Wainwright Associates

ABPI

Association of the British Pharmaceutical Industry

ADME

Absorption, Distribution, Metabolism & Excretion

ADR

Adverse Drug Reaction

AE

Adverse Event

AEMPS

Agencia Española de Medicamentos y Productos Sanitarios (Spanish Medicines Agency) ·

AFSSAPS

Agence Française de Securité Sanitaire des Produits de Santé (French Medicines Agency)

AGES

The Austrian Agency for Health and Food Safety

AIFA

Agenzia Italiana del Farmaco (Italian Medicines Agency)

AIM

Active Ingredient Manufacturer

ANDA

Abbreviated New Drug Application (US)

API

Active Pharmaceutical Ingredient

AR

Assessment Report

ASMF

Active Substance Master File

ASPR

Anonymised Single Patient Report

ATC Code

Anatomical, Therapeutic and Chemical Classification (WHO)

BAN

British Approved Name

BfArM

Bundesinstitut für Arzneimittel and Medizinprodukte (German "Federal Institute for Drugs and Medical Devices")

BNF

British National Formulary

BP

British Pharmacopoeia

CA

Competent Authority

CAT

Committee for Advanced Technologies

CBG/MEB

College ter Beoordeling van Geneesmiddelen/Medicines Evaluation Board (Netherlands Medicines Agency)

CCDS

Company Core Datasheet

CCSI

Company Core Safety Information

CEP

Certificate of Suitability of European Pharmacopoeia

CFR

Code of Federal Regulations (US)

CHM

Commission on Human Medicines (UK)

CHMP

Committee for Medicinal Products for Human Use

CIOMS

Council for International Organisations of Medical Sciences

CMC

Chemistry, Manufacturing and Controls.

CMD(h)

Co-ordination Group (Human Medicines) for Mutual Recognition and Decentralised Procedures

CMD(v)

Co-ordination Group (Veterinary Medicines) for Mutual Recognition and Decentralised Procedures

CMS

Concerned Member State.

CoA

Certificate of Analysis

COA

Change of Ownership Application.

COMP

Committee for Orphan Medicinal Products

CP

Centralised Procedure

CRF

Case Report Form

CRO

Contract Research Organisation/Clinical Research Organisation

CT

Clinical Trial

CTA

Clinical Trial Authorisation

CTD

Common Technical Document

CVMP

Committee for Medicinal Products for Veterinary Use

DCP

Decentralised Procedure

DHPC

Direct Healthcare Professional Communication (aka ‘Dear Dr Letter’)

DLP

Data Lock Point

DKMA

The Danish Medicines Agency

DSUR

Development Safety Update Report

E2B

Refers to ICH E2B guidance on electronic reporting standards

eCTD

Electronic Common Technical Document

EDMF

European Drug Master File

EDQM

European Directorate for the Quality of Medicines and Healthcare

EFPIA

European Federation of Pharmaceutical Industries and Associates

EGA

European Generic Medicines Association

EMEA

European Medicines Agency

EPAR

European Public Assessment Report

ERA

Environmental Risk Assessment

EudraCT

European clinical trials data base

Eudravigilance

European adverse reaction data processing network and management

EuroPharm

Database of medicines authorised in the EU

EVCTM

Eudravigilance Clinical Trial Module

EVMPD

Eudravigilance Medicinal Products Dictionary

EVPM

Eudravigilance Post Authorisation Module

EVWEB

Eudravigilance Web browser

EWP

Efficacy Working Party.

FAQ

Frequently asked question

FDA

Food and Drug Administration (US)

FU

Farmacopoeia Ufficiale (Italian Pharmacopoeia)

FUM

Follow-up Measure

GCP

Good Clinical Practice.

GDP

Good Distribution Practice.

GLP

Good Laboratory Practice

GMO

Genetically Modified Organism

GMP

Good Manufacturing Practice

GPvP

Good Pharmacovigilance Practices.

GSL

General Sale List (UK)

GXP

A universal abbreviation for Good Practices.

HCP

Healthcare Professional

HMPC

Committee on Herbal Medicinal Products

IBD/EBD

International Birth Date/ European Birth Date

ICH

International Conference on Harmonisation.

