Medical network - on March 9, the listed Chinese medicine production process change research technical guiding principles draft released on March 6, circle of friends has been refresh, infectious thumb up in succession, seem to be for many years with the "mask" the present situation of the production of traditional Chinese medicine (TCM) seems to have a breakthrough, but how big is the hole? How much Chinese medicine enterprises can drill in the past, I think is still a long way to go, even for many businesses, even with the "guiding principles", may be "dead end".
Chinese traditional medicine production process is not consistent, I believe that is the pain of all the traditional Chinese medicine enterprise, no matter big small business enterprises? Regardless of the sales value of 10 billion or 1 million? I think every enterprise can exist in more or less, just change over the years slam shut, lead to many enterprises "records" into a normal state. Formed the so-called "GMP" and "real record" exist for a long time, especially in dealing with GMP inspection, quality personnel in fear, afraid, afraid to have a short legs. Under such background, the 2010 edition of GMP, data reliability, computer system validation various solution emerge in endlessly, although on the surface of a lot of Chinese medicine enterprises are in rectification, even have Chinese traditional medicine enterprises onto the road of the so-called automatic, digital, intelligent, but the actual conditions, each Chinese medicine enterprise affair.
Right now, for the listed Chinese medicine production process change research technical guiding principles, despite the advice, but after all, gave a direction, an important step, draft I think writing is very good: both macroscopic and microscopic, both general and specific, both general and individual character... Especially following the provisions of the necessity, the principle of scientific, rational, safe and effective, the principle of quality control, quality is the result of design research train of thought, establish a comprehensive system of quality risk management system, set up the equipment is the concept of service for drug quality, such as these is eternal research topic, each Chinese medicine enterprises are forever striving for a goal.
, no matter what kind of change should not be causing obvious changes in drug safety, efficacy. This is the guiding principle in the original sentence is given. Note that should be "obvious" said here is not change, that is "not clear" about the safety and effectiveness of changes, or acceptable. Here to remind: enterprise own research conclusion must have no obvious change for efficacy and safety. If the review staff think you has obvious change to the effectiveness and safety, that can please review data and evidence, I would like to review staff will not be able to take out counter data and proof, so you said there was no significant change for safety and effectiveness, that is no obvious change.
Read the "guidelines" change classification, from medicine to handle change before change to the molding process change, extraction and purification, are made of three categories:
Type I belong to small change, the change does not cause the change of the medicinal material foundation, the absorption and use of the drug does not produce significant effect;
Ⅱ class belongs to the moderate changes, the change of medicinal material base or the absorption and use of drugs, but little change;
Ⅲ class belongs to the significant changes, the change will cause the obvious change of medicinal material base, or the absorption and use of drugs may produce significant effect.
About classes and class Ⅱ I change, is each enterprise will exist for a long time, shot in the rate can reach almost 100%, but these changes had already got a temporary solution through various methods, such as the one called "records do not reflect", good practice also has to the local drug regulatory departments for the record, organize production according to the record after change process, anyway, GMP inspections will not "dead dig" commonly when your registration process and the actual difference.
About Ⅲ class change, is to make the enterprise very sad, and then take the process of diacolation and how many companies in reflux extraction instead of "diacolation," this is a typical Ⅲ class changes, even if companies willing to spend money to take the time to do earnestly, the change process research, process validation and test data, the quality standard study, comparative study on the quality, stability, pharmacology and toxicology studies, clinical trials or bioequivalence study... . This series of "scientific research", hundreds of generic drug for dozens of varieties of traditional Chinese medicine enterprise, estimated to sell medicine earn enough to support the basic fee of these studies. Not to be, may be a dead end; To do it, may also have no choice.
For Chinese traditional medicine enterprises, these are not the most difficult, even if enterprises willing to spend heavily to seriously do change process research, according to the research materials stipulated in the guidelines, all do come down, even at no cost, on time, the fastest years are needed? Time and money spent, still not sure whether changes can pass. I think for most varieties of traditional Chinese medicine (TCM), the boss is hard to make these costs. Ending may go away again, staying the same, to continue with the "mask" the production of traditional Chinese medicine (TCM).
First of all, "process verification", if you really in accordance with the instruction of the "four most strict" spirit, I say 100% are probably overstated, but 90% of Chinese medicine enterprises are doomed, then stop production varieties, carried out in accordance with the "guiding principles" process change research, it is a "fast knot". Stop production, no profit, which come of profits to do research? Ending, maybe it's go away, to maintain the status quo.
Above statement as I imagine, please don't reserved seats, if you have the same coincidence, then, said to "draft" some personal ideas, Suggestions, we are serious:
1, clear local regulatory records, make enterprise can see Chinese medicine, such as for class I and class Ⅱ changes, the enterprise is located, regulators must accept put on record, and can the inspection, the supervision department to remove "mask", under the supervision of production, truthfully record according to the facts; (because you accept for the record companies are so production, you don't accept the record companies are "stealing" production, in fact, the result is the same, so it is better to open a mouth, give a chance to mend)
Real production records after 2, for the record, the enterprise, also avoid the scary, scary, but more conducive to subsequent research of technological change. In the production process of continuous research, improve the process, the accumulation of data, stability test, should do what do what, conditions are ripe, report data, after go approval process;
3, now there is a phenomenon in some places, local regulators to provincial supervision department, the provincial supervision department on national regulators... Layers of shuffle, enterprise dilemma, this problem, must give clear requirements from the executive order, shall not excuse the dispute;
4, in the face of mistakes, accept the reality, technology and equipment, is constantly progress and improve, along with the social development still adhere to the "registration" process must be more than 10 years ago ", for "itself is not scientific, the original declaration process research data is less, especially for Chinese traditional medicine, I have seen most of the traditional Chinese medicine decoction first decoct is 2 hours, with what?
5, the extraction and purification process of traditional Chinese medicine (TCM), is the study of don't know, understand, that is not the traditional Chinese medicine. Not everything can be explained by science, otherwise there would be no philosophy.
Traditional Chinese medicine extraction and purification, it is difficult to use so many perfect principles to requirements, many policy starting point is good, just some to too fast too fast, when a person to also cannot achieve, may also lack of efforts to get the power, let it be, love zha zha ground!!!!
Consistency evaluation + process verification, process changes, the combination play out, how many Chinese medicine enterprise it? |
