Medical network on March 2 - on July 1, 2017 implementation of the traditional Chinese medicine of the People's Republic of China law article 30 of the highest degree of attention and discussion. Article 30 the provisions, the production meets the conditions prescribed by the state from ancient classic square compound preparations of Chinese medicine, when applying for drug approval number, can only provide non-clinical safety study materials. Shall be formulated by the pharmaceutical supervisory and administrative department under the state council together with the competent department of traditional Chinese medicine.
The so-called ancient classic square, is still widely used, curative effect, has obvious characteristic and advantages of classics written in ancient Chinese medicine prescriptions. And the specific catalogue shall be formulated jointly by the competent department of traditional Chinese medicine pharmaceutical supervisory and administrative department under the state council.
Debate 1 production approval number for too many ancient classic square?
Can be seen from table 1, the current domestic traditional Chinese medicine (TCM) number of approval before approval number 20 products are more than 200, visible Chinese medicine especially in traditional Chinese medicine for oral administration production approval of repeat problem is very serious. 20 products, there are three is single product, the remaining 17 is a compound, one of the most classic party and more approval is beginning in the song "pediatric medicine card straight strategics" liuwei dihuang pill.
Enterprises need to consider when classic party project now the formula and the formula of the product is approved, pay special attention to collect tongfang different data, such as composition of notoginseng and salvia miltiorrhiza products, currently listed products notoginseng effect, Dan seven pieces, etc. Expected the data to be Chinese traditional general name technical guiding principles formal execution can be expected only standardization.
Debate 2 goal is 6.1 the first class enterprise listed Chinese medicine registration?
According to the 2007 "drug registration management approach", derived from the ancient classic square compound preparation of traditional Chinese medicines registered classification, either "not in the new Chinese herbal 6 class sales in domestic market, natural medicine compound preparation of traditional Chinese medicines" in 6.1 class "traditional Chinese medicine compound preparations", or "generic" Chinese medicine 9 class.
Because 9 kind of generic drugs itself is free of clinical, thus avoid the incentive for 6.1 more impetus of new drug of TCM clinical. Given more than 9 class generics will face competition, manufacturing enterprises do more ancient classic square project is running a sole approval, namely for 6.1 class first listed the qualifications of Chinese traditional medicine.
According to salty data V3.2, 6.1 2016 class declaration for clinical medicine and production to a record low, it has correlation with 2015 clinical comprehensive verification, clinical inspection check list on July 22, 6.1 class registration filing, a total of 61 to accept order announcement withdrawal, 36, is making the but no approved production is expected to actively withdrawn accepts the number 15. Only one product golden flower clear sense of particles in drug clinical trial data are on-site verification plan announcement (no. 2). Can be avoided if the ancient classic square clinical, the comprehensive check if the products on the ancient classic withdrawal square directory, is expected to avoid clinical declare production directly? By the same token, anyone who approved clinical and in ancient classic square directory can be directly declare produced products?
Classical side 3 declare what need to prepare?
Although the ancient classic culled data from clinical trials of traditional Chinese medicine compound preparations declaration section, but 6.1 class still need to provide new drugs "review" "pharmaceutical information" and "pharmacology and toxicology data".
"Review" of the project 3 LiTi purpose and according to the part, should provide the prescription of TCM and the source and the selected topic basis, research status at home and abroad and the production, usage, and the variety innovation, feasibility, the rationality of the dosage form and the necessity of the clinical use of analysis, including the comparison with existing national standards of similar varieties, and will provide relevant and ancient literature reviews the theoretical basis of the traditional medicine and so on. Enterprise project before the need for adequate literature searching.
Pharmaceutical research data required to fully study of formula medicinal materials, including 8 medicinal material source and appraisal on the basis of ", "9. The ecological environment, growing characteristics, shape description, cultivation or plant (foster) technology, processing and processing methods of origin", "10. The draft standard herbs and draft specification, and to provide drug standard substance and relevant materials", "11. Provide plant, mineral specimens, plant specimens shall include flowers, fruits, seeds, etc". Overall, this will be conducive to comprehensive enterprise research of Chinese medicinal materials, such as the sig pharmaceutical; With GAP bases or master authentic medicinal material resources manufacturers can set off in search of the relevant prescription according to their own resources. Given that has the legal standard of Chinese herbal medicine, natural medicine may not provide 9 ~ 11, pharmacopoeia and ministerial standard herbs combination related formula also can be used as medicinal materials standard accumulated relatively weak enterprise project choice direction.
For companies, take and the cost of the main in - "pharmaceutical research data", "13. The test data in the study of chemical composition and literature" "14. Quality test data of the research work and literature" "15. Drug standard draft and draft specification, and to provide drug standard substance and relevant materials" "16. The sample inspection report" and "17. Research on drug stability test data and literature", and "pharmacology and toxicology research materials".
Since 2016, the CFDA verification of production technology is more and more strictly, set up production process, quality standard and drug curative effect will be the problem of such projects, the relationship between the quality standard of whether to establish fingerprint standard and suspense pending a disputed point.
Due to ancient classic square concrete directory still to be jointly by the department in charge of traditional Chinese medicine and pharmaceutical supervisory and administrative department under the state council, in the short term enterprise can do work is mainly literature retrieval, determine the undeclared and have clinical significance, large market potential, characteristics rigorous assessment conditions, such as classic, and according to the chosen classic research on previous copy.
Debate over 4 children party opportunity?
Clinical difficult children, classic party from clinical will motivate proprietary Chinese medicine enterprises to actively layout children medicine market. Children's medicine exclusive sense is limited, however, the above-mentioned "pediatric medicine card straight tactic" is a relatively classic pediatric monographs, including volume, a total of 117 party attached party 15 party; Yan Shi theory and 40 pediatric.
Traditional Chinese medicine often appear dross and the essence of coexisting phenomenon, the enterprise needs to preliminary ruled out some parties, such as stop sweat - "use so the cattail leaf fan ashes, if no fan, will therefore only pu burning ash porphyrization, take just a little money, each tune he drank, always" this kind of hard to industrialization. In addition, contains small poisonous drugs also to choose.
Treatment of disease by ancient Chinese pediatric monographs or boils with fever, rash, gastrointestinal discomfort, and upper respiratory tract disease is given priority to, these products are now listed many exclusive products. At present our country pediatric medicine more deficiency in western medicine to treat disease system of medicine, classic party want in pediatric market, must to modern medical system to do further research.
Summary > > >
The opportunity of ancient classic square as a traditional Chinese medicine industry, research and development of a project is expected to cost between 2 million ~ 3 million yuan. Before directory and related conditions has not yet been determined, traditional Chinese medicine production enterprises short-term should be prepared reagent, disease, and market research, the early stage of the first lock several target products.
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