Adverse Drug Reaction (ADR) reporting systems are crucial components of pharmacovigilance activities worldwide. They facilitate the collection, analysis, and monitoring of adverse events associated with the use of medications. Here are some notable global ADR reporting systems: VigiBase (World Health Organization - WHO): VigiBase is the global database managed by the Uppsala Monitoring Centre (UMC), a WHO collaborating center for international drug monitoring. It receives ADR reports from national pharmacovigilance centers in over 130 countries. VigiBase serves as a central repository of ADR data, allowing for signal detection, analysis, and monitoring of drug safety on a global scale. MedWatch (United States - US FDA): MedWatch is the FDA's ADR reporting system in the United States. It allows healthcare professionals, consumers, and manufacturers to voluntarily report adverse events and product problems associated with FDA-regulated drugs, biologics, medical devices, and dietary supplements. The system provides a platform for collecting and analyzing safety information to support regulatory decisions. Yellow Card Scheme (United Kingdom - MHRA): The Yellow Card Scheme is the ADR reporting system in the United Kingdom, managed by the Medicines and Healthcare products Regulatory Agency (MHRA). It enables healthcare professionals and the public to report suspected ADRs associated with medicines, vaccines, and medical devices. The data collected through the scheme contribute to the ongoing monitoring of drug safety in the UK. EudraVigilance (European Medicines Agency - EMA): EudraVigilance is the European Union's centralized database for the collection and management of ADR reports. It receives reports from national competent authorities, marketing authorization holders, and other stakeholders across the EU member states. EudraVigilance supports the monitoring and evaluation of the safety of medicinal products in the European market. TGA Adverse Event Management System (Australia - TGA): The Therapeutic Goods Administration (TGA) in Australia operates the Adverse Event Management System (AEMS), which allows healthcare professionals, consumers, and industry representatives to report suspected ADRs associated with medicines, vaccines, and medical devices. AEMS supports the TGA's monitoring and evaluation of product safety in Australia. CIOMS (Council for International Organizations of Medical Sciences) Reporting System: The CIOMS reporting system is a global initiative that encourages the reporting of ADRs directly to national pharmacovigilance centers or regional drug safety databases. It provides a standardized format for ADR reporting, facilitating the exchange of safety information among participating countries and organizations.

1. Welcome
Global ADR Reporting Systems
SHIFY ROSS
Pharm-D
Student ID: CSRPL_INT_OFL_WKD_135/0722
shifyross8@gmail.com
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 With the use of any medication, possibility of unwanted consequences are more.
 According to the Centre for Health Policy Research, in 1998, more than 50% of approved drugs in the US
were associated with some type of adverse effect not detected prior to approval.
 Various studies in the US have identified adverse drug reactions (ADRs) as between the fourth and sixth
leading cause of death (higher than motor vehicle accidents, breast cancer or AIDS)
 Voluntary reporting of ADRs by health professionals are the basic foundation of the management of ADRs
in any healthcare system.
 In different countries like US,UK, Canada, New Zealand, there have been developed formal
reporting systems by which health professionals and, in some countries consumers can report ADRs.
Global ADR Reporting Systems
INTRODUCTION:
The ADR reporting in some countries are listed as follows

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ADR reporting in the UK
Reporters Reportable events Reporting systems Reporting analysis and
feedback mechanism
Reports/
year
(approx)
Doctors,
dentists,
pharmacists,
coroners,
nurses
All suspected ADRs
associated with
recently or newly
marketed
medicines, including
unlicensed herbal
medicines All
reactions to new
drugs (‘black
triangle’). Serious
reactions to
established drugs
Paper ‘yellow card’
(available via British
National Formulary
(BNF), ABPI
Compendium of Data
Sheets and Summaries
of Product
Characteristics, MIMS
Companion and
CSM/MCA website)
Electronic ‘yellow card’
(since 31 October 2002,
via CSM/MCA website)
All reported ADRs are
entered onto MCA’s
Adverse Drug
Reactions Online
Information Tracking
(ADROIT) database.
MCA’s Post Licensing
Division takes report
analysis and necessary
actions
18 000
: ADR reporting in the UK is via the ‘yellow card’. This spontaneous
reporting scheme was launched in 1964,2,19 and is currently run by
the Medicines and Healthcare Products Regulatory Agency (MHRA).