ICSR

Individual Case Safety Report

IMB

Irish Medicines Board

IMP

Investigational Medicinal Product

IMPD

Investigational Medicinal Product Dossier

IND

Investigational New Drug (US)

INFARMED

Autoridade Nacional do Medicamento e Produtos de Saude (Portuguese Medicines Agency)

INN

International Non-proprietary Name

ISO

International Organisation for Standardisation

ITF

The Innovation Task Force (EMEA)

JP

Japanese Pharmacopoeia

LOI

List of Outstanding Issues (CHMP Questions)

LREC

Local Research Ethics Committee

MA

Marketing Authorisation

MAA

Marketing Authorisation Application

MAH

Marketing Authorisation Holder

MedDRA

Medical Dictionary for Drug Regulatory Activities

MHLW

Ministry of Health Labour and Welfare (Japan)

MHRA

Medicines and Healthcare products Regulatory Agency (UK)

MIMS?

Monthly Index of Medical Specialities

ML

Manufacturer’s Licence

MPA

The Medical Products Agency (Sweden)

MRA

Mutual Recognition Agreement.

MREC

Multicentre Research Ethics Committee

MRFG

Mutual Recognition Facilitation Group (now replaced by CMD(h))

MRP

Mutual Recognition Procedure

MS

Member State; a country which is a member of the European Union.

MTD

Maximum tolerated dose

NAM

National Agency for Medicines (Finnish Medicines Agency)

NCA

National Competent Authority

NCE

New Chemical Entity.

NDA

New Drug Application (US)

NeeS

Non-eCTD Electronic Submission

NF

National Formulary (US)

NoMA

The Norwegian Medicines Board

NTA

Notice to Applicants.

OTC

Over-The-Counter

PAC

Post-Approval Commitment

PAGB

Proprietary Association of Great Britain

PAR

Public Assessment Report

PASS

Post Authorisation Safety Study

PDCO

Paediatric Committee

Ph.Eur.

European Pharmacopoeia

PhVWP

Pharmacovigilance Working Party

PI

Product Information

PIC/S

The Pharmaceutical Inspection Correction and Pharmaceutical Inspection Co-operative Scheme

PIL

Patient Information Leaflet

PIM

Product Information Management

PIP

Paediatric Investigation Plan

PIPA

Pharmaceutical Information and Pharmacovigilance Association

PL

Package leaflet

PL

Product Licence. UK term for a Marketing Authorisation.

PL(PI)

Parallel Import Licence (UK)

PMDA

Pharmaceutical and Medical Devices Agency (Japan)

PMF

Plasma Master File

PMSS

Post Marketing Safety Surveillance

POM

Prescription only Medicine (UK)

PSUR

Periodic Safety Update Report

PUMA

Paediatric Use Marketing Authorisation

QA

Quality Assurance

QC

Quality Control

QP

Qualified Person

QPPV

Qualified Person for Pharmacovigilance

QRD

Quality Review of Documents

Rapporteur

CHMP (or CVMP) member that co-ordinates assessment of centralised MAA

RAPS

Regulatory Affairs Professionals Society (US)

RMS

Reference Member State

RSI

Request for Supplementary Information

SAE

Serious Adverse Event

SAWP

Scientific Advice Working Party

SFDA

State Food and Drug Administration (China)

SMF

Site Master File

SmPC

Summary of Product Characteristics

SO

Specific Obligation

SOC

System Organ Class

SOP

Standard Operating Procedure

SPC

Supplementary Protection Certificate
Also used for Summary of Product Characteristics

SUSAR

Suspected Unexpected Serious Adverse Reaction

Swissmedic

Swiss Agency for Therapeutic Products

TAG

Therapeutic Advisory Group

TGA

Therapeutic Goods Administration (Australia)

TOPRA

The Organisation for Professionals in Regulatory Affairs

TSE

Transmissible Spongiform Encephalopathies

USAN

United States Approved Name

USNF

United States National Formulary

USP

United States Pharmacopeia

USR

Urgent Safety Restriction

VAMF

Vaccine Antigen Master File

VAR

Variation Assessment Report

WDL

Wholesale Dealer’s Licence

WHO

World Health Organisation