Life Sciences Regulatory Glossary

Abbreviated New Drug Application

The FDA pathway for generic medicines. Instead of repeating clinical efficacy trials, the applicant demonstrates that the generic is pharmaceutically equivalent and bioequivalent to an approved reference product, alongside a full quality and manufacturing dossier.

The formal decision that a manufactured batch may be supplied. It follows review of the batch record, deviations, and test results, and in the EU requires certification by a Qualified Person against GMP and the marketing authorisation.

Corrective And Preventive Action

The quality process for investigating a problem, correcting it, addressing its root cause so it does not recur, and preventing similar issues elsewhere. Effectiveness checks close the loop, and CAPA records are a standard focus of inspections and audits.

The manufacturer's declaration that a product complies with the applicable EU legislation and may be placed on the European market. For medical devices and IVDs it follows a conformity assessment, usually involving a notified body outside the lowest risk classes.

Clinical Evaluation Report

The MDR deliverable that documents the systematic appraisal of clinical data for a medical device. It weighs literature, clinical investigations, and post-market data against the intended purpose to confirm safety, performance, and an acceptable benefit-risk profile.

The formal system for proposing, assessing, approving, implementing, and documenting changes to facilities, equipment, materials, processes, or documentation, including the regulatory impact assessment that determines whether a variation must be filed.

Commissioning, Qualification and Validation

The staged programme that brings facilities, utilities, equipment, and processes into GMP service: commissioning of the installation, qualification against design and operating requirements, and validation that the process reliably delivers the required quality.

Computer System Validation

Documented evidence that a computerised system used in a GxP process consistently does what it is specified to do. It covers requirements, risk assessment, supplier assessment, testing, data integrity, and controls under EU GMP Annex 11 and 21 CFR Part 11.

Clinical Trial Application

The application seeking authorisation to run a clinical trial in a given territory. It bundles the protocol, investigator's brochure, IMP dossier, informed consent documents, and site and investigator information for regulatory and ethics review.

Clinical Trials Information System

The single EU portal and database for clinical trial applications under CTR 536/2014. Sponsors submit one dossier for all concerned member states and manage the full lifecycle there: authorisation, substantial modifications, safety reporting, and results.

EU Clinical Trials Regulation

The regulation harmonising clinical trial authorisation and supervision across the EU. It introduced a single submission through CTIS, coordinated assessment between member states, defined assessment timelines, and public transparency of trial information.

For regulated devices, the set of design and process controls protecting confidentiality, integrity, and availability, as described in MDCG 2019-16. It spans secure design, threat modelling, vulnerability handling, and security updates over the supported lifetime.

A departure from an approved procedure, specification, or standard during a GMP activity. Each deviation is documented, classified by impact, investigated for root cause, and assessed for product quality impact before batch disposition.

The European regulation on artificial intelligence, applying a risk-based framework. AI-enabled medical devices and IVDs generally fall in the high-risk category, adding requirements on data governance, transparency, human oversight, robustness, and post-market monitoring on top of MDR or IVDR.

Regulation (EU) 2017/745 on medical devices

The European regulation governing the design, manufacture, and placing on the market of medical devices. It replaced the Medical Device Directive and tightened clinical evidence, technical documentation, traceability, and post-market surveillance requirements for all device classes.

European Database on Medical Devices

The European Commission database supporting MDR and IVDR. Its modules cover actor registration, UDI and device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance, and market surveillance.

Extractables are compounds that can be drawn out of a container, device, or manufacturing material under exaggerated conditions; leachables are those that actually migrate into the product in normal use. Both are studied to support patient safety assessments.

Good Clinical Practice

The international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human subjects, set out in ICH E6. Compliance protects participant rights and safety and makes trial data credible to regulators.

Good Distribution Practice

The quality standard for the storage, transport, and distribution of medicinal products. It covers wholesale licensing, qualified personnel, temperature control and mapping, supplier and customer qualification, and the handling of returns and falsified medicines.

Good Laboratory Practice

The quality system governing how non-clinical safety studies are planned, performed, recorded, reported, and archived, so that regulators can rely on the data submitted in a marketing application.

Good Manufacturing Practice

The set of rules ensuring medicinal products are consistently produced and controlled to the quality standards required by their intended use and marketing authorisation. In Europe it is set out in EudraLex Volume 4; in the US in 21 CFR Parts 210 and 211.

Good Pharmacovigilance Practices

The EMA modules setting out how marketing authorisation holders and authorities must run pharmacovigilance: quality systems, the pharmacovigilance system master file, risk management, signal management, safety reporting, and post-authorisation safety studies.

The ICH guideline on residual solvents in pharmaceuticals. It classifies solvents by toxicity, sets permitted daily exposures and concentration limits, and underpins the analytical control strategy, typically by gas chromatography.

The standard defining the software development lifecycle for medical device software: safety classification A to C, planning, requirements, architecture, verification, configuration management, problem resolution, and maintenance after release.