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Reporters Organisation Reportable events Reporting
systems
Reporting
analysis and
feedback
mechanism
GPs,
specialists,
pharmacists
Lareb
(Netherlands
Pharmacovigila
nce
Foundation)
Any suspected adverse reaction and the
following
. all side-effects and reactions caused by
new prescription medicines . serious side
effects . effects which result in hospital
admission, work incapacity or death .
suspected interactions with other
medications . side effects of vaccines, self-
administered medication or alternative
therapies
Reporting form
printed inside
the Dutch
equivalent of
the National
Formulary
Systemic
review of all
reports by a
team of
experts
ADR reporting in The Netherlands : A spontaneous ADR reporting scheme started in the
Netherlands in 1963, and pharmacists have been involved
in this reporting scheme since its inception

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ADR Reporting in the USA
System Organisation Reportable events Reporters Recipients of information
from analysis
Reports/
year
Medication Error
Reporting
Program
Institute for Safe
Medication
Practices (ISMP)
and United States
Pharmacopeia
Adverse drug events; drug
reactions; medication errors;
drug name, labelling and
packaging hazards
Primarily
pharmacies,
but open to
all
Hospitals, pharmacists,
Food and Drug
Administration (FDA),
pharmaceutical companies,
all interested parties
1000
MedMARx United States
Pharmacopeia (USP)
Medication errors Hospitals Hospitals 6000
National
Nosocomial
Infection Survey
Center for Disease
Control
Hospital-acquired infections Participating
hospitals
Participating hospitals 40 000
Sentinel Events
Reporting
Program
Joint Commission on
Accreditation of
Healthcare Organisations
(JCAHO)
Serious injuries, accidental
deaths
Hospitals Hospitals 300 –500
MedWatch FDA Adverse events of medical products
including prescription and OTC drugs,
biologics, medical and radiation
emitting devices and special
nutritional products
Voluntary for
health
professionals
and
consumers
All concerned
: Two types of ADR reporting exist in the US: External and Internal.

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ADR reporting in Canada
Reporters Organisation Reportable events Reporting systems Reporting analysis
and feedback
mechanism
Physicians,
pharmacists
and other
health
professionals
Canadian Adverse
Drug Reaction
Monitoring
Program
(CADRMP)
All suspected ADRs
which are
unexpected,
regardless of their
severity; serious,
whether expected or
not; reactions to
recently marketed
drugs
Using the ADR reporting form
to report suspected adverse
reaction due to drug products
marketed in Canada (vaccines
excluded). The form is available
from national and regional ADR
centres and is included in the
Compendium of
Pharmaceuticals and
Specialities (CPS)
Systemic review of
all reports by a
team of experts
Physicians,
pharmacists
and other
health
professionals
Laboratory
Centre for
Disease Control
All suspected ADRs
for vaccines
Using vaccine-associated
adverse event form. This form
is included in the CPS
: ADR reporting is considered one of the essential components of post
marketing surveillance in Canada. The Canadian Adverse Drug Reaction
Monitoring Program(CADRMP) monitors the ADR reporting scheme for drug
products

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ADR reporting in New Zealand
Reporters Organisation Reportable events Reporting systems Reporting analysis
and feedback
mechanism
Doctors,
pharmacists
nurses
CARM (Centre
for Adverse
Drug
Reactions
Monitoring)
• Any suspect reactions of
clinical concern to all
medicines, vaccines,
OTC medicines, herbal,
traditional and
alternative remedies,
and events to IMMP
Medicines
• Adverse reactions and
interactions that are
serious and adverse
reaction of current
concern
• Yellow reporting form
(available via
Prescribers’ Update,
New Ethicals
• Catalogue and online
from the CARM
website)
Electronic/online
reporting via CARM
website)
• CARM undertakes regular
analysis of the database
to determine significant
patterns of adverse
reactions, resulting in the
suggestion to change
prescribing advice
• Individual patients receive
warning or danger alerts
against their ‘unique
National Health Index
number’ for severe or lifethreatening
reactions
Doctors,
pharmacists
nurses
IMMP (The
Intensive
Medicines
Monitoring
Program)
All adverse reactions to
new medications and all
events to IMMP
medications
Prescription Event
Monitoring (PEM)
form (IMMP
Prescription Form)
and Electronic/online
reporting, via CARM
website)
• Undertakes ‘‘prospective,
observational, cohort
studies on selected new
medicines’’
• The results are reported to
the Ministry of Health
and health professionals
IMMP supplements the
ADR database
: The Centre for Adverse Drug Reactions Monitoring (CARM)
programme monitors adverse drug reactions in New Zealand

