COMMON INDUSTRY ACRONYMS & ABBREVIATIONS

嚜澶LOSSARY OF REGULATORY HEALTHCARE ACRONYMS & ABBREVIATIONS

glossary

Note: Medical prescription abbreviations can be found at acronyms/PRESCRIPTION

1-1-1 每 One dossier, one European scientific assessment, one decision for marketing authorisation

3Rs 每 Replacement, refinement and reduction (in research using animals)

510(k) 每 Medical device premarket notification (US FDA)

AA 每 Accelerated assessment/approval

AAC 每 Accelerated Access Collaborative (UK)

AADA 每 Abbreviated antibiotic drug application

AAP 每 Accelerated approval pathway (US) 每 and also:

AAP 每 Accelerated assessment procedure (EU)

AAPS 每 American Association of Pharmaceutical Scientists

AAR 每 Accelerated access review

AAS 每 Atomic absorption spectroscopy

AAV 每 Adeno-associated virus

ABHI 每 Association of British Healthcare Industries (medical devices sector)

ABPI 每 Association of the British Pharmaceutical Industry

A-CASI 每 Audio computer-assisted self-interviewing

ACO 每 Addendum to clinical overview

ACRP 每 Association of Clinical Research Professionals

ACSS 每 Australia, Canada, Singapore, Switzerland Consortium

ACT 每 Artemisinin-based combination therapy

ACTD 每 ASEAN common technical dossier (see ASEAN)

ACVM 每 Agricultural Compounds and Veterinary Medicines (New Zealand)

ADA 每 Anti-drug antibodies

ADaM 每 Analysis data model

ADC 每 Additional data collection 每 and also:

ADC 每 Antibody每drug conjugate

ADCC 每 Antibody-dependent cellular cytotoxicity

ADE 每 Adverse device event (AE judged to be related to the medical device)

ADEC 每 Australian Drug Evaluation Committee

ADI 每 Acceptable daily intake

ADME 每 Absorption, distribution, metabolism and excretion/elimination (also AME 每 absorption, metabolism,

excretion/elimination)

ADR 每 Adverse drug reaction

ADROIT 每 Adverse Drug Reactions On-Line Tracking System

ADVAC 每 Ad hoc group on veterinary vaccine availability (CVMP)

ADVENT 每 Ad Hoc Expert Group on Veterinary Novel Therapies

AE 每 Adverse event

AEFI 每 Adverse event following immunisation

AEGIS 每 Adverse Experience Gathering Information System

AEM 每 Agencia Espanola Medicamento (Spain)

AEMPS 每 Agencia Espa?ola de Medicamentos y Productos Sanitarios (Spain)

AEPAR 每 Associaci車n Espa?ola de Profesionales de Actividades de Registro (Spanish Regulatory Affairs

Association)

AERS 每 Adverse event reporting system (US FDA)

AESGP 每 Association Europ谷enne des Sp谷cialiti谷s Pharmaceutiques Grand Public (Association of the European

Self-Medication Industry)

AF 每 Application Form

AFAR 每 Association Fran?aise des Affaires Regl谷mentaires (French Regulatory Affairs Association)

AFDO 每 Association of Food and Drug Officials (US)

AFMPS 每 Agence F谷d谷rale des M谷dicaments et des Produits de Sant谷 (Belgium)

Afssaps 每 former French regulatory agency (Agence Fran?aise de S谷curit谷 Sanitaire des Produits de Sant谷) 每

replaced by ANSM in 2012 (see below)

AGES PharmMED 每 Osterreichische Agentur fur Gesundheit und Ernahrungssicherheit GmbH (Austria＊s medicines

& devices agency)

AHSC 每 Academic Health Science Centre (UK)

AHWP 每 Asian Harmonisation Working Party

AI 每 Adverse incident (medical devices sector) 每 and also:

AI 每 Artificial intelligence

AIFA 每 Agenzia Italiana del Farmaco (Italy's health authority)

AIM 每 Active ingredient manufacturer

AIMD 每 Active implantable medical device

AITS 每 Adverse Incident Tracking System (medical devices sector)

AKP 每 Alkaline phosphatase

ALARP 每 As low as reasonably practical

ALATF 每 As low as technically feasible (terminology superseded by ※ALARP§ 每 see above)

ALIMS 每 Medicines and Medical Devices Agency (Serbia)

ALL 每 Acute lymphocytic leukaemia

ALT 每 Alanine aminotransferase (ALT = SGPT)

