ABBREVIATIONS & ACRONYMS RELEVANT TO APIs - May 2000

AAPS
AESGP
ANDA
APIC
BP
BSE
CEO
CEFIC
CPMP
CVMP
CRO
CTD
DIA
DOE
DSHEA
GCP
GMO
GMP
GLP
EDQM
EGA
EMEA
EFPIA
EUR PH
FDA
FEDESA
GPIA
ICH
IFPMA
IGPA
IPEC
ISPE
MCA
NAFTA
NAPM
NAS
NCE
NDA
NIST
NPA
OC
OEM
PCR
PDUFA
PEFRAS
PhARMA
PIC
PICS

American Association of Pharmaceutical Scientists

Association Europenne des Specialits Grand Public
Abbreviated New Drug Application
Active Pharmaceutical Ingredients Committee
British Pharmacopoeia
Bovine Spongiform Encephalopathy
Chief/Corporate Executive Officer
European Chemical Industry Council
Committee of Proprietary Medicinal Products (EU)
Committee of Proprietary Veterinary Products (EU)
Contract Research Organization
Common Technical Document (Register ICH)
Drug Information Association (USA)
Department of Energy (USA)
Dietary Suplement Health and Education Act (USA)
Good Clinical Practice
Genetically Modified Organisms
Good Manufacturing Practice
Good Laboratory Practice (For Safety Evaluation)
European Directorate for the Quality of Medicines
European Generics Association
European Medicines Evaluation Agency
European Federation of Pharmaceutical Industries Associations
European Pharmacopoeia (Commission)
Food and Drug Administration (USA)
Federation Europenne de la Sant Animale
Generic Pharmaceutical Industry Association
International Conference of Harmonization
International Federation of Pharmaceutical Manufacturers Associations
International Generic Pharmaceutical Association
International Pharmaceutical Excipients Council
International Society for Pharmaceutical Engineering
Medicines Control Agency (UK)
North American Free Trade Agreement
National Association of Pharmaceutical Manufacturers
National Academy of Sciences (USA)
New Chemical Entity
New Drug Application
National Institute of Science and Technology (USA)
National Pharmaceutical Alliance
Oral Contraceptive
Original Equipment Manufacturer
Polymerase Chain Reaction
Prescription Drug User Fee Act (USA, 1992)
Pan European Federation of Regulatory Affairs Society
Pharmaceutical Association of Research-based Manufacturers (PMA, USA)
Pharmaceutical Inspection Convention (EFTA)
Pharmaceutical Inspection Cooperation Scheme

ABBREVIATIONS & ACRONYMS RELEVANT TO APIs - May 2000

PTO
SMO
SPC
SRM
TSE
USP
VFA
VOC
WHO
WTO

Patent and Trademark Office (USA)

Site Management Organization
Summary of Product Characteristics (EU, DMF per Mutual Recognition
Procedure) /// Statistical Process Control
Specified Risk Material (EU)
Transmissible Spongiform Encephalopathies (Veure BSE)
United States Pharmacopoeia
Verband der Forschender Artzneitmittelherstellern
Volatile Organic Compound
World Health Organization (OMS)
World Trade Organization