Sunday, 28 June 2020

Pharmaceutical Regulatory Affairs - Glossary of acronyms and abbreviations


Pharmaceutical Regulatory Affairs - Glossary of acronyms and abbreviations

 

A

AADA

Abbreviated antibiotic drug application

ABHI

Association of British Healthcare Industries

ABPI

Association of the British Pharmaceutical Industry

ACTD

ASEAN common technical dossier

ADC

Additional Data Collection

ADI

Acceptable daily Intake

ADR

Adverse drug reaction

AE

Adverse event

AEFI

Adverse event following immunization

AEMPS

Agencia Española de Medicamentos y Productos Sanitarios (Spanish Medicines and Healthcare Products Agency)

AGES

Austrian Agency for Health and Food Safety

AIFA

Agenzia Italiana del Farmaco (Italian Medicines Agency)

AIM

Active ingredient manufacturer

AIMD

Active implantable medical device

ANDA

Abbreviated new drug application

ANSM

Agence nationale de sécurité du médicament et des produits de santé (French Medicines Agency)

API

Active pharmaceutical ingredient

AQL

Acceptable quality level

AR

Assessment Report (European Union)

ASMF

Active Substance Master File

ASR

Annual safety report

ATMPs

Advanced therapy medicinal products

ATC

Anatomical Therapeutic Chemical

B

BA

Bioavailability

BAN

British Approved Name

BAP

Biotechnology Action Programme

BfArM

Bundesinstitut für Arzneimittel und Medisinprodukte (Federal Institute for Drugs and Medical Devices in Germany)

BIND

Biological investigational new drug

BNF

British National Formulary

BOS

Break-out session (happens during a DCP/MRP/CP)

BP

British Pharmacopoeia

BWP

Biotech Working Party (EMA)

C

C&P

Chemistry and Pharmacy

CA

Commercial appraisal

CA

Competent authority (a medicines regulatory authority in the European Union)

CANDA

Computer assisted new drug application

CAP

Centrally authorised product

CAPA

Corrective action and preventive action

CAPLA

Computer Assisted Product Licence Application

CC

Candidate country

CCDS

Company core data sheet

CCG

Clinical Commissioning Group (UK)

CD

Controlled drug

CDSCO

Central Drugs Standard Control Organisation

CEP

Certification of suitability to the Monographs of the European Pharmacopoeia

CHMP

Committee for Medicinal Products for Human Use

cGLP

Current good laboratory practice

cGMP

Current good manufacturing practice

Cl

Total body clearance

CIOMS

Council for International Organisations of Medical Sciences

CLO

Clinical overview

CLS

Clinical summary

CMC

Chemistry- manufacturing- controls

CMDh

Co-ordination group for Mutual recognition and Decentralised procedures – Human

CMDv

Co-ordination group for Mutual recognition and Decentralised procedures – Veterinary

CMP

Certificate of Medicinal Product

CMS

Concerned Member State (European Union)

CO

clinical overview

COA

Certificate of analysis

CoFS

Certificate of Free Sale

COMP

Committee on Orphan Medicinal Products

CP

Centralised procedure (European Union)

CP

Comparability protocol (USA)

CPD

Continuing professional development

CPP

Certificate of pharmaceutical product

CPP

Critical process parameter

CQA

Clinical quality assurance

CR

Controlled release

CRF

Case report form

CRO

Clinical Research Organisation

CRO

Contract research organisation

CSI

Core safety information

CSP

Core safety profile

CSR

Clinical study report (European Union)

CT

Clinical trial

CTA

Clinical trial application

CTA

Clinical trial authorisation

CTC

Clinical trial certificate (UK)

CTD

Clinical Trials Directive

CTD

Common technical document/dossier

CTMS

Clinical trial management system

CTS

Common technical specification

CTX

Clinical trial exemption (UK)

CVM

Center for Veterinary Medicine (US)