The documented process by which a participant voluntarily confirms willingness to take part in a trial, after being informed of its purpose, procedures, risks, benefits, and their right to withdraw at any time without penalty.

The state of being able to host a regulatory inspection at short notice: current documentation, traceable records, trained staff, closed CAPAs, and a rehearsed front-room and back-room process for handling requests during the inspection.

The compilation of clinical and non-clinical data on an investigational product that is relevant to its study in humans. It gives investigators the dosing, safety, and monitoring information they need and is updated as new data emerge.

The international standard for quality management systems specific to medical devices. Certification is the practical route to demonstrating the QMS requirements of MDR Article 10 and IVDR Article 10, and is expected by most notified bodies and customers.

The standard for applying risk management to medical devices across the lifecycle: risk analysis, evaluation, control, evaluation of overall residual risk, and production and post-production information feeding back into the risk file.

Regulation (EU) 2017/746 on in vitro diagnostic medical devices

The European regulation for in vitro diagnostic medical devices. It introduced a risk-based classification (A to D), moved most IVDs under notified body oversight, and requires performance evaluation covering scientific validity, analytical performance, and clinical performance.

The ongoing regulatory maintenance of an authorised product: variations, renewals, labelling updates, new indications, site or supplier changes, and responses to authority requests, all managed so the authorisation stays valid and current.

Marketing Authorisation Application

The dossier submitted to EMA or a national authority requesting permission to market a medicinal product in Europe. It compiles quality, non-clinical, and clinical data in the Common Technical Document format, together with labelling and risk management documentation.

Manufacturing and Importation Authorisation

The licence a national competent authority grants for manufacturing, importing, or batch-releasing medicinal products in the EU. It names the authorised sites, activities, dosage forms, and the Qualified Persons attached to the licence.

New Drug Application

The application through which a sponsor asks the FDA to approve a new medicinal product for the United States market. It presents the full development package: chemistry and manufacturing, non-clinical safety, clinical efficacy and safety, and proposed labelling.

An independent organisation designated by an EU member state to assess whether medical devices and IVDs meet regulatory requirements before CE marking. Its conformity assessment covers the quality management system, technical documentation, and ongoing surveillance audits.

Post-Market Clinical Follow-up

The proactive collection and evaluation of clinical data from a CE-marked device in normal use, planned to confirm safety and performance, keep the benefit-risk determination current, and detect emerging risks or off-label use.

Post-Market Surveillance

The systematic collection and review of experience gained from devices or medicines already on the market, feeding complaint handling, vigilance reporting, risk management, and the periodic safety update report or PSUR equivalent for devices.

Periodic Safety Update Report

The periodic report in which a marketing authorisation holder re-evaluates the benefit-risk balance of an authorised medicine using cumulative safety data, exposure estimates, and signal evaluations over the reporting interval.

Quality Management System

The documented set of processes, responsibilities, and records through which an organisation plans, controls, and improves product quality and regulatory compliance, from design and supplier control through production, release, complaints, and CAPA.

Qualified Person for Pharmacovigilance

The individual a marketing authorisation holder must appoint in the EU to establish and maintain the pharmacovigilance system. The QPPV has oversight of the safety profile of all authorised products and is the authorities' round-the-clock point of contact.

The named individual legally responsible under EU law for certifying that each batch of a medicinal product was manufactured and tested in line with GMP and the marketing authorisation before it is released to the market.

The document describing what is known and unknown about a medicine's safety, the measures planned to characterise and minimise its risks, and how the effectiveness of those measures will be measured over the product's lifecycle.

Software as a Medical Device

Software intended for a medical purpose that performs that purpose on its own, without being part of a hardware device. Under MDR and IVDR it is qualified and classified in its own right, with clinical evidence, usability, and cybersecurity requirements.

A formal consultation in which a developer asks a regulator, such as EMA or a national agency, for guidance on its development plan. Advice typically covers quality, non-clinical, and clinical strategy and reduces the risk of objections later in the procedure.

The activity of identifying new or changed safety information from spontaneous reports, literature, studies, and other sources, then validating and prioritising it to decide whether the product's risk profile or labelling needs to change.

A study following ICH conditions that measures how a product's quality attributes change over time under defined temperature and humidity, establishing the retest period or shelf life and the recommended storage conditions.

Suspected Unexpected Serious Adverse Reaction

A serious adverse reaction in a clinical trial that is suspected to relate to the investigational product and whose nature or severity is not consistent with the reference safety information. SUSARs are subject to expedited reporting to authorities and ethics committees.

The structured evidence file a device or IVD manufacturer maintains to demonstrate conformity, as set out in MDR/IVDR Annexes II and III. It covers device description, design and manufacturing information, risk management, verification and validation, clinical evidence, and post-market data.

Unique Device Identification

A globally unique code carried on device labels and packaging so that a product can be identified and traced through distribution and use. It combines a device identifier for the model with a production identifier for batch, serial number, or expiry.