AM 每 Agence du Medicament (France)

AMA 每 American Medical Association

AMEG 每 AntiMicrobial advice ad hoc Expert Group

AMI 每 Acute myocardial infarct

AML 每 Acute myeloid leukemia

AMM 每 Autorisation de mise sur le march谷 (France) = Product licence

AMP 每 Authorised medicinal product 每 and also:

AMP 每 Auxiliary medicinal product (formerly non-investigational medicinal product, NIMP)

AMR 每 Antimicrobial resistance

AMRH 每 African Medicines Regulatory Harmonisation

ANADA 每 Abbreviated New Animal Drug Application (US)

ANDA 每 Abbreviated new drug application

ANDS 每 Abbreviated new drug submission (Canada)

ANMV 每 Agence nationale du m谷dicament v谷t谷rinaire (French vet medicines agency)

ANOVA 每 Analysis of Variance

ANPR 每 Advanced notice of proposed rulemaking (US)

ANSES 每 Agence Francaise de Securite Sanitaire des Aliments Agence nationale due medicament veterinaire

ANSM 每 French regulatory agency (Agence nationale de s谷curit谷 du m谷dicament et des produits de sant谷)

[formerly Afssaps]

ANZTPA 每 Australia New Zealand Therapeutic Products Agency (scheduled to come into force in 2016 每 replacing

Australia＊s TGA and New Zealand＊s Medsafe)

AO 每 Auditing organisation

AOAC 每 Association of Official Analytical Chemists (US)

AOB 每 Any other business

AP 每 Accredited person 每 and also:

AP 每 Adaptive pathway

APEC 每 Asia-Pacific Economic Cooperation

APHIS 每 Animal and Plant Health Inspection Service (US)

API 每 Active pharmaceutical ingredient

APIC 每 Active Pharmaceutical Ingredients Committee

APLB 每 Advertising and Promotional Labeling Branch (FDA＊s CBER)

APMA 每 Australian Pharmaceutical Manufacturers Association

APVA 每 Additional pharmacovigilance activities

APVMA 每 Australian Pesticides and Veterinary Medicines Authority (Australia)

AQL 每 Acceptable quality level

AR 每 Adverse reaction 每 and also:

AR 每 Assessment Report (EU) 每 and also:

AR 每 Authorised representative

ARfD 每 Acute reference dose (veterinary)

ARMAs 每 Additional risk minimisation activities

ARMMs 每 Additional risk minimisation measures

AS 每 Active Substance

ASAP 每 Accelerated Stability Assessment Program

ASCII 每 American Standard Code for Information Interchange Quality Assurance

ASDI每 Acceptable single-dose intake

ASEAN 每 Association of Southeast Asian Nations

ASMF 每 Active Substance Master File

ASMF WG 每 Working Group on Active Substance Master File procedures

ASPR 每 Anonymised single patient report (formerly ASPP 每 anonymised single patient printout)

ASR 每 Annual safety report

AST 每 Aspartate aminotransaminase (AST = SGOT)

ATA 每 Alternatives to antibiotics

ATC 每 Anatomical 每 therapeutic 每 chemical (WHO) 每 and also:

ATC 每 Animal Test Certificate (UK) 每 and also:

ATC Code 每 Anatomical Therapeutic Chemical Code

ATC Vet Code 每 Anatomical Therapeutic Chemical Veterinary Code

ATC(/DDD) 每 Anatomical Therapeutic Chemical classification system (with Defined Daily Doses)

ATD 每 Access to documents (EMA policy) 每 and also:

ATD 每 Anticipated therapeutic dose 每 and also:

ATD 每 Anti-tampering device

ATECT 每 Advanced T-cell Engineering for Cancer Therapy

ATF 每 Alcohol 每 Tobacco and Firearms (Bureau of) (US)

ATMPs 每 Advanced therapy medicinal products (aka ※advanced therapies§)

ATU 每 Authorisation for temporary use

AUC? 每 Area under the concentration time curve between zero and infinity

AUCx 每 Area under the curve during a given time

AVEG 每 AIDS Vaccine Evaluation Group

AWP 每 Antimicrobials Working Party

AXREM 每 Association of X-ray Equipment Manufacturers

AYA 每 Adolescents and young adults

BBB

BA 每 Bioavailability

BA/BE 每 Bioavailability/bioequivalence

BACPAC 每 Bulk active chemical post approval changes (US)

