pharmacovigilance regulations - katalyst hls

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Regulatory Guidelines And Laws Governing Pharmacovigilance

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Katalyst Healthcares & Life Sciences

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FDA EMEA MHRAMHLW

and PMDA

CDSCO

Who regulates Drug Safety:

Assess safety warnings

Labeling change Withdrawal

Regulatory Agencies:

HEALTH CANADA

TGA (Therapeutic Goods Administratio

n)

Australia

Canada

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3The 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

MandatoryVoluntary

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:

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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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7The Medicines and Healthcare products Regulatory Agency (MHRA) ensures that medicines and medical devices are acceptably safe.

Yellow Card SchemeBoth patients and healthcare professionals are encouraged to report all suspected adverse drug reaction.

UK - MHRA

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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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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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ADR Form in INDIA

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Thank You

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Contact:Katalyst Healthcare’s & Life SciencesSouth Plainfield, NJ, USA 07080.E-Mail: [email protected]

mailto:[email protected]

pharmacovigilance regulations - katalyst hls

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