Efficacy, safety, quality control, marketing and regulatory guidelines forherbal medicines (phytotherapeutic agents)

This review highlights the current advances in knowledge about the safety, efficacy, quality control, marketing and regulatory aspects of botanical me dicines. Phytotherapeutic agents are standardized herbal preparations consi sting of complex mixtures of one or more plants which contain as active ing redients plant parts or plant material in the crude or processed state. A m arked growth in the worldwide phytotherapeutic market has occurred over the last 15 years. For the European and USA markets alone, this will reach abo ut $7 billion and $5 billion per annum, respectively, in 1999, and has thus attracted the interest of most large pharmaceutical companies. Insufficien t data exist for most plants to guarantee their quality, efficacy and safet y. The idea that herbal drugs are safe and free from side effects is false. Plants contain hundreds of constituents and some of them are very toxic, s uch as the most cytotoxic anti-cancer plant-derived drugs, digitalis and th e pyrrolizidine alkaloids, etc. However, the adverse effects of phytotherap eutic agents are less frequent compared with synthetic drugs, but well-cont rolled clinical trials have now confirmed that such effects really exist. S everal regulatory models for herbal medicines are currently available inclu ding prescription drugs, over-the-counter substances, traditional medicines and dietary supplements. Harmonization and improvement in the processes of regulation is needed, and the general tendency is to perpetuate the German Commission E experience, which combines scientific studies and traditional knowledge (monographs). Finally, the trend in the domestication, productio n and biotechnological studies and genetic improvement of medicinal plants, instead of the use of plants harvested in the wild, will offer great advan tages, since it will be possible to obtain uniform and high quality raw mat erials which are fundamental to the efficacy and safety of herbal drugs.