A NEW ERA OF DRUG SAFETY – NEW EU PHARMACOVIGILANCE (PV) LEGISLATION AND COMPARISON OF PV IN EU, US AND INDIA


Atul Khurana, Rajul Rastogi, Hans-joachim Gamperl

Abstract


A series of public health disasters (Thalidomide in the 1960s to Rofecoxib (Vioxx) at the beginning of this century have served to remind us that effective Pharmacovigilance (PV) is crucial for protection of citizens. The introduction of new PV legislation in July 2012 is the biggest change to the regulation of human medicines in the European Union (EU) since 1995. New requirements and procedures for Post-Authorization Safety Studies (PASS) open the gateway for development of real-world effectiveness outcomes. Similarly, the United States Food and Drug Administration (USFDA) has become more open to inclusion of non-safety data collection in its safety surveillance mandates and more proactive risk management approach. In addition, the Marketing Authorisation Holders (MAHs) need to be more efficient with their post-authorisation activities to maximize their utility. The main goal of this new PV path is to strengthen the public health. However it is also concerned with improved efficiency, clear decision-making processes, reduce duplication and better use of Information Technology in PV process.

Keywords: Pharmacovigilance, European Medicine Agency, Good Pharmacovigilance practice, New EU PV Legislation, Food and Drug Administration, Signal detection, Risk Management Plan.

 


Keywords


Pharmacovigilance, European Medicine Agency, Good Pharmacovigilance practice, New EU PV Legislation, Food and Drug Administration, Signal detection, Risk Management Plan.

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References


J. Commission Staff Working Document. J European Communities 2008;9:52

Wiktorowicz M, Lexchin J, Moscou K. Pharmacovigilance in Europe and North America: divergent approaches. Soc Sci Med. 2012 Jul; 75(1): 165-170.

WHO Policy Perspectives on Medicines Pharmacovigilance: Ensuring the Safe Use of Medicines. J WHO Geneva, Switzerland 2004.

Directive 2010/84/EU of the European Parliament and of the Council of December 15, 2010 (2010). Official Journal of the European Union 378: 74-99.

Regulation (EU) No 1235/2010 of the European Parliament and of the Council of December 15, 2010 (2010). Official Journal of the European Union 348: 1-16.

Guideline on good pharmacovigilance practices (GVP), Annex I-Definitions.

Businaro R. Why We Need an Efficient and Careful Pharmacovigilance? J Pharmacovigilance 2013, 1:4.

European Medicines Agency and Heads of Medicines Agencies. Guideline on Good Pharmacovigilance Practices (GVP), http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document%20listing_000345.jsp.

Implementing the pharmacovigilance legislation: focus on EU level activities, http:// www. ema.europa. eu/ docs/en_GB/ document_library/Presentation/2013/10/WC500151650.pdf.

The new EU pharmacovigilance legislation: Directive 2010/84/EU and Regulation No. 1235/2010. Guidance for Patient Organisations, http://www.eu-patient.eu/ Documents/ Policy/PharmaceuticalPackage/EPF%20Guidance%20Pharmacovigilance%20for%20Patient%20Organisations.pdf.

Pharmacovigilance Risk Assessment Committee - Rules of Procedure,http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/03/WC500139609.pdf.

Arlett P, Portier G, de Lisa R, Blake K, Wathion N, Dogne J-M, et al. Proactively managing the risk of marketed drugs:experience with the EMA Pharmacovigilance Risk Assessment Committee. J Nature reviews Drug discovery 2014;13(5):395-7.

Guideline on good pharmacovigilance practices (GVP) Module II – Pharmacovigilance system master file, http:// www.ema. europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129133.pdf.

Guideline on good pharmacovigilance practices (GVP) Module V – Risk management systems, http:// www.ema.europa.eu/ docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129134.pdf.

Guideline on good pharmacovigilance practices (GVP) Module IX-Signal management, http:// www.ema. europa.eu/ docs/ en_GB/document_library/Scientific_guideline/2012/06/WC500129138.pdf.

Guideline on good pharmacovigilance practices (GVP) Module VII-Periodic safety update report, http:// www.ema. europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/04/WC500142468.pdf.

Guidance for Industry-Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), http:// www.fda.gov/ downloads/regulatoryinformation/guidances/ucm126834.pdf.

U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Guidance for industry: Development and Use of Risk Minimization Action Plans, http:// www.fda.gov/ downloads/ RegulatoryInformation/Guidances/UCM126830.pdf.

Nicholson SC, Peterson J, Yektashenas B. Risk evaluation and mitigation strategies (REMS): educating the prescriber. Drug Saf. 2012 Feb 1; 35(2): 91-104.

Food and Drug Administration Compliance Program Guidance Manual. Chapter 53-Post marketing Surveillance and Epidemiology: Human Drug and Therapeutic Biological Products, http://www.fda.gov/downloads/Drugs/ Guidance ComplianceRegulatoryInformation/UCM332013.pdf.

Biswas P. Pharmacovigilance in Asia. J Pharmacol Pharmacother 2013;4(Suppl 1):S7-S19.

Paliwal YK, Mehan S, A., J. Pharmacovigilance:Tool for Global Drug Safety Analysis. Int Adv Pharm Res 2014;4.

Kumar S, Baldi A. Pharmacovigilance in India:Perspectives and Prospects. J of Drug Delivery and Therapeutics 2013;3(4):237.

Lis Y, Roberts MH, Kamble S, J Guo J, Raisch DW. Comparisons of Food and Drug Administration and European Medicines Agency risk management implementation for recent pharmaceutical approvals:report of the International Society for Pharmacoeconomics and outcomes research risk benefit management working group. Value in health. J of the Int Society for Pharmacoeconomics and Outcomes Res 2012;15(8):1108-18.

New EU Pharmacovigilance Legislation. Early Industry Experience, Challenges for Implementation and some Proposals, http://www.ema.europa.eu/ docs/en_GB/ document_library/Presentation/2012/12/WC500136110.pdf.

New pharmacovigilance legislation: focus on first year of operation, http://www.ema.europa.eu/docs/ en_GB/ document_library/Presentation/2014/02/WC500161015.pdf.

Gupta SK. Pharmacovigilance:current status & future challenges. Indian J of Medical Specialities 2013;41-4.

Planning for the Implementation of the New Legislation on Pharmacovigilance, http:// www.ema.europa.eu/ docs/en_GB/ document_library/Other/2011/04/WC500105349.pdf.




About this article

Title

A NEW ERA OF DRUG SAFETY – NEW EU PHARMACOVIGILANCE (PV) LEGISLATION AND COMPARISON OF PV IN EU, US AND INDIA

Keywords

Pharmacovigilance, European Medicine Agency, Good Pharmacovigilance practice, New EU PV Legislation, Food and Drug Administration, Signal detection, Risk Management Plan.

Date

26-07-2014

Additional Links

Manuscript Submission

Journal

International Journal of Pharmacy and Pharmaceutical Sciences
Vol 6, Issue 7, 2014 Page: 15-21

Online ISSN

0975-1491

Statistics

989 Views | 160 Downloads

Authors & Affiliations

Atul Khurana
Department of Global Vigilance, Fresenius Kabi Oncology Limited, Echelon Institutional Area, Plot No-11, Sector-32, Gurgaon-122001, Haryana, India,
India

Rajul Rastogi
Department of Global Vigilance, Fresenius Kabi Oncology Limited, Echelon Institutional Area, Plot No-11, Sector-32, Gurgaon-122001, Haryana, India,
India

Hans-joachim Gamperl
Department of Global Vigilance, Fresenius Kabi AG, Oberursel, Germany,
Germany


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