D

DACS

Detailed and critical summary

DAE

Discontinuation due to an adverse event

DCP

Decentralised procedure

DDD

Defined daily dose

DDPS

Detailed description of pharmacovigilance system

DMF

Drug master file

DMS

Document management system

DOE

Design of experiments

DP

Drug product

DS

Drug substance

DSUR

Development safety update report

DTC

Direct-to-consumer

DUS

Drug utilisation study

E

EA

Environmental assessment

EC

Ethics committee

eCTD

Electronic common technical document

EDC

Electronic data capture

EDQM

European Directorate for the Quality of Medicines & Healthcare

EDMF

European drug master file

EDT

Electronic data transfer

EEA

European economic area

EMA

European Medicines Agency

ENS

Early notification system

EP

European Pharmacopeia

EPI

Essential Program for Immunisation

EPL

Effective patent life

ePSUR

Eelectronic periodic safety update report

ERA

Environmental risk assessment

ERB

Ethical review board

ESPAR

Executive Summary Pharmacovigilance Assessment Report

EWG

Expert Working Group

EWP

Efficacy Working Party

F

FAMHP

Federal Agency for Medicines and Health Products (of Belgium)

FAR

Final assessment report

FAR

Field Alert Report

FDA

Food and Drug Administration

FMEA

Failure mode and effects analysis

FIMEA

Finnish Medicines Agency

FTE

Full Time Equivalent

G

GCP

Good clinical practice

GDP

Good distribution practice

GGP

Good guidance practice

GLP

Good laboratory practice

GMO

Genetically modified organism

GMP

Good manufacturing practice

GMP

Good management practice

GPP

Good paediatric practice

GPP

Good pharmacoepidemiology practice

GpvP

Good pharmacovigilance practice

GRB

Global Regulatory Board

GRP

Good regulatory practice

GSL

General sales list

GSP

Good statistics practice

GVP

Good pharmacovigilance practice

H

HCP

Healthcare professional

HEOR

Health economics and outcomes research

HMA

Heads of Medicines Agencies (EU)

HPRA

Health Product Regulatory Authority

HREC

Human Research Ethics Committee

HTA

Health technology assessment

HTS

High-throughput screening

I

IB

Investigator’s brochure

IC

Informed consent

ICH

International Council on Harmonisation

ICD

Informed consent document

ICSR

Individual case safety report

IDE

Investigational Device Exemption

IDMP

Identification of medicinal products

IEC

Independent ethics committee

IM

Issue management

IMA

Icelandic Medicines Agency

IMI

Innovative Medicines Initiative

IMP

Investigational medicinal product

IMPD

Investigational medicinal product dossier

IMRDF

International Medical Device Regulatory Forum

IMS

Information management strategy

INN

International non –proprietary names

INDA

Investigational new drug application (USA)

INDC

Investigational New Drug Committee

IP

Intellectual property

IPO

Intellectual Property Office

IPR

Intellectual property rights

IQM

Integrated quality management

IRB

Institutional review board

IRD

International registration document

IRN

Incident Review Network

IS

Internal standard

ISE

Integrated summary of efficacy

ISRB

Integrated summary of risk benefit

ISS

Integrated summary of safety

K

KIT

Key intelligence topic

KM

Knowledge management

KOL

Key opinion leader

L

LCM

Lifecycle management

LED

Least Effect Dose

LLL

Lifelong learning

LOA

letter of authorisation

                                      M

MA

Marketing authorisation

MAA

Marketing authorisation application (EU)

MAH

Marketing authorisation holder

MAIL

Medicines act information letter (UK)

MAL

Medicines Act Leaflet (UK)

MAT

Marketing authorisation transfer

MDCG

Medical Device Coordination Group

MDD

Medical Device Directive

MDEG

Medical Device Expert Group

MDLO

Medical Device Liaison Officer

MDR

Medical device reporting

MedDRA

Medical Dictionary for Regulatory Activities

MERS

Multi-agency electronic regulatory system

MHRA

Medicines and Healthcare products Regulatory Agency (UK)

