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