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The great untapped potential of herbal medicines

13 lipca 2020, 09:01
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The great untapped potential of herbal medicines

For the pharmaceutical industry it only makes sense to spend time and money on developing a new drug if the application of the drug, the compound from which it is made or the process used to make it can be patent protected. Since drug development is fairly costly, the pharmaceutical industry is only interested in developing completely new active drug ingredients, as only these are patentable.To get more news about radix astragali, you can visit shine news official website.

The pharmaceutical industry is not generally that interested in medicinal plants as they do not contain a single definable and completely new active ingredient. Phytopharmaceutical producers are also well aware of the patent protection problem and solve it by developing special extracts with production processes that they can protect with a patent. They “invent” a special method to enrich or remove substances from an extract, so that the extract becomes something special. This invention can then be protected with a patent. These extracts are tested in clinical trials, approval is sought and, all being well, granted, as happens with standard drugs. Although this special manufacturing process enables manufacturers to protect their plant-based product, other manufacturers can easily find a way around it.
How do the regulatory requirements for herbal medicines, i.e. extracts, differ from those for synthetic drugs?

EU legislation accommodates the producers of herbal medicines to a large extent. For example, if a WHO or other monograph demonstrates that the plant for which regulatory approval is sought is a well-known medicinal plant, and expert monographs confirm the plant’s efficacy, only one to two small clinical trials are needed for the particular medicine to obtain a “well established use” marketing authorisation. The applicant needs to demonstrate the quality of the product, but does not need to carry out the comprehensive clinical trials that are mandatory for chemical drugs.

The extensive WHO, ESCOP* and HMPC** monograph collections list significantly more medicinal plants than there are preparations with the “well established use” authorisation on the market. The EU has introduced a European directive for a simplified registration of traditional herbal medicinal products. Manufacturers seeking approval for so-called THMP (traditional herbal medicine products) have to demonstrate that these products have been used for medical application for a period of least 30 years, including at least 15 years in the EU. The applicant also needs to demonstrate the efficacy of the herbal medicine for which approval is sought, and that it does not have any adverse effects. The majority of herbal medicine producers therefore use THMPs. However, the drawback of this option is that the product cannot be protected with a patent. The first company that places a THMP-based product on the market does all the registration work, and all those that come after can simply reproduce the product.


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