EMA Terms (24)

Annex 1 is the European Union GMP guideline governing the manufacture of sterile medicinal products, distinguished from other GMP annexes by mandating a facility-wide Contamination Control Strategy and graded cleanroom control, in force since 25 August 2023.

A batch record is the controlled document that both instructs and evidences the manufacture of a single batch of drug product, capturing actual materials, equipment, parameters, yields, deviations, and operator signatures step by step.

Clinical Trial Application (CTA) is the authorisation dossier a sponsor files with a national or EU regulator before dosing the first subject in a trial of an investigational medicinal product, the non-US counterpart to an FDA IND.

A Data Monitoring Committee is an independent group of clinicians and statisticians that reviews unblinded accumulating data during a trial and recommends to the sponsor whether to continue, modify, or terminate it.

Decentralized Clinical Trials are clinical investigations in which some or all participant activities, including consent, dosing, assessments and safety monitoring, happen at the participant's home or a local provider instead of the investigator's research site.

Deviation is a departure from an approved instruction, procedure, specification, or established standard in a regulated process, which GMP requires to be recorded and justified, and investigated whenever it is critical or unexplained.

EMA is the European Union agency that scientifically evaluates medicines submitted through the centralised procedure and monitors their safety, issuing recommendations on which the European Commission bases legally binding EU-wide authorisation decisions.

EU GMP Annex 11 is the EudraLex Volume 4 annex governing computerised systems used in GMP-regulated activities, covering lifecycle risk management, validation, audit trails, access control and periodic evaluation, not only the electronic records and signatures Part 11 addresses.

GMP is the minimum standard for the methods, facilities, and controls used to manufacture a drug, enforced through adulteration: a drug made outside GMP is legally adulterated regardless of whether it passes its release tests.

GxP is the collective term for the good-practice regulations and guidelines that govern how regulated companies generate, document, and retain data across laboratory, clinical, and manufacturing activities.

ICH M7 is the harmonised guideline governing assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals, setting acceptable intake limits that ICH Q3A and Q3B leave undefined for genotoxic impurities.

Marketing Authorization Application (MAA) is the dossier a sponsor files to place a medicine on the European Union market. Unlike a US NDA, it is granted by the European Commission on EMA's scientific recommendation.

Minimum Anticipated Biological Effect Level (MABEL) is the human exposure predicted to produce the lowest biologically observable effect, calculated from pharmacology rather than toxicology, and used by EMA as one of three permitted anchors for a first-in-human starting dose.

Nitrosamine impurities are N-nitroso compounds that form in or contaminate drug substances and drug products; ICH M7(R2) places them in the cohort of concern, so each needs a substance-specific acceptable intake, not the generic 1.5 microgram threshold.

Orphan Drug Designation is an FDA status, not an approval, granted to a drug for a disease affecting fewer than 200,000 people in the United States, carrying seven years of marketing exclusivity if the drug is later approved.

A Pediatric Investigation Plan is the EU development programme for studying a medicine in children, assessed by EMA's Paediatric Committee. Marketing authorisation applications for new medicines must report results from an agreed PIP unless a waiver or deferral applies.

The Periodic Benefit-Risk Evaluation Report (PBRER) is the ICH E2C(R2) periodic safety report for marketed medicines, distinguished from the earlier PSUR format by a formal evaluation of benefit alongside risk to support an explicit benefit-risk conclusion.

Periodic Safety Update Report is a pharmacovigilance document a marketing authorisation holder submits at fixed intervals to re-evaluate an authorised medicine's benefit-risk balance against the safety data accumulated worldwide since the previous report.

Pharmacovigilance is the regulated safety discipline covering detection, assessment, understanding, and prevention of adverse drug reactions, and the reporting obligations that bind sponsors during trials and marketing authorisation holders for as long as a product stays on the market.

Pharmacovigilance System Master File (PSMF) is the detailed description of the pharmacovigilance system a marketing authorisation holder operates for EU-authorised medicines, kept at one registered EU site and produced to competent authorities within seven days of request.

Qualified Person for Pharmacovigilance (QPPV) is the single named individual, resident in the EU/EEA, whom a marketing authorisation holder must have permanently and continuously at its disposal to establish and maintain its EU pharmacovigilance system.

RMP is the EU regulatory document that records a medicinal product's risk management system: the important identified risks, important potential risks, and missing information, plus the pharmacovigilance and risk-minimisation activities that address them.

Signal detection is the pharmacovigilance activity of searching safety data for evidence that a medicine may cause a new adverse reaction, or that a known reaction has changed, before that evidence is confirmed.

Signal management is the pharmacovigilance process that carries a suspected safety issue from detection through validation, confirmation, prioritisation and assessment to a documented regulatory decision, with every step, date and rationale tracked.