Introduction to Drug Safety & Pharmacovigilance Regulations in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods. Contact: "Katalyst Healthcares & Life Sciences" South Plainfield, NJ, USA info@KatalystHLS.com

1. 1
Regulatory Guidelines And
Laws Governing Pharmacovigilance
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2. FDA EMEA MHRA
MHLW
and
PMDA
CDSCO
Who regulates Drug Safety:
 Assess safety warnings
 Labeling change
 Withdrawal
Regulatory Agencies:
HEALTH
CANADA
TGA
(Therape
utic
Goods
Administr
ation)
Australia Canada
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3. The US FDA is a scientific, regulatory, and public health agency.
MedWatch is the FDA’s reporting system for adverse events. Healthcare professionals, Consumers,
and Patients can report Voluntarily. Reporting can be conducted online, by phone, by submitting
the MedWatch 3500 Form.
US FDA
Mandatory
Voluntary
MedWatch 3500 A MedWatch 3500
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4. EMA:
 The pharmacovigilance effort in Europe is coordinated by the European Medicines Agency
(EMA) and conducted by the national competent medicines authorities (NCA)
 The main responsibility of the EMA is to maintain and develop the pharmacovigilance
database consisting of all suspected serious adverse reactions to medicines observed in
the European Community. The system is called EudraVigilance (European Union Drug
Regulating Authorities Pharmacovigilance) and contains separate but similar databases of
human and veterinary reactions
 EudraLex is the collection of rules and regulations governing medicinal products in the
European Union
 EudraLex consists of 10 volumes
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5. – European (European Medicines Agency; EMA)
– Post-marketing: Regulation (EC) No 726/2004 will be amended by Regulation
1245/2010 – July 2012; Directive 2001/83/EC will be amended by Directive
2010/84/EU – July 2012; guidance - Volume 9a
– Clinical trials: Directive 2001/20/EC; guidance - Volume 10
– US (Food and Drug Administration; FDA)
– Post-marketing: Code of Federal Regulations 21CFR 310.305, 314.80 and 314.98
– Clinical trials: Code of Federal Regulations 21CFR 312.32
– Japanese (Ministry of Health, Labour, Welfare; MHLW / Pharmaceuticals and Medical
Devices Agency (PMDA))
– Ministerial Ordinances and Notifications.
Legislations: 5
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6. EudraLex 10 volumes
 Concerning Medicinal Products for Human use:
 Volume 1 - Pharmaceutical Legislation
 Volume 2 (A, B, C) - Notice to Applicants
 Volume 3 – Guidelines
 Volume 9a - "Rules Governing Medicinal Products in the European Union: Pharmacovigilance
for medicinal products for human use".
 Concerning Medicinal Products for Human and Veterinary use:
 Volume 4 - Good Manufacturing Practices
 Volume 9 – Pharmacovigilance guidelines (9a, 9b)
 Concerning Medicinal Products for human use in clinical trials
(investigational medicinal products).
 Volume 10 - Clinical Trials
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7. The Medicines and Healthcare products Regulatory Agency (MHRA) ensures that medicines
and medical devices are acceptably safe.
Yellow Card Scheme
Both patients and healthcare professionals are encouraged to report all suspected adverse drug reaction.
UK - MHRA 7
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8. India – CDSCO (NPP):
The National Pharmacovigilance Program (NPP) is coordinated at Central
Drug Standard Control Organization (CDSCO) office
Aims:
 Monitor ADRs
 Review PSURs
 Recommendations regarding label, amendments & withdrawal
 Liaise with international regulatory bodies working on PV
 Provide information through bulletins, drug alerts and seminars
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9.  International activities in field of biomedical sciences
 Scientific interests of the international biomedical community.
CIOMS:
The Council for International Organizations of Medical Sciences (CIOMS) is an international,
non-governmental, non-profit organization. Established jointly by WHO and UNESCO.
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10. 10
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11. 11
Thank You
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Contact:
Katalyst Healthcare’s & Life Sciences
South Plainfield, NJ, USA 07080.
E-Mail: info@KatalystHLS.com