Utilities

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Acronyms

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TERM

COUNTRY

DEFINITION

AADA

Int

Abbreviated Antibiotic Drug Application

AAPS

US

American Association of   Pharmaceutical Scientists

ABC

US

American Botanical Council

ABPI

UK

Association of British   Pharmaceutical Industries

ACSI

US

American Customer Satisfaction Index

ADME

Int

Absorption, Distribution,   Metabolism, and Excretion

ADR

Int

Adverse Drug Reaction

AF

Int

Application Form

AFI

IT

Associazione Farmaceutici Industria

AFSSPS

FR

Agence Francaise de Securite Sanitaire des Produits   de Sante

AIC

IT

Autorizzazione Immissione in Commercio

AICQ

IT

Associazione Italiana per la Qualità

AICRC

UK

Association of Independent   Clinical Research Contractors

AIFA

IT

Agenzia Italiana del Farmaco

AMG

DE

Arzneimittelgesetz (German Drug Law)

ANDA

US

Abbreviated New Drug Application

ANDS

Int

Abbreviated New Drug Submission

AO

IT

Azienda Ospedaliera

API

Int

Active Pharmaceutical Ingredients

ASL

IT

Azienda Sanitaria Locale

AR

Int

Assessment Report

ASMF

Int

Active Substance Master Files

BAPP

UK

British Association of   Pharmaceutical Physicians

BfArM

DE

Bundesinstitut für   Arzneimittel und Medizinprodukte (German: Federal Institute for Drugs and   Medical Devices

BLA

Int

Biologics License Application

BP

UK

British Pharmacopoeia

BPD

Int

Biocidal Products Directive

BPL

IT

Buona Pratica Laboratorio

BSE

Int

Bovine Spongiform Encephalopathy

CAPRA

CND

Canadian Association of   Pharmaceutical Regulatory Affairs

CAT

Int

Committee for Advanced Therapies

CAS Number

Int

Chemical Abstracts Service Number

CBER

US

Center for Biologics   Evaluation and Research

CDC

US

Centers for Disease Control

CDER

US

Center for Drug Evaluation   and Research

CDRH

US

Center for Devices and   Radiological Health

CE

IT

Consiglio Europeo

CEN

Int

Comité Européen de Normalisation

CEP

Int

Certificate European Pharmacopoeia

CES

IT

Comitato Economico e Sociale

CHMP

Int

Committee for Medicinal   Products for Human Use

CIOMS

Int

Council for International   Organizations of Medical Sciences

CIPE

IT

Comitato Interministeriale per la Programmazione Economica

CLP regulation

Int

Classification, Labelling   and Packaging Regulation

CLV

IT

Certificato di Libera Vendita

CMC

US

Chemistry, Manufacturing, and Controls

CMD(h)

Int

Co-ordination Group for   Mutual Recognition and Decentralised Procedures – Human

CMD(v)

Int

Co-ordination Group for   Mutual Recognition and Decentralised Procedures – Veterinary

CMS

Int

Concerned Member State

CND

IT

Classificazione Nazionale dei Dispositivi Medici

COLIPA

Int

Comité de Liaison des Associations Européennes de   LIndustrie de la Parfumerie, des Produits Cosmetiques et de Toilette

COMP

Int

Committee for Orphan   Medicine Product

COPR

Int

Control of Pesticides Regulations

CoS

Int

Certificate of Suitability

CP

Int

Centralized Procedure

CPP

IT

Certificato di Prodotto Farmaceutico

CRC

Int

Clinical Research Coordinator

CRO

Int

Contract Research Organisation

CSD

UK

Committee on Safety of   Medicines

CSR

Int

Clinical Study Report

CSS

IT

Consiglio Superiore di Sanità

CTD

Int

Common Technical Dossier

CTC

UK

Clinical Trial Certificate

CTS

IT

Commissione Tecnico Scientifica

CTX

UK

Clinical Trial Exemption

CUF

IT

Commissione Unica del Farmaco

CVMP

Int

Committee for Medicinal Products for Veterinary Use

DCP

Int

Decentralised Procedure

DD

Int

Due Diligence

DDD

Int

Dear Doctor Letter

DDD

Int

Define Daily Dose/ Dose Define Die

DdL

IT

Disegno di Legge

DL

IT

Decreto Legge

D.Lgs.

