| Abbreviation | Term |
| ABPI | Association of British Pharmaceutical Industry |
| ADR | Adverse drug reaction |
| AE/SAE | Adverse event/Serious adverse event |
| AIM | Active ingredient manufacturer |
| ANDA | Abbreviated New Drug Application (US generic marketing application) |
| ATC | Anatomical Therapeutic Chemical code |
| AWMSG | All-Wales Medicines Strategy Group |
| BARQA | British Association of Research Quality Assurance |
| BLA | Biologic License Application |
| BNF | British National Formulary |
| BP | British Pharmacopoeia |
| BWP | Biotechnology Working Party (CHMP) |
| CCDS | Company core data sheet |
| CDER/CBER | Centre for Drug Evaluation and Research/Centre for Biological Evaluation and Research (US) |
| CE | Conformité European (marking for EU medical devices) |
| CEP (COS) | Certificate of Suitability of the European Pharmacopoeia |
| CFR | Code of Federal Regulations |
| CIOMS | Committee for International Organisation of Medical Sciences |
| CHMP | Committee for Medicinal Products for Human Use |
| CMD | Co-ordination Group for Mutual Recognition and Decentralised Procedures |
| CMS | Concerned Member State |
| COMP | Committee for Orphan Medicinal Products |
| CVMP | Committee for Medicinal Products for Veterinary Use |
| CP | Centralised procedure |
| CRF | Case report/record form |
| CSR/CTR | Clinical study report/clinical trial report |
| CTA | Clinical Trial Authorisation |
| CTD | Common Technical Document |
| CTD | Clinical Trials Directive |
| CTMP | Clinical Trial of a Marketed Product |
| DCP | Decentralised procedure |
| DDD | Defined Daily Dose |
| DMF | Drug master file |
| DSUR | Developmental Safety Update Report |
| EC | Ethics Committee |
| eCTD | Electronic Common Technical Document |
| EDC | Electronic Data Capture |
| EDMF | European Drug Master File |
| EDQM | European Directorate for the Quality of Medicines |
| EEA | European Economic Area |
| EMA | European Medicines Agency |
| EPAR | European Public Assessment Report |
| EP/Ph Eur | European Pharmacopoeia |
| ERA | Environmental Risk Assessment |
| ESTRI | Electronic Standards for the Transfer of Regulatory Information |
| EUDRACT | EU Clinical Trial Database |
| EV | Eudravigilance |
| EVMPD | Eudravigilance Medicinal Product Dictionary |
| EWP | Efficacy Working Party (CHMP) |
| FDA | Food and Drug Administration (US) |
| FOIA | Freedom of Information Act |
| GCP/GDP/GLP/GMP/GPvP | Good Clinical / Distribution / Laboratory / Manufacturing / Pharmacovigilance Practice |
| GMO | Genetically Modified Organism |
| GSL | General Sales List |
| HMA | Heads of Medicines Agencies |
| HMPC | Committee for Herbal Medicinal Products |
| HPB | Health Protection Branch (CAN) |
| HTA | Health Technology Assessment |
| IB | Investigators Brochure |
| IBD | International Birth Date |
| ICH | International Committee for Harmonisation |
| ICSR | Individual Case Safety Report |
| IMB | Irish Medicines Board |
| IMP | Investigational Medicinal Product |
| IMPD | Investigational Medicinal Product Dossier |
| IND | Investigational New Drug |
| INN | International Non-proprietary Name |
| IRB | Institutional Review Board |
| ISS/ISE | Integrated summary of safety/integrated summary of efficacy |
| ISSN/ISBN | International standard serial number/International standard book number |
| JNDA | Japanese New Drug Application |
| LREC | Local Research Ethics Committee |
| MAA | Marketing Authorisation Application |
| MAH | Marketing Authorisation Holder |
| MedDRA | Medical Dictionary for Regulatory Activities |
| MHLW | Ministry of Health, Labour and Welfare (Japan) |
| ML | Manufacturers Licence |
| MRP | Mutual Recognition Procedure |
| MREC | Multicentre Research Ethics Committee |
| NDA | New Drug Application |
| NICE | National Institute for Health and Clinical Excellence |
| NME | New molecular entity |
| OTC | Over the counter |
| P | Pharmacy medicine |
| PAES | Post-Authorisation Efficacy Study |
| PAGB | Proprietary Association of Great Britain |
| PAR | Public Assessment Report |
| PASS | Post-Authorisation Safety Study |
| PhVWG | Pharmacovigilance Working Party (CHMP) |
| PI | Package Insert |
| PIL | Patient Information Leaflet |
| PIQ | Product Information Quality Review Group (MHRA) |
| PL | Product Licence |
| PL | Package Leaflet |
| PMCPA | Prescription Medicines Code of Practice Authority |
| POM | Prescription only medicine |
| PSUR | Periodic Safety Update Report |
| PV | Pharmacovigilance |
| PVAR | Preliminary Variation Assessment Report |
| QA | Quality Assurance |
| QC | Quality Control |
| QP | Qualified Person |
| RAPS | Regulatory Affairs Professionals Society (US) |
| RMP | Risk Management Plan |
| RMS | Reference Member State |
| SAG | Scientific Advisory Group (EMA) |
| SAP | Statistical Analysis Plan |
| SAS | Statistical Analytical Software |
| SAWG | Scientific Advice Working Party (EMA) |
| SBA | Summary Basis of Approval |
| SMC | Scottish Medicines Consortium |
| SMF | Site Master File |
| SPC/SmPC | Summary of Product Characteristics |
| SNDA | Supplementary New Drug Application |
| SOP | Standard Operating Procedure |
| SUSAR | Suspected Unexpected Serious Adverse Reaction |
| SWP | Safety Working Party (CHMP) |
| TAG | Therapeutic Advisory Group |
| TGA | Therapeutic Goods Administration (Australia) |
| TOPRA | The Organisation for Professionals in Regulatory Affairs |
| USP | United States Pharmacopoiea |
| WHO | World Health Organisation |
Company Information
Downloads & Resources
Memberships
Spectrum staff are actively involved in key professional organisations.
International Services