BAI 每 Breath actuated inhaler

BAID 每 Batch identifier

BAN 每 British Approved Name

BAP 每 Biotechnology Action Programme/Biosimilars Action Plan

BARQA 每 British Association of Research Quality Assurance

BCS 每 Biopharmaceutics Classification System

bd/bid 每 twice a day (Latin: bis in die)

BDA 每 Bulgarian drug agency

BE 每 Bioequivalence

BEMA 每 Benchmarking of European Medicines Agencies

BfArM 每 Federal Institute for Drugs and Medical Devices (Bundesinstituts f邦r Arzneimittel und Medizinprodukte)

(Germany＊s regulatory authority)

BGMA 每 British Generic Manufacturers Association

BIND 每 Biological investigational new drug

BIO 每 Biotechnology Industry Organization (US)

BLA 每 Biologics license application (US)

BM 每 Bone marrow

BMA 每 British Medical Association

BMD 每 Bone mineral density

BMG 每 Bundesministerium f邦r Gesundheit = Federal Ministry of Health (Germany)

BMGF 每 Bundesministerium fuer Gesundheit und Frauen (Austrian agency)

BMWP 每 Biosimilar Medicinal Products Working Party

BNF 每 British National Formulary

BoH 每 Board of Health

BOS 每 Break-out session

BP 每 Blood pressure 每 and also:

BP 每 British Pharmacopoeia

BPC 每 British Pharmacopoeia Commission 每 and also:

BPC 每 Bulk pharmaceutical chemicals

BPCA 每 Best Pharmaceuticals in Children Act (US)

BPG 每 Best Practice Guide

BPI 每 Bundesverband der Pharmazeutischen Industrie (German pharmaceutical industry trade association)

BPR 每 Biocidal Products Regulation

BPWP 每 Blood Products Working Party (EMA)

Br 每 Barrier reared (in older reports 每 ＆Brown＊)

BRAS 每 Belgian Regulatory Affairs Society

BRAT 每 Benefit每Risk Action Team

BRIC 每 Brazil, Russia, India & China

BRICK每 Brazil, Russia, India, China & (South) Korea

BRICS 每 Brazil, Russia, India, China & South Africa

BROMI 每 Better Regulation of Over the Counter Medicines Initiative

BSE 每 Bovine Spongiform Encephalopathy

BTD 每 Breakthrough therapy designation (US)

BTDR 每 Breakthrough therapy designation request

BTF 每 Brexit Task Force

BWP 每 Biotech Working Party (EMA)

CCC

C&P 每 Chemistry and Pharmacy

CA 每 Commercial appraisal 每 and also:

CA 每 Competent authority

CAC 每 Codex Alimentarius Commission (veterinary sector)

CAD 每 Coronary artery disease

CADREAC 每 Collaboration agreement between drug regulatory authorities of European Union associated countries

(also nCADREAC 每 new Collaboration Agreement)

CADTH 每 Canadian Agency for Drugs and Technologies in Health (formerly CCOHTA)

CAMD 每 Competent Authorities for Medical Devices

CAMS 每 Chinese Academy of Medical Sciences

CANDA 每 Computer assisted new drug application

CAO 每 Central Agricultural Office (Hungary)

CAP 每 Centrally authorised product

CAPA 每 Corrective action and preventive action

CAPA plan 每 Corrective and preventive action plan

CAPLA 每 Computer Assisted Product Licence Application

CAPRA 每 Canadian Association of Pharmaceutical Regulatory Affairs

CAR 每 Chimeric antigen receptor

CARPHA 每 The Caribbean Public Health Agency

CAS 每 Central alerting system (UK) 每 and also:

CAS 每 Chemical abstract systems

CAT 每 Committee for Advanced Therapies (EMA)

CATMP 每 Combined Advanced Therapy Medicinal Product

CAVDRI 每 Collaboration agreement between veterinary drug registration institutions

CAVOMP 每 Clinical added value orphan medicinal product

CBER 每 Center for Biologics Evaluation and Research (US FDA)

CBG/MEB 每 Medicines Evaluation Board (the Netherlands)

CBP 每 Corticoid binding protein

CC 每 Candidate country (EU)

CCDP 每 Complete clinical data package

CCDS 每 Company core data sheet

CCG 每 Clinical Commissioning Group (UK NHS)

