API       Active Pharmaceutical Ingredient
ASMF    Active Substance Master File
CDA      Confidential Disclosure Agreement
CEP      Certificate of Suitability to the Monograph of the European Pharmacopoeia
CMC     Chemistry - Manufacture - Control
CP        Centralised Procedure
CTD      Common Technical Document
DCP      Decentralised Procedure
DMF      Drug Master File
DRA      Drug Regulatory Affairs
EDMF     European Drug Master File
EU         European Union
FDA       Food and Drug Administration
GLP       Good Laboratory Practice
GMP      Good Manufacturing Practice
ICH       International Conference of Harmonisation
ICSR     Individual Case Safety Report
IMPD     Investigational Medicinal Product Dossier
IND       Investigational New Drug Application
MA        Marketing Authorisation
MAA      Marketing Authorisation Application
MRP      Mutual Recognition Procedure
NDA      New Drug Application
NtA       Notice to Applicants
PSUR    Periodic Safety Update Report
QOS     Quality Overall Summary
SOP      Standard Operating Procedure
SPC      Summary of Product Characteristics
US        United States

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