Glossary of Terms


AEMPSSpanish Agency of Medicines and Medical Devices

AIFAItalian Medicines Agency

ANDA – Abbreviated New Drug Application (US)

ANSMFrench National Agency for Medicines and Health Products Safety

API – Active Pharmaceutical Ingredient

ASMF – The Active Substance Master File – a document containing complete information on the manufacturing of an Active Pharmaceutical Ingredient



BASGAustrian Federal Office for Safety in Health Care

BDABulgarian Drug Agency

BfArMFederal Institute for Drugs and Medical Devices (Germany)

BLA – Biologic Licence Application – an application to approve a biological product in the US.



CBERCenter for Biologics Evaluation and Research – a department within the Food and Drug Administration (FDA) that regulates biological and related products for human use

CBGMedicines Evaluation Board (Netherlands)

CCDS or CDS – Company Core Data Sheet

CHMPCommittee for Medicinal Products for Human Use – the European Medicines Agency’s committee responsible for human medicines.

CMA – Conditional Marketing Authorisation (EU)

CMC – Chemistry, Manufacturing, and Controls

CSR – Clinical Study Report

CTA – Clinical Trial Application

CTD – Common Technical Document – an internationally agreed format for the preparation  and submission of application dossiers  in the participating regions; Europe, Japan and the US

CTRClinical Trials Regulation (EU)

DCP – Decentralised Procedure



DKMADanish Medicines Agency

DMF – Drug Master File –  A document containing complete information on an Active Pharmaceutical Ingredient or finished drug dosage form



EAMS – Early Access for Medicine Scheme (UK)

EAP – Expanded Access Program

EC – Ethics Committee; required in EU for approval of clinical trials

eCTD – Electronic Common Technical Document

EMAEuropean Medicines Agency

EOD – National Organization for Medicines (Greece)

EPAR – European Public Assessment Report – Published for every human medicine application that has been granted or refused a marketing authorisation

ERA – Environmental Risk Assessment



FAMHPFederal Agency for Medicines and Health Products (Belgium)

FDAFood and Drug Administration (US)

FIMEAFinnish Medicines Agency



GIFChief Pharmaceutical Inspectorate (Poland)



HALMEDAgency for Medicinal Products and Medical Devices of Croatia

HPRA Health Products Regulatory Authority (Ireland)



IBInvestigator Brochure – a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects.

ICH – International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use – an initiative that brings together the regulatory authorities of Europe, Japan and the US and associated experts from the pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration

IMAIcelandic Medicines Agency

IMP – Investigational Medicinal Product

IMPD – Investigational Medicinal Product Dossier –  a document or set of documents containing information on the quality, production and control of the medicinal product under investigation

IND – Investigational New Drug Application – an application to FDA to seek permission to test a new drug or biologic in humans and the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines in the US (usually to clinical investigators)

INFARMEDNational Authority of Medicines and Health Products (Portugal)

iPSP – Initial Pediatric Study Plan (US)

IRB – Institutional Review Board (US)

ISE – Integrated Summary of Efficiacy

ISS – Integrated Summary of Safety

IVDR – Invitro Diagnostics Regulation



JAZMPAgency for Medicinal Products and Medical Devices of the Republic of Slovenia



LLVMedicinal Products Control Agency (Liechtenstein)



MA – Medicines Authority (Malta)

MAAMarketing Authorisation Application

MAH – Marketing Authorisation Holder

MDR – Medical Device Regulations

MDSAP – Medical Device Single Audit Program

MHRAMedicines and Healthcare products Regulatory Agency (UK)

MRP – Mutual Recognition Procedure

MSMinistry of Health (Luxembourg)



NAMMDRNational Agency for Medicines and Medical Devices of Romania

NDA – New Drug Application – an application to approve a new drug in the US

NIMP – Non-Investigational Medicinal Product

NOMA – Norwegian Medicines Agency



ODD – Orphan Drug Designation – A status assigned to a medicine intended for use against a rare condition. The medicine must fulfil certain criteria for designation as an orphan medicine so that it can benefit from incentives such as protection from competition once on the market.

OGYEINational Institute of Pharmacy and Nutrition (Hungary)

OTC – Over the Counter



PDCO – Paediatric Committee – The European Medicines Agency (EMA) scientific committee: responsible for the assessment of the development of medicines in children

PDUFA – Prescription Drug User Fee Act (US)

PHS – Pharmaceutical Services – Ministry of Health (Cyprus)

PIL – Patient Information Leaflets a document contained within the medicinal product packaging that informs patients about the administration, precautions and potential side effects of the prescribed medication

PIP – Paediatric Investigation Plan

PMCF – Post Market Clinical Follow Up

PMPF – Post Market Performance Follow Up

PREA – Pediatric Research Equity Act (US)

PRIME – Priority Medicines program (EU)

PSUR – Periodic Safety Update Reports



RA – Regulatory Affairs

RMP – Risk Management Plan



SAG – Scientific Advisory Group (EU)

SAMState Agency of Medicines (Estonia)

SME – Small and Medium Enterprises

SMPASwedish Medical Products Agency

sNDA – Supplemental New Drug Application (US)

SPC or SmPC – Summary of Product Characteristics – A specific document required by European Medicines Agency (EMA) or MHRA (UK), summarising the key characteristics of a drug for which a Community marketing authorisation has been granted

SUKLState Institute for Drug Control (Czech Republic)

SUKLState Institute for Drug Control (Slovakia)



USPI – US Prescribing Information



VVKT – State Medicines Control Agency of Lithuania



ZVAState Agency of Medicines of the Republic of Latvia