In 1965, the European Community formulated the Medicines Directive (65/EEC) in order to unify the laws and regulations related to plant medicines among countries. In 1988, the European Community formulated the Guidelines for the Management of Herbal Products, which clearly stated: “Herbal medicine is a kind of medicine, and the active ingredients contained in it are only plants or preparations of herbal medicine. Herbal medicines must be licensed for sale. Standards of quality, safety and efficacy must be met before a product can be marketed.” The application for the license is required to provide the following information: 1. The qualitative and quantitative information of the components; 2. Description of manufacturing method; 3. Control of initial materials; 4. Quality control and identification to be carried out regularly; 5. Quality control and appraisal of finished products; 6. Identification of stability. In 1990, the European Community proposed GMP for the production of herbal medicines.
In December 2005, traditional medicine KlosterfrauMelisana was successfully registered in Germany. This product mainly consists of balsam grass, civil fragrance, angelica, ginger, clove, galangal, Eurogentian, treating mental tension and anxiety, headache, dysmenorrhea, loss of appetite, dyspepsia, cold and so on. In the UK, there are hundreds of applications for the registration of traditional medicines, but so far none for traditional Chinese medicine.
The basic concept of drugs in the United States is that the chemical composition should be clear, and in the case of compound preparations, the pharmacodynamics of each chemical component and the effects of their interactions on the efficacy and toxicity should be clear. Under the influence of the so-called orthodox concept of medicine, the US FDA has a very poor understanding of plant medicine, including traditional Chinese medicine, so it does not recognize natural plant medicine as medicine. However, under the pressure of huge medical care expenditure and strong public opinion, the US Congress passed the dietarysupplement Health Education Act (DSHEA) in 1994 through the unremitting efforts and lobbying of some small and medium-sized enterprises, which listed natural plant medicine including traditional Chinese medicine as a dietarysupplement. It can be said that dietary supplement is a special product between food and medicine. Although the specific indication cannot be indicated, its health care function can be indicated.
Natural herbal medicines produced and sold in the United States have legal status, that is, they are recognized for use in the prevention and treatment of disease. In 2000, in response to public demand, the President of the United States decided to establish the “****** Policy Council on Complementary and Alternative Medicine”, with 20 members appointed by the President directly to discuss the policy guidelines of complementary and alternative medicine and explore its potential value. In its official report to the President and Congress in 2002, ****** included “traditional Chinese medicine” in the system of complementary and alternative medicine.
In recent years, the FDA has strengthened the regulatory management of natural herbal medicines. In 2003, it started to implement GMP management for dietary supplements and set strict standards for the production and labeling of dietary supplements. The FDA published the Guidelines for the Development of Plant Drugs online and asked for comments worldwide. The Guiding Principles clearly point out that botanical medicines are different from chemical medicines, so their technical requirements should also be different from the latter, and expounds some characteristics of botanical medicines: the chemical composition of botanical medicines is usually a mixture of multiple components, rather than a single compound; Not all the chemicals in herbal medicines ****** are clear; In most cases, the active ingredients of herbal medicines are not determined ******; In some cases, the biological activity of plant medicine is not ****** definite and clear; Many methodologies for the preparation and processing of herbal medicines are largely empirical; Botanicals have extensive and long-term experience in human application. No obvious toxic side effects were found in the long-term and extensive application of herbal medicine in human body. Some herbal medicines have been marketed as health products or nutritional supplements.
Based on FDA’s understanding of plant drugs, the technical requirements for plant drugs in the Guiding Principles are different from those for chemical drugs, including: the technical requirements for preclinical research are relatively loose; The pharmacokinetic test can be handled flexibly. Special treatment for compound herbal preparations; Pharmaceutical technology requires flexible processing; The technical requirements of pharmacology and toxicology have been reduced. The guidelines represent a qualitative leap in the FDA’s approach to natural herbal medicines, including traditional Chinese medicines. The great change of the American government’s policy on herbal medicine has created the basic conditions for herbal medicine to enter the American market.
In addition to Veregen, which has already been approved, about 60 to 70 botanicals are in the pipeline so far.