Classic prescriptions of traditional Chinese medicine: more convenient registration and more rigorous research

[market analysis of chinapharma.com] on October 8, just one day after the golden week of "national day and Mid Autumn Festival", the general office of the CPC Central Committee and the general office of the State Council jointly issued the opinions on deepening the reform of the review and approval system and encouraging the innovation of pharmaceutical and medical devices (hereinafter referred to as the opinions) The opinions put forward 36 reform measures in six parts from the perspectives of reforming clinical trial management, accelerating market review and approval, promoting innovation of medical devices and development of generic drugs, strengthening life cycle management of medical devices, enhancing technical support capacity and strengthening organization and implementation These contents have been well known in the industry and clearly become the reform direction of drug regulatory policy since the issuance of No.44 document of the State Council (opinions of the State Council on the reform of drug and medical device review and approval system) in 2015 However, the joint release of "two offices" with ultra-high specifications has aroused thousands of waves and caused many problems The collective sensation of the medical circle, the cheers of "the spring of China's medical industry has come" are endless Seeking common ground while reserving differences, after the brief excitement of classic name Fang Deli, the focus of the industry turned to the issue of relevant supporting documents, operation methods and procedures after the release of the opinions As a result, just a day later, on October 9, the supporting documents of the opinions appeared rapidly To many people's surprise, this document is not a hot topic before, but the regulations on the simplified registration and approval of traditional Chinese medicine famous formula and compound preparation (Draft for comments), the application data requirements for the standard decoction of traditional Chinese medicine famous formula and compound preparation of traditional Chinese medicine classic formula (draft for comments) (hereinafter referred to as draft for comments), which originates from the opinions 》Article 13 in the paragraph "support the inheritance and innovation of traditional Chinese medicine", there are only a few vague expressions Looking back on the new drug approval of CFDA in 2016, only 2 new drug approvals were recorded for traditional Chinese medicine / natural medicine, and the situation is not optimistic In 2015, there were 7 new drug approvals for traditional Chinese medicine / natural medicine In the earlier years before the reform of drug review and approval system, although the number of new drug approvals of traditional Chinese medicine was slightly larger, the total number of new drug approvals accounted for less than 10% There are many reasons for this situation, one of which is the lack of scientific evaluation methods that can be agreed by all parties, which leads to great uncertainty in the application of traditional Chinese medicine The release of the draft highlights the wisdom of the leading departments: the controversial issues should be put first, the innovation of traditional Chinese medicine should start from the inheritance, and the application of new traditional Chinese medicine should start from the part without (or less) dispute In order to achieve this goal, the ancient classic prescription, which has been tested by long-term medical practice and has been proved by a large number of patients' medication effect, has been put on the front stage, as the source of traditional Chinese medicine compound preparation, enjoying the treatment of simplifying the registration and approval procedures According to the data, there are nearly 100000 prescriptions recorded in Chinese history, and the number of classical prescriptions is huge, but only a small part of them have been developed at present The large varieties of traditional Chinese medicine, such as Yunnan Baiyao, Niuhuang Qingxin pill and Lianhua Qingwen capsule (improved), have been widely recognized by medical institutions and consumers, and have achieved great success in industrialization With the final improvement and landing of the draft for comments, as well as the emergence of the first batch of the legendary list of 100 classic prescriptions, we believe that there will be more wonderful medical heritage for the benefit of mankind The registration is more convenient and the research is more rigorous While promoting the classical famous prescriptions to enjoy the convenience of registration and approval, in order to reverse the shortcomings that have been criticized in the history, such as the confusion of traditional Chinese medicine standards, the lack of stable and uniform production, and the lack of safety evaluation, the regulatory authorities put forward very strict requirements for the application materials of the modified compound preparations First of all, it is reflected in the recognition of classic famous party qualification The catalogue must be issued by the national regulatory authorities The preparation method, dosage form, administration route, daily quantity of decoction pieces, and the function and indications expressed in TCM terms must be consistent with those recorded in ancient medical books, and there should be no modern toxicological evidence of toxic drugs, and the scope of application should not include emergencies, critical diseases, infectious diseases, pregnant women, infants and other special uses Drug crowd The research materials should reflect the history of prescriptions, the evolution of prescriptions, discuss the etiology, pathogenesis, treatment principles and treatment methods of classic famous prescriptions, and analyze the Compatibility Principles of prescriptions (such as monarch, minister, assistant, envoy) and the relationship between drug composition Secondly, it is also reflected in the new concept of "standard Decoction" Please don't be misled by the words, "standard Decoction" is not medicine juice, but refers to the traditional