The air-dried roots of Scrophularin ningpoensis (Hemsi) are used against fever, swelling, constipation, pharyngitis, neuritis, and laryngitis in Chinese traditional medicine (1-3). There is only one report (4) on its chemical constituents: five compounds have been isolated, three of them are identified as harpagide, harpagoside, and angroside c, but the other two new compounds, an iridoid-related aglucone and an ester of 6
Background Pharmacovigilance (PV) plays an essential role in monitoring and raising awareness of adverse drug reactions (ADRs). Increasingly, ADRs are reported and PV information and activities are circulated via the Internet. PV actions are carried out by the Regulatory Agencies (RAs) responsible for medicinal products in each country.Objective The objective of this study is to ascertain and assess the operation and areas of competence of the PV system in Brazil and to compare them with those of Spain, the European Union (EU) and the United States (USA), through the information available on the websites of the RAs in each country. Methods A search of the information provided on the websites of these countries' RAs, establishing indicators to assess how far the information is available and accessible.Results The RAs we studied are similarly organised and they complied with most of the 38 indicators we defined to obtain and assess the information they provide on PV procedures and their systems for electronic reporting of ADRs. Brazil's RA, ANVISA, complied with 100% of the areas of competence analysed and with 92.11% of the indicators established for the study. Conclusions Brazil's PV system, through ANVISA, achieves a good level of performance, both in itself and compared to the other RAs. There is room for improvement in three of the indicators analysed.
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