Pharmacovigilance Regulations - Katalyst HLS
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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
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Pharmacovigilance Regulations - Katalyst HLS
- 1. 1 Regulatory Guidelines And Laws Governing Pharmacovigilance 1/10/201 7 Katalyst Healthcares & Life Sciences
- 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 2 1/10/2017Katalyst Healthcares & Life Sciences
- 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 3 1/10/201 7 Katalyst Healthcares & Life Sciences
- 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 4 1/10/2017Katalyst Healthcares & Life Sciences
- 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 1/10/2017Katalyst Healthcares & Life Sciences
- 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 6 1/10/2017Katalyst Healthcares & Life Sciences
- 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 1/10/201 7 Katalyst Healthcares & Life Sciences
- 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 8 1/10/201 7 Katalyst Healthcares & Life Sciences
- 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. 9
- 10. 10 1/10/201 7 Katalyst Healthcares & Life Sciences
- 11. 11 Thank You 1/10/201 7 Contact: Katalyst Healthcare’s & Life Sciences South Plainfield, NJ, USA 07080. E-Mail: info@KatalystHLS.com
Editor's Notes
- The U S. Food and Drug Administration is a scientific, regulatory, and public health agency that oversees items accounting for 25 cents of every dollar spent by consumers. Its jurisdiction encompasses most food products (other than meat and poultry), human and animal drugs, therapeutic agents of biological origin, medical devices . The agency grew from a single chemist in the U.S. Department of Agriculture in 1862 to a staff of approximately 9,100 employees and a budget of $1.294 billion in 2001, comprising chemists, pharmacologists, physicians, microbiologists, veterinarians, pharmacists, lawyers, and many others. Mission Is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
- The MHRA collects information from both health professionals and patients on suspected adverse drug reactions and suspected defects in medicinal products. Mission: to keep watch over medicines and devices, and necessary action to protect the public promptly if there is a problem. to make as much information as possible publicly available. to enable greater access to products, and the timely introduction of innovative treatments and technologies that benefit patients and the public. to encourage everyone - the public and healthcare professionals as well as industry - to inform about any problems with a medicine or medical device, so that it can investigate and take any necessary action. MHRA operates site http://yellowcard.mhra.gov.uk/ for reporting of adverse drug reactions Reporting by post is also possible Both patients and healthcare professionals are encouraged to report all suspected adverse drug reaction. MHRA evaluates whether risk is serious and whether there is a causality. Pharmacies are encouraged to display poster on YellowCard and mention it to patients who may experience ADRs when giving advice. MHRA provides yellow card to patients (distributed also thru pharmacies) with information on reporting. Pharmacists are considered to be crucial in informing patients on ADRs reporting
- The Central Drugs Standard Control Organization (CDSCO) has initiated a country-wide Pharmacovigilance programme under the aegis of DGHS, Ministry of Health & Family Welfare, Government of India. The programme is coordinated by the National Pharmacovigilance Centre at CDSCO. The National Centre is operating under the supervision of the National Pharmacovigilance Advisory Committee to recommend procedures and guidelines for regulatory interventions.
- WHO organization - 1949 Drug Safety Working Group: industry, regulators, academia Four publications over past decade No regulatory status Really a “think tank” on issues of importance to international pharmacovigilance community Identify significant issues and offer pragmatic solutions The Council for International Organizations of Medical Sciences (CIOMS) is an international, non-governmental, non-profit organization established jointly by WHO and UNESCO in 1949. Through its membership, CIOMS is representative of a substantial proportion of the biomedical scientific community. The membership of CIOMS in 2003 includes 48 international member organizations, representing many of the biomedical disciplines, and 18 national members mainly representing national academies of sciences and medical research councils. UNESCO - the United Nations Educational, Scientific and Cultural Organization (UNESCO) was founded on 16 November 1945. For this specialized United Nations agency, it is not enough to build classrooms in devastated countries or to publish scientific breakthroughs. Education, Social and Natural Science, Culture and Communication are the means to a far more ambitious goal : to build peace in the minds of men.