Recently, the State Food and Drug Administration issued "Several Measures on Further Strengthening the Scientific Supervision of Chinese Medicines and Promoting the Inheritance, Innovation and Development of Chinese Medicines", the "Measures" proposed: promote the improvement of the production and operation mode of Chinese medicine pieces, urge Chinese medicine formula granule manufacturers to produce in strict accordance with the recorded production process, strictly review suppliers, and strengthen the quality management
of the whole link such as identification of Chinese medicinal materials, processing of Chinese medicine pieces, granule production, inspection and release.
At the same time, it is mentioned that the supervision and inspection of Chinese medicine pieces, Chinese medicine formula granules and Chinese proprietary medicines will continue to be strengthened, and the extended inspection
of Chinese medicinal materials will be carried out in an orderly manner.
Further standardize the circulation and operation order of Chinese medicine pieces, Chinese medicine formula granules and proprietary Chinese medicines, and strengthen the quality supervision
of the use link.
From the above "measures", in 2023, the traditional Chinese medicine formula granule industry will face stricter supervision, forcing traditional Chinese medicine formula granule enterprises to continuously improve production processes and improve product quality, and the industry will further develop
in the direction of standardization.
In 2023, the traditional Chinese medicine formula granule industry will face stricter supervision! (Image source: Pharma Network)
The traditional Chinese medicine formula granule industry will enter a period of rapid growth
Chinese medicine formula granules are the product of Chinese medicine pieces adapting to the development of modernization, which are granules made of single flavor Chinese medicine pieces through a series of processing processes such as water extraction, separation, concentration, drying and granulation, which need to be prepared under the guidance of Chinese medicine theory and according to the clinical prescription of Chinese medicine for patients to take and use
.
In recent years, with the aging of the population and the continuous upgrading of consumption, traditional Chinese medicine formula granules have been favored by the market for their advantages such as convenient consumption, and the scale of the industry is also expanding
.
Southwest Securities revealed in a research report that the market size of traditional Chinese medicine formula granules increased from 10.
7 billion yuan in 2016 to 25.
5 billion yuan in 2020, and it is expected that the replacement rate of formula granules will be about 50% in the future, and the market of 100 billion yuan will be opened in the future
.
According to Huaan Securities, by 2030, the market size of China's formula granules will reach 110.
2 billion yuan, and the penetration rate will increase to the range
of 25%-35%.
In February 2021, the "Announcement on the End of the Pilot Work of Traditional Chinese Medicine Formula Granules" was released, which pointed out that since November 1, 2021, the pilot work of traditional Chinese medicine formula granules has ended, and the filing system has been officially implemented, which means that after more than 20 years of piloting, traditional Chinese medicine formula granules have been fully liberalized, and enterprise production has a "national standard"
.
At present, traditional Chinese medicine formula granules are accelerating the switch and upgrade to the national standard, and as of the end of September 2022, three batches of national standards have been promulgated, totaling more than 200 varieties, in addition to 69 variety standards in the public stage
.
At the same time, provincial standard varieties in various provinces are also accelerating the filing process, including Hubei, Beijing, Zhejiang, Jiangsu and other provinces and cities have successively issued local traditional Chinese medicine formula granule quality standard announcements or publicity
.
In this context, a large number of pharmaceutical companies, including Red Sun Pharmaceutical and Yiling Pharmaceutical, have actively deployed on the track of traditional Chinese medicine formula granules, carrying out national and local formula granule standard research and application work, in order to share the market cake
.
Affected by the progress of the switch, the performance of related formula granule companies in 2022 has been affected to a certain extent, but in the long run, most of the layout enterprises are full of confidence in future growth, such as CR Sanjiu expects that the formula granule business will be in a period of rapid growth in the next one or two years after the policy is liberalized, under the background of medical insurance support and market expansion
.
Broad access also requires strict supervision
With the liberalization of policies, formula granule manufacturers have changed from a license system to a filing system, and the market allows new enterprises to enter production, and the industry may appear to develop in disorderly order, excessive drug abuse and other problems, so strict supervision is also needed to ensure the standardized development of
the industry.
Both the national and provincial standards of traditional Chinese medicine formula granules put forward high requirements for the production of traditional Chinese medicine formula granules, including: the quality of traditional Chinese medicinal materials used in production must be much higher than the lower quality limit of medicinal materials stipulated in the 2020 edition of the Chinese Pharmacopoeia; Clearly define the range of active substance content; Strict requirements have also been set for the content of harmful substances
.
The introduction of the new "Measures" has put forward strict requirements for the production process of traditional Chinese medicine formula granule enterprises, which will force enterprises to standardize their development and operation, which is conducive to further promoting the high-quality development of the traditional Chinese medicine formula granule industry.
In August 2021, the National Health Insurance Administration said in its response to the "Proposal on Accelerating the Centralized Procurement of Traditional Chinese Medicine and Formula Granules" that it would accelerate the inclusion of proprietary Chinese medicines and formula granules in centralized procurement
.
In March 2022, Shanghai Sunshine Pharmaceutical Procurement Network issued the Notice on Publishing the Dynamic Adjustment of the Procurement Information of Some Chinese Medicine Tablets and Chinese Medicine Formula Granules, and then Hunan, Shandong, Fujian, Hainan and other provinces and cities also issued relevant notices
on the online procurement of Chinese medicine formula granules.
The industry believes that with the landing of online procurement in various provinces, traditional Chinese medicine formula granules may also face pressure in terms of cost control and quality, and enterprises with layout need to make certain preparations
.
epilogue
Overall, with the expansion of the product sales scope of the former provincial pilot enterprises to the whole country, the entire traditional Chinese medicine formula granule industry will be more active, at the same time, the market competition will be more intense, and enterprises will face stricter requirements and more intensive supervision
.
Guangdong Securities pointed out that traditional Chinese medicine formula granules have the characteristics of controllable quality standards, flexible composition and easy management, but also require a higher level of technical technology, traditional Chinese medicine formula granules are currently in the initial stage of development, participating in the formulation of national standards and enterprises with advanced technology have the right to speak, and are expected to continue to share the growth dividends
of the industry.
Disclaimer: Under no circumstances does the information or opinions expressed herein constitute investment advice
to anyone.
={"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)]; 
