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Postmarket regulatory activity covers the following steps:
Postmarket review of products
Monitoring and surveillance in the marketplace
Problem reports and recalls
Laboratory testing
Adverse reaction reporting
The risk assessment framework for complementary medicines covers
the following steps (F. Cumming, in Noller et al., 2001):
Characterization of substance
History and patterns of previous human use
What, if any, adverse reactions have arisen from use
Biological activity
Toxicology
Clinical trials
Conclusions and recommendations.
2. Emerging European Regulation on the Safety of
Herbal Medicines
The European Community definition of a medicinal product is:
‘‘Any substance or combination of substances presented for treating or
preventing disease in human beings or animals’’;
‘‘Any substance or combination of substances which may be administered
to human beings or animals with a view to making a medical
diagnosis or restoring, correcting or modifying physiological function
in human beings or in animals is likewise considered a medicinal
product’’; and
Any ‘‘medicinal product’’ requires a product license.
Directive 65/65 requires showing through toxicology and pharmacology
tests the potential toxicity of the product and any dangerous or undesirable
toxic effects under proposed conditions of use. Specifically, Directive 65/65
requires:
Single-dose toxicity
Repeat-dose toxicity
Reproductive toxicity
Teratogenicity/embryo/fetal toxicity
Mutagenicity
Carcinogenicity
Pharmacokinetics
Pharmacodynamics
Bodeker