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Botanical Drug Products
Historically plants and other natural products have been the major source of many important drugs.
During the 20th Century the advent of synthetic chemistry and the discovery and use of New Chemical Entities (NCEs) in drug development dominated the pharmaceutical industry and resulted in fewer and fewer drugs being developed from plant sources in the West. The increasing importance of countries such as India and China, where the healthcare systems have for centuries and continue today to rely on their traditional plant-based medicines has helped to foster a growing interest in the West in traditional medicines and their relevance in treating many of the diseases that afflict the world today. In the 21st Century scientists and companies like Phynova are using some of these traditional medicines and their modern counterparts as a 'discovery engine' for developing new licensed pharmaceutical drugs, which are now commonly referred to as Botanical Drug Products.
In recent years the FDA and the EMEA have reviewed the regulatory frameworks governing the development and use of botanical drugs.
In June 2004, the FDA issued the final version of the Guidance for Industry Botanical Drug Products ("the Guidance") which sets out the framework for a new category of licensed drugs. Under these guidelines, botanical drugs can be developed more quickly and more cheaply than conventional synthetic NCE pharmaceuticals. The Guidance states, "because of the unique nature of botanicals, the FDA finds it appropriate to apply regulatory policies that differ from those applied to synthetic, semi-synthetic, or otherwise highly purified or chemically modified drugs (including antibiotics)".
The Guidance sets out detailed guidelines for the development of this new class of licensed drugs. With the publication of this document, the FDA has effectively launched in the West an entirely new pharmaceutical category. In the EU, the approach to registering botanical drugs has varied from country to country. To achieve consistency in 1995 the EMEA appointed an ad hoc Working Group on Plant Medicinal Products. The mandate of this group is to promote harmonisation of the assessment of botanical medicinal products, to examine the existing legislation, and to recommend how plant medicinal products can effectively be accommodated by it. This has led to the introduction of a number of guidance documents for the registration of 'new' botanical drugs. The establishment of working parties for botanical drugs demonstrates a new and more positive climate for the registration of these products in Europe.