Chinese medicine medicinal substance prepared on the basis of the preparation method of ancient classic prescriptions recorded in ancient medical books, which may take the form of extract, dried medicine soup, or even uncooked powder It is the reference material for quality control, and the guarantee is consistent with traditional Chinese medicine clinical medication "Standard Decoction" will have national standards Although enterprises will participate in this standard, once the standard is determined, it will serve as the common material basis for all the declared classical prescription compound preparations It can be used as a metaphor to realize the unified "standard Decoction" which is equivalent to the API with clear ingredients used in chemical preparations This will completely reverse the embarrassing situation of different quality of finished products caused by different feeding standards of each Chinese patent medicine factory in the past In order to achieve the standard unification of "standard Decoction", not only one classic prescription corresponds to one "standard Decoction" (except for the classic prescription containing multi-base original medicinal materials), but also the declaration unit applies for the basic raw materials, medicinal parts, place of origin, collection period, initial processing method of place of origin, preparation and processing of decoction pieces, and differences between batches A series of problems such as ecological environment, morphological description, growth characteristics, planting or breeding (artificial production) technology of medicinal materials are even involved in the research   This is not over In the process of compound preparation, relevant research work should continue The applicant should establish quality control measures from the source of medicinal materials to the whole chain of decoction pieces, intermediates and preparations, and the whole process should be compared with the "standard Decoction" to ensure the consistency of the preparation process and the "standard Decoction" (if there is any change, the time, content and rationality of the change should be explained Sex) After that, although the classic prescription is exempt from clinical trials, it still needs to do non clinical safety studies, including drug toxicity test, genetic toxicity test, reproductive toxicity test, carcinogenicity test, etc., which will be disclosed in the drug specification After listing, the production enterprise shall carry out ADR monitoring in accordance with the measures for the administration of ADR reporting and monitoring, and shall make an annual summary report to the drug regulatory department These work contents are more rigorous than the previous work, especially a large number of "adverse reactions are not clear" expressions in the manual of Chinese patent medicine will disappear, which is expected to give doctors and patients the right to know about the medicine, and avoid the big blunder of bad merchants The business opportunity is very big, and the voice of simplifying the registration and approval of classical prescription compound preparation has been in the industry for a long time At present, based on the fact that the innovation of chemical medicine and biological medicine is still in its infancy, and it will take a long time to achieve results, and there is a huge dilemma of capital investment The development of classic prescription compound preparation with relatively less investment and policy support has become the way for many pharmaceutical enterprises to seek Well informed people have been in the private circle of experts, pickpockets, research The appearance of the draft now means that the time for the policy to be officially introduced will not be far away As a new thing, it has a great advantage in the market In particular, the concept of "standard Decoction" and the goal of quality control in the whole process of medicinal materials - decoction pieces - standard decoction - preparation have created an advantageous position for the pioneers to formulate quality standards and have the opportunity to exclude competitors with technical threshold And in the establishment of the original medicine, fixed origin and other aspects of pioneers also have the convenience of seizing resources But it's not that simple In addition to the possibility of everyone going to the blue sea and turning into the Red Sea, there are still some problems in the use of the classic prescription compound preparation that deserve careful consideration by the enterprise For example, "functional indications should be expressed in terms of traditional Chinese medicine", and only used as prescription medicine for clinical use of traditional Chinese medicine This regulation is very limited to the scope of drug sales Let alone the vast majority of doctors in our country are receiving Western medicine education, even the students of traditional Chinese medicine have many traditional Chinese medicine terms that cannot be fully understood due to the working environment Without Western indications, it's hard to imagine being heavily prescribed For example, at present, the classic prescription compound preparation has not been included in the implementation scope of the listing permit holder system, and the registration applicant can only be a domestic drug manufacturer This has left a large number of research institutions with real strength in R & D in a dilemma, which is likely to affect the implementation effect of this policy In addition, there are many uncertain factors, such as intellectual property protection, medical insurance payment policy, which will also affect the input-output situation of enterprises Therefore, when enterprises intend to invest in this field, they need to carefully examine the pharmaceutical market situation, combine their own characteristics, select a good variety, find partners, and do what they can Original title: application of traditional Chinese medicine classic prescription compound preparation: the business opportunity is very big, and it is not small to teach you to use app (Pharma) in the whole process to seize the business opportunity of pharmaceutical machinery