Glossary of regulatory terms

EMA's glossary of regulatory terms gives definitions for the main regulatory terms used on this website and in EMA documents.

EMA has developed the definitions in this glossary to help this website's users understand regulatory terminology. Definitions may differ from those given in European Union legislation.

You can search within this glossary or click on a letter below to see terms beginning with that letter.

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• Accelerated assessment

• Access to documents

• Active substance

• Active substance master file

• Adjuvant

• Advanced therapy medicinal product

• Adverse drug reaction

• Adverse event

• Ancillary human blood derivative

• Ancillary medicinal substance

• Annual re-assessment

• Article 58 application

• ATC code

• Bioavailability

• Bioequivalence

• Biomarker

• Biomarker qualification

• Biosimilar medicine

• Biotechnology

• CAT

• Centralised procedure

• Centrally authorised product

• CHMP

• Class waiver

• Clinical trial

• Clock stop

• CMDh

• CMDv

• Co-rapporteur

• Commercially confidential information

• Committee for Advanced Therapies

• Committee for Medicinal Products for Human Use

• Committee for Orphan Medicinal Products

• Committee for Proprietary Medicinal Products

• Committee for Veterinary Medicinal Products

• Committee on Herbal Medicinal Products

• Common technical document

• COMP

• Compassionate use

• Competent authority

• Concept paper

• Concerned Member State

• Conditional marketing authorisation

• Coordination Group for Mutual Recognition and Decentralised Procedures - Human

• Coordination group for mutual recognition and decentralised procedures for veterinary medicinal products

• Counterfeit medicine

• CVMP

• Data exclusivity

• Decentralised procedure

• Declaration of interests

• Deferral (paediatric)

• Direct healthcare-professional communication

• Electronic common technical document

• Environmental risk assessment

• EudraCT

• EudraNet

• EudraPharm

• EudraVigilance

• EURD list

• European Commission decision

• European medicines regulatory network

• European Network of Centres for Pharmacoepidemiology and Pharmacovigilance

• European Network of Paediatric Research at the European Medicines Agency

• European Pharmacopoeia

• European public assessment report

• European Review System

• European Union Clinical Trials Register

• European Union herbal monograph

• Exceptional circumstances

• Excipient

• Falsified medicine

• Gene-therapy medicine

• Generic medicine

• Good agricultural and collection practice

• Good clinical practice

• Good distribution practice

• Good laboratory practice

• Good manufacturing practice

• Good pharmacovigilance practices

• Grouping

• Guideline

• Heads of Medicines Agencies

• Health technology assessment body

• Herbal medicinal product

• Herbal preparations

• Herbal substances

• HMPC

• Hybrid medicine

• ICH

• Indication

• Individual case safety report

• Informed consent application

• Innovative medicine

• International birth date

• International non-proprietary name

• Invented name

• Investigational medicinal product

• Labelling

• List of outstanding issues

• List of questions

• Market exclusivity

• Market protection

• Marketing authorisation

• Marketing authorisation application

• Marketing authorisation holder

• Master data

• Maximum residue limit

• Medicinal product

• Minor use/minor species

• Mock-up

• Mock-up vaccine

• Modelling and simulation

• Mutual recognition

• Mutual recognition agreement

• Nanotechnology

• National competent authority

• Nationally authorised product

• Note for guidance

• Notified body

• Off-label use

• Official Journal of the European Union

• Official medicines control laboratory

• Oral explanation

• Orphan designation

• Package leaflet

• Paediatric Committee

• Paediatric investigation plan

• Paediatric-use marketing authorisation

• Parallel distribution

• Patent

• PDCO

• Periodic safety update report

• Personalised medicine

• Pharmaceutical form

• Pharmacogenomics

• Pharmacovigilance

• Pharmacovigilance Risk Assessment Committee

• Phase-I study

• Phase-II study

• Phase-III study

• Phase-IV study

• Plasma master file

• PRAC

• Product information

• Product-specific waiver

• Protocol assistance

• Rapporteur

• Re-examination

• Reference Member State

• Referral

• Reflection paper

• Regulatory authority

• Renewal

• Request for supplementary information

• Risk management plan

• Risk management system

• Risk minimisation activity

• Route of administration

• Safety signal

• Scientific advice

• Scientific advisory group

• Serious adverse reaction

• Somatic cell based medicine

• Specific obligations

• Specimen

• Subgroup analysis

• Summary of opinion

• Summary of product characteristics

• Sunset clause

• Supplementary protection certificate

• Third country

• Tissue-engineered product

• Transfer of marketing authorisation

• Trial protocol

• Type IA variation

• Type IB variation

• Type II variation

• Urgent safety restriction

• Variation

• Well-established use

• Withdrawal period

• Working party

• Worksharing

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