Acronyms used at the Agency

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APIActive Pharmaceutical Ingredients
ASMFActive Substance Master File
BPCBulk Pharmaceutical Chemicals
BWPBiotech Working Party
CADREACCollaboration Agreement between Drug Regulatory Authorities of European Union Associated Countries
CAPsCentrally Authorised Products
CAVDRICollaboration Agreement between Veterinary Drug Registration Institutions
CEEC Central and Eastern European Countries
COMPCommittee on Orphan Medicinal Products
CHMPCommittee for Medicinal Products for Human Use
CTDCommon Technical Dossier
CVMPCommittee for Medicinal Products for Veterinary Use
DCPDecentralised Procedure
eCTDelectronic Common Technical Document
EDMFEuropean Drug Master File
EDQMEuropean Directorate for the Quality of Medicines and Healthcare
EEAEuropean Economic Area
EECEuropean Economic Community
EFPIAEuropean Federation of Pharmaceutical Industries and Associations
EPAREuropean Public Assessment Report
EWPEfficacy Working Party
GCPGood Clinical Practice
GLPGood Laboratory Practice
GMPGood Manufacturing Practice
HMPCCommittee on Herbal Medicinal Products
ICHInternational Conference for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
IFAHInternational Federation for Animal Health
ITFInnovation Task Force
IWPImmunologicals Working Party
MAHMarketing Authorisation Holder
MRAMutual Recognition Agreement
MRFGMutual Recognition Facilitation Group
MRPMutual Recognition Procedure
MSMember States
NTANotice To Applicants
OMCLOfficial Medicines Control Laboratories
PECAProtocol to the Europe Agreement on Conformity Assessment and Acceptance of industrial products
PERFPan European Regulatory Forum
PHAREPoland and Hungary; Aid of the Restructure of the Economy; Now the Phare programme is one of the three pre-accession instruments financed by the European Communities to assist the applicant countries of central Europe in their preparations for joining the European Union.
PhVWPPharmacovigilance Working Party
PICPharmaceutical Inspection Convention
PICSPharmaceutical Inspection Cooperation Scheme
PIMProduct Information Management
QRDQuality Review of Document
QWPQuality Working Party
S+TSampling and Testing
SMFSite Master File
VICHInternational Cooperation on Harmonization of Technical Requiremments for Registration of Veterinary Products
VMRFGVeterinary Mutual Recognition Facilitation Group
WHOWorld Health Organization

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