IT

Decreto Legislativo

D.M.

IT

Decreto Ministeriale

DM

IT

Dispositivo Medico

DMF

Int

Drug Master File

DPI

IT

Dispositivi per la Protezione Individuale

DRG

Int

Diagnosis Related Groups

DDPS

Detailed Description Pharmacovigilance System

ECHA

Int

European Chemical Agency

ECM

IT

Educazione Continua in Medicina

eCTD

Int

electronic Common Technical Dossier

EDQM

Int

European Directorate for the Quality of Medicines   & HealthCare

EEA

Int

European Economic Area

EFPIA

Int

European Federation of the Pharmaceutical Industries   and Associations

EFQM

Int

European Foundation for Quality Management

EFSA

Int

European Food Safety Authority

EFTA

Int

European Free Trade Association

EGA

Int

European Generic medicines Association

EINECS

Int

European Inventory of   Existing Commercial Chemical Substances

EMA

Int

European Medicine Agency

EOQ

Int

European Organization for Quality

EPAR

Int

European Public Assessment Report

EPO

Int

European Patent Organisation

ESTRI

Int

Electronic Standards for the   Transmission of Regulatory Information

ETOMEP

Int

European Technical Office   for Medicinal Products

EUCOMED

Int

European Confederation of   Medical Devices Association

EUDRA

Int

European Union Drug   Regulatory Authorities

EVCTM

Int

EudraVigilance Clinical Trial Module

EVDAS

Int

EudraVigilance Data   warehouse Analysis System

FANS

IT

Farmaci Anti-infiammatori non Steroidei

FDA

US

Food and Drug Administration

FMEA

Int

Failure Mode and Effects   Analysis

FSC

Int

Free Sale Certificate

FU

IT

Farmacopea Ufficiale

GCP

Int

Good Clinical Practice

GDP

Int

Good Distribution Practice

GHS

Int

Globally Harmonised System

GHTS

Int

Global Harmonisation Task Force

GLP

Int

Good Laboratory Practice

GMDN

Int

Global Medical Device Nomenclature

GMP

Int

Good Manufacturing Practice

GPvP

Int

Good Pharmacovigilance Practise

GVP

Int

Good Vigilance Practises

GU

IT

Gazzetta Ufficiale

HACCP

Int

Hazard Analysis Critical   Control Point

HMA

Int

Heads of Medicines Agency

HMPC

Int

Committee on Herbal   Medicinal Products

HPFB

Int

Health Products and Food   Branch

HPLC

Int

High-performance liquid chromatography

HSE

UK

Healthy Survey for England

ICDRA

Int

International Conference of   Drug Regulatory Authorities

ICH

Int

International Conference on Harmonisation

ICSR

Int

Individual Case Safety Report

IDE

US

Investigational Device Exemption

IFPMA

Int

International Federation of   Pharmaceutical Manufacturers & Associations

IfU

Int

Istruction for Use

INCI

Int

International Nomenclature   of Cosmetic Ingredients

IND

US

Investigational New Drug Application

IRD

Int

Initial Receipt Dates

ISBN

Int

International Standard Book Number

ISO

Int

International Organization for Standardization

ISPRA

IT

Istituto Superiore per la Protezione e la Ricerca   Ambientale

ISS

IT

Istituto Superiore di Sanità

ISTAT

IT

Istituto Nazionale di Statistica

IUCLID

Int

International Uniform   Chemical Information Database

IUPAC

Int

International Union of Pure   and Applied Chemistry

IVD

Int

In Vivo Diagnostic

JPMA

Int

Japan Pharmaceutical Manufacturers Association

LARN

IT

Livelli di Assunzione giornalieri Raccomandati di   energia e Nutrienti

LoA

Int

Letter of Access

MA

Int

Marketing Authorization

MAA

Int

Marketing Authorization Application

MAH

Int

Marketing Authorization Holder

MBTC

Int

Management Board Telematics Committee

MCA

UK

Medicines Control Agency

MD

Int

Medical Device

MDMA

US

Medical Device Manufacturers Association

MdS – MinSal

