[Requirements for quality of approved plant medicines].
Herbal medicinal products differ substantially from drugs with synthetic active ingredients. Whereas the active ingredients of synthetic drugs are chemically well defined and pure substances, those of phytopharmaceuticals are plants, parts of plants or extracts. Therefore starting material of high quality and a standardised manufacturing procedure are particularly important for phytopharmaceuticals. Thus the documentation of the quality of a herbal medicinal product is crucial. The quality criteria aim to guarantee a phytopharmaceutical of high and constant quality and as well as a successful and reproducible therapy. The new Swiss Federal Law on Medicinal Products and Medical Devices (Law on Therapeutic Products--LTP) came into effect on 1 January 2002. The Intercantonal Office for the Control of Medicines IOCM which previously was in charge of herbal medicinal products was closed down and together with the Therapeutic Products Section of the Swiss Federal Office of Public Health SFOPH merged to create Swissmedic, the Swiss Agency for Therapeutic Products. Swissmedic is now responsible for affairs related to herbal medicinal products. The following article gives an overview of the current quality requirements of phytopharmaceuticals. These are now based on the LTP, but the essence remains largely unchanged.
Schweizerisches Heilmittelinstitut, Bern.
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Allemann
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Herren
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Badertscher
D017277:Drug Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D008517:Phytotherapy; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence*; D013557:Switzerland
D010936:Plant Extracts