical education and practice in the UK, which in turn helps to protect patients.

NICE - National Institute for Health and Care Excellence

NICE provides national guidance on health and social care in England and Wales, including best practices for treatments, public health advice and assessments of new technologies.

PUMA – Paediatric Use Marketing Authorisation

PUMA is a marketing authorisation specifically  covering the indication and appropriate formulation for paediatric use of already authorised medicines,  aiming to ensure safe, effective, and ethically researched medications for paediatric use without unnecessary clinical trials.