AEMPS – Spanish Agency of Medicines and Medical Devices
AIFA – Italian Medicines Agency
ANDA – Abbreviated New Drug Application (US)
ANSM – French 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
BASG – Austrian Federal Office for Safety in Health Care
BDA – Bulgarian Drug Agency
BfArM – Federal Institute for Drugs and Medical Devices (Germany)
BLA – Biologic Licence Application – an application to approve a biological product in the US.
CBER – Center for Biologics Evaluation and Research – a department within the Food and Drug Administration (FDA) that regulates biological and related products for human use
CBG – Medicines Evaluation Board (Netherlands)
CCDS or CDS – Company Core Data Sheet
CHMP – Committee 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
CTR – Clinical Trials Regulation (EU)
DCP – Decentralised Procedure
DKMA – Danish 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
EMA – European 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
FAMHP – Federal Agency for Medicines and Health Products (Belgium)
FDA – Food and Drug Administration (US)
FIMEA – Finnish Medicines Agency
GIF – Chief Pharmaceutical Inspectorate (Poland)
HALMED – Agency for Medicinal Products and Medical Devices of Croatia
HPRA – Health Products Regulatory Authority (Ireland)
IB – Investigator 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
IMA – Icelandic 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)
INFARMED – National 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
JAZMP – Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
LLV – Medicinal Products Control Agency (Liechtenstein)
MA – Medicines Authority (Malta)
MAA – Marketing Authorisation Application
MAH – Marketing Authorisation Holder
MDR – Medical Device Regulations
MDSAP – Medical Device Single Audit Program
MHRA – Medicines and Healthcare products Regulatory Agency (UK)
MRP – Mutual Recognition Procedure
MS – Ministry of Health (Luxembourg)
NAMMDR – National 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.
OGYEI – National 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)
SAM – State Agency of Medicines (Estonia)
SME – Small and Medium Enterprises
SMPA – Swedish 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
SUKL – State Institute for Drug Control (Czech Republic)
SUKL – State Institute for Drug Control (Slovakia)
USPI – US Prescribing Information
VVKT – State Medicines Control Agency of Lithuania
ZVA – State Agency of Medicines of the Republic of Latvia