CCG IAC 每 Clinical Commissioning Group Indicator Advisory Committee

CGTPs 每 Cell and gene therapy products

CCI 每 Commercially confidential information

CCRB 每 Change control review board

CCSI 每 Company core safety information

CD 每 Caesarean derived 每 and also:

CD 每 Controlled drug

CDA 每 China Drug Administration

CDC 每 Centers for Disease Control and Prevention (US)

CDDD 每 Clinical dossier of drug development (Brazil)

CDE 每 Center for Drug Evaluation (China)

CDEC 每 Canadian Drug Expert Committee (Canada)

CDER 每 Center for Drug Evaluation and Research (US FDA)

CDISC 每 Clinical Data Interchange Standards Consortium

CDMA 每 Canadian Drug Manufacturers Association

CDR 每 Common Drug Review (Canada)

CDRH 每 Center for Devices and Radiological Health (US FDA)

CDS 每 Clinical decision support

CDSCO 每 Central Drug Standard Organization (India＊s clinical trials licensing authority)

CDSM 每 Committee on Dental and Surgical Materials (UK)

CDx 每 Companion Diagnostics

CE Mark 每 Conformit谷 European (approval for EU medical devices)

CEA 每 Cost-effectiveness analysis

CEC 每 Central ethics committee 每 and also:

CEC 每 Commission of the European Communities

CED 每 Coverage with evidence development

CEE 每 Central and Eastern Europe

CEEC 每 Central and Eastern European Countries

CEFTA 每 Central Europe Free Trade Area

CEN 每 Comit谷 Europ谷an des Normes 每 European Committee for Standardization

CEP 每 Central enquiry point (MHRA) 每 and also:

CEP 每 Certificate of European Pharmacopoeia (aka Certificate of Suitability)

CER 每 Clinical evaluation report 每 and also:

CER 每 Comparative effectiveness research

CESP 每 Common European submission portal

CF 每 Cystic fibrosis

CFC 每 Chlorofluorocarbons

CFDA 每 China Food and Drug Administration (formerly State FDA 每 SFDA)

CFR 每 Code of Federal Regulations (US)

CFS 每 Certificate of Free Sale

CFSAN 每 Center for Food Safety and Applied Nutrition (US)

cGLP 每 Current good laboratory practice

cGMP 每 Current good manufacturing practice

CGP 每 Clinical Guidance Panel (Canada)

CH 每 Clinical hold

CHAI 每 Commission for Healthcare Audit and Inspection (UK)

CHC 每 Consumer healthcare

CHMB - Creatine kinase Muscle Brain

CHMP 每 Committee for Medicinal Products for Human Use (EMA)

CHMP 每 Committee for Medicinal Products for Human Use (previously: CPMP)

CHO 每 Chinese hamster ovary cells

CHPA 每 Consumer Healthcare Products Association

CI 每 Confidence Interval, and also:

CI 每 Contraindication

CIA 每 Corporate Integrity Agreement (US)

CIOMS 每 Council for International Organizations of Medical Sciences (WHO)

CIRS 每 Centre for Innovation in Regulatory Science

CIS (countries) 每 Commonwealth of Independent States (members are former Soviet Republic countries,

currently including Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Usbekistan,

Turkmenistan, Ukraine

CK 每 Creatine kinase

Cl 每 Total body clearance

Class Im 每 Class I with measuring function (medical devices)

CLIA 每 Clinical Laboratory Improvement Amendments (US)

CLL 每 Chronic lymphocytic leukaemia

CLO 每 Clinical overview

CLP 每 Classification, labelling and packaging (medical devices)

CLS 每 Clinical summary

Cm or Cmax 每 Maximum plasma concentration at steady state

CMA 每 Conditional marketing authorisation (US)

CMC 每 Chemistry, manufacturing, and controls

CMDCAS 每 Canadian Medical Devices Conformity Assessment System

CMDh 每 Co-ordination Group for Mutual Recognition and Decentralised Procedures 每 Human (EMA)

CMDR 每 Canadian Medical Device Regulation

CMDv 每 Co-ordination Group for Mutual Recognition and Decentralised Procedures 每 Veterinary (EMA)

CMN 每 Comit谷 de Mol谷culas Nuevas§ (New Molecules Committee) (Mexico)

CMP 每 Certificate of Medicinal Product 每 and also:

CMP 每 Common product model

CMR 每 Carcinogenic, mutagenic or reprotoxic [toxic to reproduction] 每 and also:

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