Comparative evaluation of pharmacovigilance regulation of the United States, United Kingdom, Canada, India and the need for global harmonized practices
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 k...
| Main Authors: | , |
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| Format: | Article |
| Language: | English |
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Wolters Kluwer Medknow Publications
2018-01-01
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| Series: | Perspectives in Clinical Research |
| Subjects: | |
| Online Access: | http://www.picronline.org/article.asp?issn=2229-3485;year=2018;volume=9;issue=4;spage=170;epage=174;aulast=Hans |
| _version_ | 1818521729620770816 |
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| author | Mohit Hans Suresh Kumar Gupta |
| author_facet | Mohit Hans Suresh Kumar Gupta |
| author_sort | Mohit Hans |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-11T01:55:17Z |
| format | Article |
| id | doaj.art-fce74e72c703456caf7e103d24ceb7a5 |
| institution | Directory Open Access Journal |
| issn | 2229-3485 |
| language | English |
| last_indexed | 2024-12-11T01:55:17Z |
| publishDate | 2018-01-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | Perspectives in Clinical Research |
| spelling | doaj.art-fce74e72c703456caf7e103d24ceb7a52022-12-22T01:24:39ZengWolters Kluwer Medknow PublicationsPerspectives in Clinical Research2229-34852018-01-019417017410.4103/picr.PICR_89_17Comparative evaluation of pharmacovigilance regulation of the United States, United Kingdom, Canada, India and the need for global harmonized practicesMohit HansSuresh Kumar GuptaThe 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.http://www.picronline.org/article.asp?issn=2229-3485;year=2018;volume=9;issue=4;spage=170;epage=174;aulast=HansAdverse drug reactiondrug safetyharmonizationpharmacovigilance |
| spellingShingle | Mohit Hans Suresh Kumar Gupta Comparative evaluation of pharmacovigilance regulation of the United States, United Kingdom, Canada, India and the need for global harmonized practices Perspectives in Clinical Research Adverse drug reaction drug safety harmonization pharmacovigilance |
| title | Comparative evaluation of pharmacovigilance regulation of the United States, United Kingdom, Canada, India and the need for global harmonized practices |
| title_full | Comparative evaluation of pharmacovigilance regulation of the United States, United Kingdom, Canada, India and the need for global harmonized practices |
| title_fullStr | Comparative evaluation of pharmacovigilance regulation of the United States, United Kingdom, Canada, India and the need for global harmonized practices |
| title_full_unstemmed | Comparative evaluation of pharmacovigilance regulation of the United States, United Kingdom, Canada, India and the need for global harmonized practices |
| title_short | Comparative evaluation of pharmacovigilance regulation of the United States, United Kingdom, Canada, India and the need for global harmonized practices |
| title_sort | comparative evaluation of pharmacovigilance regulation of the united states united kingdom canada india and the need for global harmonized practices |
| topic | Adverse drug reaction drug safety harmonization pharmacovigilance |
| url | http://www.picronline.org/article.asp?issn=2229-3485;year=2018;volume=9;issue=4;spage=170;epage=174;aulast=Hans |
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