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Recently, the Combination Fist of the State Administration of Food and Drug Administration, roaring! In the circulation industry overhaul at the same time, on August 11, the State Administration of Food and Drug Administration issued the "announcement on the implementation of drug production process verification work (draft for comments)," adding a production process verification of the draft for comments, 30 days of enterprise verification for the record, in November began flying inspection.
from the state's regulatory thinking, this regulation is no problem. But for the production of Chinese medicine, raw hard set GMP can not be achieved, the complete implementation of the words, 80% of the enterprises will die, and even evolved into a vigorous campaign to eliminate Chinese medicine preparation enterprises ...
The extraction of medicinal herbs can not be exactly the same reality, the country should manage the quality results or process standards?
I have speculated that the regulatory authorities this time the introduction of production process verification, but also has its industry background. For example, A gum, in accordance with national quality standards, horse skin, pig skin, mule skin and other production of glue, testing is qualified, only the process standards to know what raw materials are used to produce. Historically, the "apple skin" event, is to drill the process standards of the empty, according to the finished product testing is a qualified product.
so, this time the management idea is no problem, but raw hard-nosed GMP on the production of Chinese medicine is not realistic.
this way, at least 80% of traditional Chinese medicine will become a true "fake medicine", because according to the process standards of production, it is almost impossible to produce a full standard of traditional medicine. Because, even in accordance with the management of GAP cultivation herbs to achieve, the problem of Chinese medicine preparation is still not resolved.
, a professor at the Chinese Academy of Military Sciences, said: I discussed the existence and recommendations of the chapter I was involved in writing in my forthcoming book,
20 Years of Modernization of Traditional Chinese Medicine." From the point of view of material composition or composition, the quality of a herbal medicine must be macro-relatively equal and micro-absolutely uneconomic. The composition content of one or more indicators cannot characterize all of its mass characteristics. Therefore, based on the composition will definitely change within a certain range of multiple herbs, it is not possible to use a completely fixed process to produce the same quality of products.
that is to say, the extraction content of each batch of medicinal herbs is not the same, climate change can not guarantee the same, strictly in accordance with the process of production, can not solve the problem of the quality of the finished drug products consistent.
it feasible to modify the production process?
in the draft, mentioned that the production process changes, allowing enterprises to report changes, which is a major step forward for the Ministry of Supervision. Of course, the declaration must provide a basis, you have to re-do quality and stability in the possible basis.
but paradoxically, does this seem to mean that it must be admitted that companies have always been false records? The problem of material extraction is that the purchase of medicinal herbs can not meet the requirements of the process of the Taoist herbs? Do I have to secretly add processing to every sampling failure? You don't know anything, you can't say anything! Because, said is another case to deal with the quality of the accident.
, as mentioned above, how to ensure the quality of Chinese herbal medicine is consistent, which is even after the production process can not be modified to solve the problem.
enterprises to build their own production base crazy?
, when I talked to the regulatory authorities about the above issues, the leader talked to me about the PRODUCTION company GAP. I know that can not talk about, each enterprise to build a base for the cultivation of Chinese herbal medicine is simply not realistic, because the Chinese medicine ingredients need to be all over the country, if in accordance with the requirements of authentic medicinal herbs, how many planting bases do enterprises need to build? But self-built production base is not a day's work, in the short term, Chinese medicine enterprises can only stop production?
If the strict implementation of traditional Chinese medicine this time if the production of process verification standards, due to unstable content, product quality is over, the efficacy of traditional Chinese medicine will once again be questioned by the clinical application of Western medicine and disease.
era of big shuffles is coming!
can focus on the approval number, a year to approve more than 10,000 new drugs on the market, it is time to come out to pay off the debt.
Zheng Xiaoxuan era gave pharmaceutical companies the opportunity to explode, leading China's pharmaceutical industry to grow brutally to more than 6000 production enterprises, "scatter, messy, poor" everywhere. Some enterprises have an exclusive product, through high gross margin space can quickly grow into an enviable enterprise.
this time it's a one-off solution to the problem, with only 30 days to ask for advice. So, strictly speaking, this is a reshuffle process, god medicine and stick will be beaten back to the original shape, which is a strict regulation of pharmaceutical companies is a major good!
For the State Bureau to adopt regulatory policies, we actively agree, but also hope that Chinese medicine as a national strategy, or should do a good job of top-level design, so that enterprises follow the right direction to develop, which is related to the future of the Chinese medicine industry. (Seber Blue)