Herbal medicinal products Clinical trials

Medicines Act for relevant medicinal products, including section 7 (and consequently all exemptions relating to section 7). Relevant medicinal products are defined in the 1994 Regulations as those medicinal products for human use to the provisions of Directive 2001/83/EC apply. This broad definition includes most medicinal products. The exceptions are medicinal products for clinical trial use, products prepared in a pharmacy in accordance with a pharmacopoeial formula for direct supply to a patient, intermediate products, registered homoeopathic products, non-industrially produced herbal remedies and some products which are not medicinal products within the meaning of the Directive, but which by order have been made subject to control under the Medicines Act 1968. For products designated under such an order, the old provisions on particular patient supply are still applicable. In practice, there are very few such products. 

Because of the interest in and popularity of alternative and complementary medicines and healing practices, the scientific method is being applied to a wide variety of these remedies. Different types of studies seek to establish if and how individual, alternative medicines exert their effect. Clinical trials are being conducted to compare a specific alternative medicines with the accepted conventional medical standard of care for a specific condition thus, for example, an herbal extract may be compared with a pharmaceutical-grade drug to demonstrate unequivocally the safety and effectiveness of a product or practice. However, complementary and alternative medicine has only recently been deemed worthy of scientific scrutiny (for decades many natural remedies and practices were dismissed outright as being obviously inferior to Western science-based medicine), and many alternative therapies have not yet been... 

GMPs have spread from being applicable strictly to drug dosage form manufacture, to a world where every dosage form or business sector involved with medicinals or their constituents has a detailed GMP code. These sectors include herbal medicines, active pharmaceutical excipients (inactives), clinical trial manufacture, biotechnology-sourced materials, sunscreen products, and so on. 

Numerous human clinical studies have been reported on mistletoe or its preparations as a treatment for cancer. In most of the studies, the survival and tumor recurrence were the end points. Mar r of these studies attributed beneficial effects to mistletoe products in terms of improvements in survival, improvements in quality of life, and/or stimulation of the immune system. " However, most of the studies have serious flaws in study design, and they have often yielded inconsistent outcomes. The variation in the type of mistletoe products used from one study to the other makes the analogy difficult. Although mistletoe is one of the most widely studied herbal medicines for cancer, well-designed clinical trials are still needed to decipher its absolute potential in cancer treatment. 

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