IT

Ministero della Salute

MedDRA

Int

Medical Dictionary for Drug   Regulatory Affairs

MHRA

UK

Medicines and Healthcare   Products Regulatory Agency

MIUR

IT

Ministero dell’Istruzione, dell’Università e della   Ricerca

MND

SGP

Ministry of National Development

MRP

Int

Mutual Recognition Procedure

NAS

IT

Nucleo Antisofisticazione e Sanità

NAS

Int

New Active Substance

NB

Int

Notified Body

NBF

IT

Norme di Buona Fabbricazione

NCA

UK

National Competent Authority

NCI

US

National Cancer Institute

NCNPR

Int

National Center Natural Products   Research

NDA

US

New Drug Application

NDS

Int

New Drug Submission

NIH

Int

National Institutes of Health

NOIS

IT

Nulla Osta Igienico Sanitario

NPA

UK

National Pharmaceutical Association

OD

Int

Orphan Drug

NSAID

Int

Nonsteroidal Anti-inflammatory Drug

OGD

US

Office of Generic Drugs

OGM

IT

Organismo Geneticamente Modificato

OMCL

Int

Official Medicines Control Laboratories

OMS

IT

Organizzazione Mondiale della Sanità

OTC

Int

Over the Counter

PAT

Int

Process Analytical Technology

PDCO

Int

Pediatric Committee

PHT

IT

Prontuario ospedale-territorio

PhVWP

Int

Pharmacovigilance Working Party

PICS

FR

Programmes Internationaux de Coopération   Scientifique

PICS

Int

Pharmaceutical Inspection Cooperation Scheme

PIL

Int

Product Information Label

PIM

Int

Product Information Management

PIP

Int

Pediatric Investigation Plan

PMA

US

Pre-market Authorization for   approval of class III devices

PMC

IT

Presidio Medico Chirurgico

PMI

IT

Piccole e Medie Imprese

PRR

Int

Proportional Reporting Ratio

PRAC

Pharmacovigilance Risk Assessement Committee

PSMF

Int

Pharmacovigilance Sistem Master File

PSUR

Int

Product Safety Update Report

PVAR

Int

Preliminary Variation Assesment Report

RMS

Int

Reference Member State

QA

Int

Quality Assurance

QC

Int

Quality Control

QOS

Int

Quality Overall Summary

QP

Int

Qualified Person

QPPV

Int

Qualified Person Pharmacovigilance

QRD

Int

Quality Review of Documents

RAEE

IT

Rifiuti di Apparecchiature Elettriche ed   Elettroniche

RAPEX

Int

Rapid Exchange about Safety   Product

RAPS

Int

Regulatory Affairs Professionals Society

RCP

IT

Riassunto delle Caratteristiche del Prodotto

RDA

Int

Recommended Daily Allowance

REACH

Int

Registration, Evaluation,   Authorisation and Restriction of Chemicals

R&D

Int

Research and Development

RMP

Int

Risk Management Plan

RPSGB

UK

Royal Pharmaceutical Society   of Great Britain

SAE

Int

Serious Adverse Event

SAG

Int

Scientific Advisory Group

SCI

IT

Società Chimica Italiana

SDRs

Int

Signals Disproportionate Reporting

SMF

Int

Site Master File

SME

Int

Small and Medium-sized   Enterprise

SOP

US

Standard Operating Procedure

SOP

IT

Senza Obbligo di Prescrizione

SIAF

IT

Sistema Informatico Anagrafe Fondi

SIAR

IT

Società Italiana Attività Regolatorie

SPC

Int

Summary of Product Characteristics

SSN

IT

Servizio Sanitario Nazionale

SUSAR

Int

Suspected, Unexpected,   Serious Adverse Reaction

THR

Int

Traditional Herbal Registration

THRMS

Int

Traditional Herbal Medicines   Registration Scheme

TNG

Int

Technical Note for Guidance

ToC

Int

Table of Contents

TOPRA

Int

The Association for   Regulatory Affairs Professionals

TRACS

US

Transit Rail Advisory   Committee for Safety

TSE0

Int

Transmissible Spongiform Encephalopathy

USAN

US

United States Adopted Names

USP

US

United States Pharmacopeia

USR

Int

Urgent Safety Restriction

VAMF

Int

Vaccine Antigen Master File

WHO

Int

World Health Organisation