保健品和中藥新藥的申報審批的比較(文件)
【正文】 tary Medicinal Products (scientific evaluation board) working parties: pharmacovigilance, efficacy, safety, quality, biotechnology, herbal, ad hoc working parties European Commission Which Medicinal Products are covered by Pharmacovigilance Activities? any medicinal products authorised in the EU ? centrally authorised ? authorised through mutual recognition procedure ? purely nationally authorised ? new / old medicinal products ? biologicals: vaccines, blood products, others ? herbal medicinal products ? alternative and plementary medicinal products Events of ADR ? Hepatotoxicity of KavaKava ? 41 cases reported to BfArM ? exposure one week to two years, ? different extracts, dosages, comedication ? Hepatitis, Enzymes ?, ? Icterus, Liver necrosis ? Liver transplant (6 cases) ? Death (3 cases) Interactions of herbal medicinal products with other medication ? Hypericum extract Phenprocoumon ? Digoxin ? Ciclosporine ? Indinavir ? Theophylline ? OC ? Antiepileptics ? Irinotecan ? Interactions of herbal medicinal products with other medication ? Garlic ? Aspirine / risk of bleeding ? ? Saquinavir AUC ? ? Ginkgo extract ? Aspirine / risk of bleeding ? ? Isphagula husk ? Lithium / absorption ? ? KavaKava extract ? Alprazolame / ADR ? Pharmacovigilance Actions in Germany ? Year Products Substance/Reason ? 1981 336 Aristolochic acid / carcinogen ? 1987 59 Vinca minor / immunotoxicity ? 1988 1 Echinacea (parenteral) / anaphylaxis ? 1990 2,817 Pyrrolizidinic alkaloids / carcinogen ? 1991 / 1993 14 Ginkgo biloba (parenteral) / anaphylaxis ? 1991 95 Rauvolfia / aflatoxins ? 1992 1,427 Anthranoids / chronic toxicity ? 1992 159 Rubia tinctorum / genotoxicity Pharmacovigilance Actions in Germany ? Year Products Substance/Reason ? 1992 7 Teucrium chamaedris / hepatotoxic ? 1994 44 Sassafras albidum / genotoxic carcinogen ? 1997 84 Cumarin (. Melilotus) / hepatotoxic ? 1997 105 Ginkgo / Ginkgolic acid / allergic reactions ? 1999 180 Chelidonium / hepatotoxic reactions ? 1999
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