Data function requirements, medicinal

With respect to development pharmaceutics data, the requirements stated in Directive 75/318/EEC (as amended) are included in the Annex to that document at Part 2 A 4 (page 20 of the Rules Governing Medicinal Products in the European Union, Volume 1, Pharmaceutical Legislation Medicinal Products for Human Use). With respect to the general requirement for pharmaceutical products this states 4.1 An explanation should be provided with regard to the choice of composition, constituents and container and the intended function of the excipients in the finished product. This explanation shall be supported by scientific data on development pharmaceutics. The overage, with justification thereof, should be stated. This, then, is the legal requirement. Needless to say, there is a... 

In the food industry, these natural products have now been classified under a new class of food called nutraceuticals or functional foods, because these products provide a health benefit beyond basic nutrition 22, 23). According to Wilkinson 24), most of the nutraceuticals used in the food industry are plant derived. Further, Addae-Mensah (25), showed that the world trade in medicinal plants accounts for about 30% of the total dmg market and was estimated excluding plants used as raw material sources for the essential oils required to manufacture cosmetics, food additives and other non-medicinal purposes. The increased recogiution of the value of natural products in the pharmaceutical, neutraceutical, cosmetic and other industries have created a huge demand for raw natural products. By taking Rooibos tea as an example from South Africa, Wilson 26) in detail describes the demand for Rooibos from different countries. However, for many natural products estimation of the actual demand is very difficult and the data sparse given the diversity of natural products used across industries and production variation within and across countries and the lack of... 

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