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ADR reporting in Singapore
Reporters Organisation Reportable events Reporting systems Reporting analysis and
feedback mechanism
Physicians,
dentists,
pharmacists
Pharmacovigilance
(PV) Unit, the
Centre for
Pharmaceutical
Administration
All ADRs related to
pharmaceutical
medicines (as defined
by the WHO). Also
accepts reports
associated with
Chinese proprietary
medicines and herbal
remedies
Using the ADR
reporting form via
telephone, mail, fax,
email and
electronically
through the
internet. Form can
also be found in the
MIMS Singapore
All reports are individually
analysed with particular
attention to the serious
ADRs. The reporter is
informed if he/she ‘‘ticked
the box on the form to
request information about
other reports associated
with the suspected drug’’
:The Pharmacovigilance Unit (PV Unit) at the Centre for
Pharmaceutical Administration, Singapore, is responsible
for ADR report monitoring, and has been in operation
since 1993

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ADR reporting in Australia
Reporters Organisation Reportable events Reporting systems Reporting analysis and
feedback mechanism
Anyone:
physicians,
pharmacists,
other
health
professionals,
consumers,
pharmaceutical
companies
ADRAC at the
Therapeutic
Drug
Administration
(TGA)
All suspected ADRs
on prescription
medicines,
vaccines, OTC
medicines and
complementary
medicines
Using the ‘blue card’
reporting form.
This form is
available at the
TGA website (for
online reporting
and in electronic
printable format),
the ADRU,
Australian Adverse
Drug Reaction
Bulletin and as a
lift-out at the front
of the Schedules of
Pharmaceutical
Benefits (sent to all
doctors, dentists
and pharmacists
four times each
year)
All reports received are
assessed by health
professionals and
entered into the
Australian Drug
Reactions System
(ADRS). All serious
ADRs, reports for
vaccines and
complementary
medicines (serious
and non-serious) are
forwarded to
ADRAC for further
assessment and
relevant actions (e.g.
generate signals,
recommendation to
remove medicine
from the market)
: The Adverse Drug Reactions Unit (ADRU), within the Therapeutic Goods
Administration (TGA), co-ordinates ADR reporting in Australia.

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ADR reporting in Sweden
Reporters Organisation Reportable events Reporting systems Reporting analysis and
feedback mechanism
Mandatory for
prescribers;
other sources
Industry and
industry
publications,
government
bodies, WHO
Medical Products
Agency (MPA)
All serious or
unexpected adverse
reactions which
appear to increase in
frequency shall be
reported. For new
products, all
suspected adverse
reactions excluding
those included in the
summary of product
characteristics are to
be reported
The MPA form can be
used with advantage
and supplemented
with relevant extracts
from case analyses,
patient records,
laboratory results.
Reports can be sent
directly to MPA or
the regional
pharmacovigilance
centres of the MPA
MPA undertakes risk/
benefit analysis,
information and alerts,
withdrawals etc. MPA
further transfers the
ADRs concerning
centrally approved
medicinal products to
the European Agency
for the Evaluation of
Medicinal Products
(EMEA). EMEA
provides information
to health care
professionals
: In Sweden, ADRs are reported from National Healthcare
and hospitals by prescribers, via seven regional adverse
drug reaction centres to the Medical Products Agency
(MPA).

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References:
https://www.researchgate.net/publication/43451200
https://www.researchgate.net/publication/43451200_An_introduction_to_adverse_d
rug_reaction_reporting_systems_in_different_countries

12. Thank You!
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SHIFY ROSS
Pharm-D
Student ID: CSRPL_INT_OFL_WKD_135/0722
shifyross8@gmail.com