Glossary - Regulatory terms | European Medicines Agency (EMA)

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