Recently, on the registration and safety of traditional Chinese medicines, the General Department of the State Food and Drug Administration once again issued the Special Provisions on the Registration and Administration of Traditional Chinese Medicines (Draft for Comments) (hereinafter referred to as the "Special Provisions"
).
It is understood that the provisions have 12 chapters and 87 articles
.
Involving the registration classification and marketing approval of Chinese medicines; rational application of empirical evidence for human use; innovative drugs; improved new drugs; Ancient classic Chinese medicine compound preparation; The same name and prescription drug; post-listing changes; Drug registration standards; Drug name and instruction manual, etc
.
The traditional Chinese medicine market may usher in a reshuffle, and standardized development will become the focus of pharmaceutical companies (Image source: Pharmaceutical Network)
Among them, it is worth mentioning that a provision stipulates that if any of the [contraindications], [adverse reactions] and [precautions] of Chinese medicines is still "unclear" when applying for drug re-registration, it will not be re-registered
.
The industry believes that if the regulations are really implemented, this matter of Chinese medicine instructions will involve a large number of proprietary Chinese medicine enterprises
.
It is reported that for a long time, the revision of the instructions of traditional Chinese medicines will have a lot of direct impact
on pharmaceutical companies.
Some proprietary Chinese medicines involve a wide range of products, and the revision of the instructions will directly affect hundreds of pharmaceutical companies
.
In this context, it may cause a major reshuffle in the traditional Chinese medicine market
.
In this regard, industry analysts believe that for traditional Chinese medicine enterprises, drugs with "unclear adverse reactions to traditional Chinese medicine" cannot survive after that, so enterprises need to do a series of evidence-based research to concretize and standardize the instructions of traditional Chinese
medicines.
In fact, the standardized development of traditional Chinese medicine has always been one of the issues that the state focuses on vigorously developing the traditional Chinese medicine industry, and relevant departments are also frequently issuing policies and strict supervision to promote the standardized and high-quality development of all aspects of production, processing and storage of the traditional Chinese medicine industry
.
Taking production as an example, Chinese medicinal materials are prone to poor pools in the production process and quality control
.
Therefore, in recent years, many departments in China have jointly issued a series of documents such as "National Construction Plan for Local Medicinal Materials Production Base" and "Good Manufacturing Standards for Chinese Materia Medica Materials" to jointly strengthen source management
.
In addition, a series of policies have been introduced successively, increasing the punishment and cost
of enterprises that violate the law.
In this case, the relevant enterprises can only adhere to compliance operations to find the way
out.
In fact, in order to control the quality of Chinese medicines from the source, promote the integrated development of processing and processing of Chinese medicinal materials, improve the market competitiveness of the Chinese medicinal materials industry, promote the high-quality development of the Chinese medicine industry, and improve the quality of Chinese medicinal materials and Chinese herbal tablets, many enterprises have begun to process Chinese medicinal materials in the procurement of production areas to promote the standardization and standardization of processing in production areas
.
It is worth mentioning that in the context of digital transformation has swept the traditional Chinese medicine industry, many traditional Chinese medicine companies are still vigorously using digital technology and equipment to accelerate transformation and upgrading and promote the high-quality development of
pharmaceuticals.
For example, Hanwang Pharmaceutical is continuously improving product quality and expanding the scale
of enterprises by introducing digital traditional Chinese medicine production lines.
It is reported that Hanwang Pharmaceutical has abandoned the traditional production method that consumes manpower and material resources and introduced a complete set of conjoined modern Chinese medicine preparation equipment
.
The fully integrated and automated production workshop not only improves production efficiency, improves product quality, but also further empowers the development of enterprises
.
In addition, Yunnan Baiyao is also using 5G, industrial Internet, big data, artificial intelligence, blockchain and other technologies to create a "digital Sanqi industry platform" to help Yunnan Sanqi industry embark on the road
of standardized and standardized transformation and upgrading.
At present, under the background of multiple measures, the quality of Chinese medicine products, including Chinese medicine pieces, has been significantly improved
.
According to the "2021 National Blue Book of Traditional Chinese Medicine Supervision", in recent years, under the significant improvement and improvement of the control of raw materials, production process and product quality of Chinese medicine pieces, the overall pass rate of Chinese medicine pieces has increased from 77.
7% to 98.
4% from 2016 to 2021
.
Industry analysts believe that a series of policies from the national to the local level are supporting the high-quality development of the traditional Chinese medicine industry, and the supervision of drug safety is becoming stricter, and the demand and technical requirements for traditional Chinese medicine processing equipment will be further improved
in the future.
In this context, for relevant enterprises, it is urgent to study new processes and new technologies to make equipment more efficient and intelligent, so as to further improve the quality and safety
of traditional Chinese medicine.
={"common":{"bdSnsKey":{},"bdText":"","bdMini":"1","bdMiniList":false,"bdPic":"","bdStyle":"0","bdSize":"32"},"share":{},"image":{"viewList":[" weixin","sqq","qzone","tsina","tqq","tsohu","tieba","renren","youdao","fx","ty","fbook","twi","copy","print"],"viewText":"share:","viewSize":"24"},"selectShare":{" bdContainerClass":null,"bdSelectMiniList":["weixin","sqq","qzone","tsina","tqq","tsohu","tieba","renren","youdao","fx","ty","fbook","twi","copy","print"]}}; with(document)0[(getElementsByTagName('head')[0]|| body).
appendChild(createElement('script')).
src='http://bdimg.
share.
baidu.
com/static/api/js/share.
js?v=89860593.
js?cdnversion='+~(-new Date()/36e5)]; 
