Traditional Chinese medicine formula particles or will be completely opened!

Source: Cypress blue 2015-11-23 recently, cypress blue learned from the sources that "the management measures for traditional Chinese medicine formula granules (Draft)" (hereinafter referred to as the draft for comments) are intensively soliciting opinions in the industry, or will be published soon In recent years, the traditional Chinese medicine prescription granule is a product of the reform of traditional Chinese medicine pieces Because more and more people do not like the decoction of the original pieces, the production of Chinese herbal pieces is decreasing at the rate of 14% - 28% Traditional Chinese medicine formula granule is a kind of granule for clinical formula of traditional Chinese medicine, which is made of single Chinese medicine pieces by extraction and concentration It is a new dosage form which is easy to carry and take, and has significantly improved effect on traditional Chinese medicine and traditional Chinese medicine pieces Because it is convenient to take, it is popular because it is in line with modern people's habits According to industry estimates, the market size in 2013 is about 5 billion, with an annual growth rate of 40-50% According to this estimation, the annual sales volume of TCM formula granules will reach 10 billion yuan Although the market of traditional Chinese medicine formula granules is objective, only 6 enterprises have the qualification because they were mainly in the scope of pilot before   According to the consultation notes, in the future, the regulatory authorities will release the formulation particles, and the traditional Chinese medicine production enterprises will produce the formulation particles, which will be approved by the provincial food and drug administration where the enterprise is located, and the production scope of the enterprise's drug production license will be increased with the formulation particles, and then according to the requirements of the detailed rules for the record management and implementation of the formulation particles of traditional Chinese medicine, the regulatory authorities will release the formulation particles, and the traditional Chinese medicine production enterprises will produce the formulation particles, which will be approved by After submitting the filing data of traditional Chinese medicine formula granules to the local and provincial food and drug supervision and administration departments, they can be produced The filing conditions include: the production scope of granules has been obtained, the complete production capacity of processing, extraction, concentration, drying and granulation of Chinese herbal pieces has been obtained, which meets the GMP requirements; the quality supervision personnel have been available, the drugs have been tested at the same time, and they promise to bear the risk responsibility The quality requirements are more stringent Although the traditional Chinese medicine formula granules are under the record system management, this does not mean that the regulatory authorities have relaxed the requirements, which is mainly reflected in: 1 Strict requirements for traditional Chinese medicine Traditional Chinese medicine formula granule production enterprise shall entrust a qualified third party to evaluate the resources of the used traditional Chinese medicine and fully trace the source, fix the origin of the traditional Chinese medicine, and implement the specific production location, planting / breeding enterprise or farmers, collectors, purchasers, primary processors, warehousing and logistics enterprises, etc Species, including subspecies, varieties or varieties, of medicinal animals and plants cultivated, cultivated or collected in the wild shall be identified accurately Different kinds of Chinese medicinal materials shall not be mixed with each other For those that can be planted / cultured artificially, it is recommended that the Chinese herbal medicines come from the standardized planting / breeding base established by the Chinese herbal medicine formula granule production enterprises themselves or jointly in accordance with the requirements of the Chinese herbal medicine production quality management specification The traditional Chinese medicine formula granules are fed with pieces of traditional Chinese medicine, and the production enterprises should have the processing ability of pieces of traditional Chinese medicine 2 The flight inspection and blacklist system of the State Administration has incorporated the traditional Chinese medicine formula particles into the drug electronic supervision system, and implemented the whole process tracking and supervision on the production and use of traditional Chinese medicine formula particles The State Food and drug administration shall, in combination with GMP flight inspection and supervisory sampling inspection, organize the supervision and management of the filed traditional Chinese medicine formula particles, and improve the daily supervision and inspection system focusing on random sampling Establish the blacklist system of traditional Chinese medicine granule production enterprises 3 The provincial food and drug administration shall be responsible for the daily inspection no less than twice a year The provincial food and drug administration shall be responsible for the filing of traditional Chinese medicine formula particles in its own administrative region, and shall be responsible for the daily supervision and inspection of the production enterprises of traditional Chinese Medicine formula particles in its own administrative region according to the detailed production process of the filing The regular inspection organized every year shall not be less than twice 4 Encourage the National Pharmacopoeia Committee of high standards to organize the formulation and revision of unified drug standards for traditional Chinese medicine formula granules (hereinafter referred to as "unified standards") The research institutions and manufacturers that carry out the scientific research on the standards of traditional Chinese medicine formula granules can provide research data and drug standards to the national pharmacopoeia committee independently or jointly as required For the same variety produced by multiple enterprises, the formulation and revision of drug standards should be unified on the basis of science and rationality, and sticking to the principle of "high not low" A batch of mature ones will be released In the spirit of encouraging enterprises to participate in the drafting of the standard and defining the responsible body, the name of the drafting unit shall be indicated in the approved standard of traditional Chinese medicine formula granules 5 The draft also mentioned that the training and assessment of the rational use of traditional Chinese medicine formula granules by medical staff should be strengthened, the prescription review and doctor interview system should be established, the prescription behavior of doctors should be standardized, and the unreasonable use of traditional Chinese medicine formula granules should be avoided Chinese medicine enterprises are good, and the end of decoction pieces enterprises? According to rollin, a senior Chinese medicine expert, TCM formula granules are used as TCM hospitals Although the use of prescriptions by clinicians is different from the theory of traditional Chinese medicine, and lack of substantial scientific experimental basis, the government has been under supervision for a long time in the face of current large-scale illegal behaviors such as unqualified quality of clinical pieces, adulteration, dyeing and weight gain, the characteristics of agricultural and sideline products of traditional Chinese medicine, wide region, low access threshold, large number of varieties, and different drug use in different regions It's an embarrassing dilemma of difficult control and supervision The introduction of traditional Chinese medicine formula granules is the only way for the government to solve the problems of basic source, process source and relatively stable quality of traditional Chinese medicine Formula granules belong to products with relative quality control If they are popularized on a large scale, many pieces of Chinese medicine enterprises are bound to go to the end The enterprises of Chinese medicine pieces of Chinese medicine must change to the production enterprises of high-quality pieces of Chinese medicine or special pieces of Chinese medicine It will be a very good news for traditional Chinese medicine manufacturers (with the production range of granules and the conditions for washing, drying, processing and complete preparation process of granules) What's more, under the pressure of overall drug price reduction, if Chinese herbal formula granules are managed as pieces of decoction, and pieces of decoction are not affected by the proportion of drugs, bidding price reduction, etc., the market may further break out It is a very good news for the Chinese medicine enterprises that have done the production and processing of decoction pieces, gap planting base and complete pre-treatment and extraction of Chinese medicine in the early stage.