ML

Manufacturer’s licence (UK)

MOU

Memorandum of Understanding

MRA

Mutual recognition agreement

MRP

Mutual recognition procedure

MS

Member state(EU)

N

NAP

Nationally authorised product

NBE

New biological entity

NCA

National Competent Authority

NCE

New chemical entity

NCO

Non clinical overview

NCS

Non clinical summary

NDAC

New Drug Advisory Committee (India)

NED

Non effect dose

NIMP

Non-investigational medicinal product

NME

New molecular entity

NOMA

The Norwegian Medicines Agency

O

OD

Orphan drug

ODA

Orphan Drugs Act (USA)

ODD

Orphan drug designation

OIA

Official action indicated

OOS

Out of specification

OPD

Original pack dispensing

OTC

Over-the-counter

P

P&R

Pricing and reimbursement

P

Pharmacy only

P to GSL

Pharmacy to General Sales List

PA

Product authorization

PAI

Pre-approval inspection

PAR

Preliminary assessment report

PASS

Post authorisation safety study

PAT

Process analytical technology

PCT

Primary care trust

PDE

Personal daily exposure

PER

Pharmaceutical evaluation report

PGD

Patient group direction

PI

Prescribing information

PI

Production information

PIL

Patient information leaflet

PIM

Product information management (EMA)

PIP

Paediatric investigation plan

PMS study

Post-marketing safety study

PMS

Postmarket(ing) surveillance

POM

Prescription-only medicine

POM to P

Prescription-only medicine to pharmacy

PPI

Patient and Public Involvement (UK)

PRAC

Pharmacovigilance Risk Assessment Committee

PRSPH

Potential serious risk to public health

PSMF

Pharmacovigilance system master file

PTE

Patent term extension

PUMA

Paediatric-use marketing authorization

PV

Pharmacovigilance

PVAR

Preliminary Variation Assessment Report

Q

QA

Quality assurance

QbD

Quality by design

QC

Quality control

QMS

Quality management system

QOL

Quality of life

QoS

Quality overall summary

QP

Qualified person

QPPV

Qualified person for pharmacovigilance

QRD

Quality review of documents

R

RA

Regulatory affairs

RCFID

Registration Certificate for Import of Drug

RCT

Randomised controlled trial

RDE

Remote data entry

RDS

Repeat dose study

RDT

Rising-dose tolerance

REACH

Registration, evaluation, authorisation and restriction of chemicals

RI

Regulatory intelligence

RING

Regulatory Intelligence Network Group

rINN

Recommended international non-proprietary name

RMM

Risk minimisation measure

RMP

Reference medicinal product

RMR

Reaction monitoring report

RMS

Reference Member State

ROI

Return on investment

RoW

Rest of world

RP

Responsible person

RPS

Regulated product submission

Rx

Prescription

S

S+T

Sampling and testing

SAG

Scientific Advisory Group

SAP

Scientific advice procedure

SAWP

Scientific Advice Working Party

SI

Statutory instrument

SLA

Service level agreement

SME

Significant medical event

SMF

Site master file

SMO

Site management organization

SMQ

Standardised MedDRA query

SOP

Standard operating procedure

SPIN

Special interest network

SSC

Scientific Steering Committee

SWOTs

Strengths – weaknesses – opportunities – threats

T

TAG

Therapeutic Advisory Group

TLV

Threshold limit value

TOC

Table of contents

TOD

Table of decisions

TOPRA

The Organisation for Professionals in Regulatory Affairs

TPP

Target product profile

TSE

Transmissible Spongiform Encephalopathy

U

USP

United States Pharmacopeia

V

VAMF

Vaccine antigen master file

VAI

Voluntary action indicated

W

WC

Written confirmation

WHO

World Health Organization

WL

Wholesale dealer’s licence

WRAC

Worldwide Regulatory Affairs Committee