| アブストラクト | The primary focus of the pharmacovigilance (PV) practice has been on the collection, assessment, and reporting of the adverse drug reactions to medicinal products. Globalization of the pharmaceutical industry has prompted efforts to toward harmonization of PV practices worldwide to enable improved knowledge of medicine's benefit-risk profile and risk communication. Even as PV has evolved over the past decade, there still exist few areas of discordance across global PV practices. This article compares the PV legislation in the United States, United Kingdom, Canada, and India with a view to understand areas of harmony in the current legislation across regions and further compare health authorities' requirements with recommendations made by international organizations. Identification of potential areas of disharmony would pave the way to design solutions and strategies toward creation of a comprehensive PV system, which can be easily implemented across the globe, thus promoting the safer use of medicines. |
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| ジャーナル名 | Perspectives in clinical research |
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| 投稿日 | 2018/10/16 |
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| 投稿者 | Hans, Mohit; Gupta, Suresh Kumar |
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| 組織名 | Department of Clinical Research, Delhi Institute of Pharmaceutical Sciences and;Research, New Delhi, India.;Department of Clinical Research, Delhi Pharmaceutical Sciences and Research;University, New Delhi, India. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/30319947/ |
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