We are pleased to announce that the last issue of Przemysł Farmaceutyczny 6/2019 / Produkcja Kontraktowa (Pharmaceutical Industry 6/2019 / Contract Production), a bimonthly magazine addressing pharmaceutical industry topics, features our article by Marlena Dudek-Makuch, PhD (Pharm.), and Natalia Palacz (Regulatory Department; Research and Development Division, Curtis Health Caps). The piece is the first of two articles on plant-based raw materials used in dietary supplements.
The article summarises the current state of knowledge on plant-based food supplements, contemporary trends, and guidelines relating to plant-derived ingredients of food supplement products.
The publication of these articles puts into focus the expertise of Curtis Health Caps in the area of plant-based raw materials which has been systematically expanded over the recent years. Last year, our team was joined by an expert with a PhD degree and 20 years’ experience in phytochemical and biological research, and scientific publications on herbal raw materials. Based on our expertise in this field, we are able to evaluate the safety of plant-based raw materials used in the formulation of various regulatory categories of products (dietary supplements, medical devices and herbal medicinal products).
The safety assessment of plant-based raw materials is conducted in accordance with EFSA guidelines (“EFSA guidance document for the safety assessment of botanicals and botanical preparations intended for use as food supplements”, “EFSA Compendium of Botanicals”) and guidelines issued by the European Medicines Agency’s (EMA) Committee on Herbal Medicinal Products (HMPC)).
We are able to perform the safety assessment of products containing plant-based raw materials on the basis of review of scientific information (clinical and non-clinical literature data; EMA, WHO and ESCOP monographs).
In view of the current activities of the Team for Dietary Supplements at the Chief Sanitary Inspectorate related to specifying the maximum amounts of herbal raw materials in food supplements, the safety of plant-based raw materials used in the formulation of dietary supplements seems to be a particularly important issue – especially in the aspect of validation of product safety before market launch.
Curtis Health Caps also has a team of experienced R&D analysts who develop and validate analytical methods for determining the plant-based raw material in the product, and evaluate the stability of raw materials and products containing herbal materials. Our human resources are thus one of our most valuable assets ensuring comprehensive services in the field.
We hope you enjoy the article, and we also encourage you to have a look at the second part which will be published in the next issue of Przemysł Farmaceutyczny (1/2020).
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