How many traditional Chinese medicine enterprises are able to bear the released principles of traditional Chinese medicine production process?

[market analysis of chinapharma.com] on March 6, the draft of technical guidelines for research on production process change of listed traditional Chinese medicine was released, which seems to mean that there is a breakthrough in the current situation of production of traditional Chinese medicine with "Mask" for many years, but how big is it? How many traditional Chinese medicine enterprises can go through? I think there is still a long way to go Even for many enterprises, even if there is a "guiding principle", it may still be a dead end (how many traditional Chinese medicine enterprises are able to bear the released principles of traditional Chinese medicine production process? Picture source: Baidu picture) the production process of traditional Chinese medicine is inconsistent I believe it is the pain of all traditional Chinese medicine enterprises, no matter large or small enterprises? Whether the market value of sales is 1 billion or 1 million? The author thinks that every enterprise will exist more or less, but it has been changing for many years, leading to many enterprises "record fraud" become the normal The so-called "GMP record" and "real record" have existed for a long time Especially when dealing with GMP inspection, the quality personnel of the enterprise are afraid of being exposed In this context, GMP 2010, data reliability, computer system verification are emerging in an endless stream Although on the surface, many traditional Chinese medicine enterprises are rectifying, and even some traditional Chinese medicine enterprises are on the road of so-called automation, digitalization and intelligence, but what's the actual situation? Every traditional Chinese medicine enterprise knows its own way Now, the introduction of "technical guidelines for research on production process change of listed traditional Chinese medicine" has given a direction and taken an important step The author thinks that the draft is well written: both macro and micro, both general and specific, both general and personal In particular, it follows the rules of necessity, scientificity and rationality, the principles of safety, effectiveness and quality control, the research ideas of quality from design, the establishment of a comprehensive and systematic quality risk management system, and the concept that equipment is the service for drug quality These are the eternal research topics of every Chinese medicine enterprise, and a goal that is always striving for No matter what kind of change, it should not cause obvious changes in drug safety and effectiveness This is the original sentence in the guiding principles Note that what is said here is that "obvious" changes should not be caused, that is to say, "not obvious" changes in safety and effectiveness are acceptable Here's a reminder: the conclusion of the enterprise's own research must not significantly change the effectiveness and safety If the reviewers think that you have obvious changes to the effectiveness and safety, they can ask the reviewers to provide data and evidence I think the reviewers can't provide the data and evidence to refute, so you say that there is no obvious change to the safety and effectiveness, that is, there is no obvious change According to the change classification of the guiding principles, three classifications have been made, from the change of pretreatment, extraction and purification of medicinal materials to the change of molding process: Category I belongs to minor change, which will not cause the change of the basis of medicinal materials, and will not have a significant impact on the absorption and utilization of drugs Class II belongs to moderate change, which has an impact on the basis of medicinal substances or on the absorption and utilization of drugs, but little change; class III belongs to major change, which will cause significant changes in the basis of medicinal substances, or may have significant impact on the absorption and utilization of drugs   As for the class I and class II changes, every enterprise will exist for a long time, and the medium gun rate can reach almost 100% However, these changes have been temporarily solved by various methods, such as a kind of "record does not reflect", a good practice also has been filed with the local drug regulatory authorities, and the production is organized according to the changed process after filing, anyway, GMP on-site inspection In general, it will not "cut" the difference between your registered process and the actual process   As for class III change, it is very uncomfortable for enterprises Take "percolation" as the process, how many enterprises are using reflux extraction instead of "percolation", which is a typical class III change Even if enterprises are willing to spend time to do it seriously, change process research, process verification and pilot test data, quality standard research, quality comparison research, stability research, pharmacological toxicity Physical, clinical or bioequivalence studies This series of "scientific research" is not enough to support the basic costs of these researches for the traditional Chinese medicine enterprises that are prone to tens of hundreds of generic drugs If you don't do it, you may die; if you do it, you may have no way to go For the traditional Chinese medicine enterprises, these are not difficult Even if the enterprises are willing to spend a lot of money to do the change process research seriously, according to the research data stipulated in the guiding principles, all of them will be done, even if the cost is not included In terms of time, it is necessary for several years? Time and cost have been spent, and it's not sure if the change will pass I think for most varieties of traditional Chinese medicine, the boss is very difficult to give up these costs The end may be over again, maintain the original, and continue to produce traditional Chinese medicine with "Mask" First of all, if the "process check" is really in accordance with the spirit of the "four strictness" instruction, the author said that 100% may be somewhat exaggerated, but 90% of Chinese medicine enterprises are doomed, and then the production of varieties is stopped, and the process change research is carried out in accordance with the "guiding principles", which is also a "dead end" Stop production, how to make profits, and what profits to do research? The end, perhaps, is to maintain the status quo The above statement is my conjecture Please don't take your seat according to your name It's just a coincidence Next, we'd like to give some personal opinions and suggestions to the draft for comments We are serious: 1 Make clear the filing system of local regulatory authorities, so that Chinese medicine enterprises can see clearly For example, for class I and class II changes, the local regulatory authorities of the enterprise must accept the filing, and can conduct on-site verification, remove the "Mask" under the supervision of the regulatory authorities, and truthfully produce and record; (because you accept the production of the filing enterprises, you do not accept that the filing enterprises are also "stealing" ”In fact, the results of production are the same, so it's better to open a mouth and give a chance to change.) 2 After the record, the real production record of the enterprise also avoids fear and fear In fact, it is more conducive to the research of subsequent process change In the production process, continuous research, process improvement, data accumulation, stability inspection, what to do and what to do should be done When the conditions are mature, submit the data and go through the approval process; 3 Now there is a phenomenon in some places, local regulatory authorities push to provincial regulatory authorities, provincial regulatory authorities push to national regulatory authorities On this issue, we must give clear requirements from the administrative order, and we must not shirk the buck 4 Facing the mistakes, accepting the reality, technology and equipment, with the continuous progress and improvement of social development, we still insist that the "registration" technology more than ten years ago must be "right", which is not scientific in itself In fact, there are fewer research materials to declare the technology at the beginning, especially for traditional Chinese medicine, the author has seen that the decoction of most traditional Chinese medicine is 2 hours, why? 5 The process of extraction and purification of traditional Chinese medicine is not understood by research If the research is understood, it is not traditional Chinese medicine Not everything can be explained by science, otherwise there will be no philosophy It's hard to use so many principles to require the extraction and purification of traditional Chinese medicine Many policies have good starting points, but some of them are too urgent and fast When a person can't achieve it, he may lose the motivation of his efforts Let it be as it is, how can he love it! Consistency evaluation + process verification + process change, how many traditional Chinese medicine enterprises can bear this combination?