Detailed rules for supporting traditional Chinese medicine formula particles have been issued in many places, and pharmaceutical companies will welcome new opportunities

In recent years, with the widespread application of traditional Chinese medicine formula particles, both the country and the locality have been accelerating its larger-scale opening up
.
In particular, since February this year, the State Food and Drug Administration, the National Medical Insurance Administration and other four departments issued the "Announcement on Ending the Pilot Work of Chinese Medicine Formula Granules" (referred to as the "Announcement").
For example, Jiangsu Province, Guizhou, Jiangsu, Shaanxi, Yunnan, Guangdong and other provinces have successively issued the working procedures for formulating the quality standards of traditional Chinese medicine formula granules and the requirements for application materials, and are actively implementing the accelerated and standardized development of the Chinese medicine formula granule industry
.
The market for traditional Chinese medicine formula granules continues to expand, and pharmaceutical companies will welcome new opportunities (picture source: Pharmaceutical Network).
For example, on October 21, the Jiangsu Provincial Food and Drug Administration issued the "Rules for the Management of Jiangsu Province Traditional Chinese Medicine Granules", which clearly stated that pharmaceutical manufacturers are The main body responsible for the production and quality assurance of Chinese medicine formula granules; pharmaceutical manufacturers should log in to the "Chinese medicine formula granule registration management module of the drug business application system of the State Food and Drug Administration" (hereinafter referred to as the Chinese medicine formula granule registration platform), in accordance with relevant regulations, in the Chinese medicine formula granule The filing platform uploads relevant materials; the production process and drug standards shall also be carried out in accordance with the filing production process and drug standards
.
On September 7, Hebei Provincial Drug Administration also took the lead in drafting the "Rules for the Implementation of Hebei Province Traditional Chinese Medicine Formula Granule Management" (draft for comments)
.
Among them, specific requirements are put forward for many aspects such as production management, use management, drug standards, and filing
.
The industry believes that under the influence of the country's continuous progress in the construction of relevant standards for traditional Chinese medicine formula granules, and the influence of various provincial drug regulatory departments in stepping up the formulation and release of relevant standards for Chinese medicine formula granules, strict standard formulation and in- and post-event supervision will be indispensable in the future
.
In this context, manufacturers need to fulfill the main responsibility and related obligations of the whole life cycle of drugs in the future, strengthen management and control in the production and management process, and ensure the quality and safety of traditional Chinese medicine formula particles in order to better assist the industry.
healthy growth
.
It is understood that in order to further ensure product quality and safety, a Chinese medicine formula granule company has long been equipped with high-phase liquid chromatographs, gas chromatographs, atomic absorption spectrometers, ultraviolet-visible spectrophotometers, etc.
in the quality inspection center in the production workshop.
Precise laboratory analysis and testing equipment to meet the full inspection of Chinese medicinal materials, Chinese medicinal pieces, Chinese medicinal formula granules and other products
.
In addition, more and more traditional Chinese medicine companies have begun to abandon the traditional backward pharmaceutical technology and equipment, and then use professional intelligent, automated, and digital equipment to promote the development of the industry with higher quality
.
In this regard, the industry believes that the entire pharmaceutical equipment industry will also usher in new development opportunities
.
Especially in the context of incorporating intelligent manufacturing concepts into the pharmaceutical process design, using intelligent pharmaceutical equipment to improve the automation of the pharmaceutical workshop, it will be of great significance to the high-quality development of the current Chinese medicine formula granule industry
.
In fact, as far as the author knows, in the field of Chinese medicine, more and more Chinese medicine pharmaceutical equipment companies have begun to abandon the traditional backward pharmaceutical technology, and are constantly developing more professional intelligent, automated, and digital equipment to help.
Development of Chinese medicine industry
.
For example, in the research of intelligent Chinese medicine extraction equipment, Canaan's scientific and technological performance has been relatively active
.
It is reported that it has invested a lot of money to build 3 intelligent Chinese medicine extraction equipment production lines that can provide customized products for customers
.
The production line is composed of four parts: intelligent production control center, intelligent processing production line, intelligent monitoring and analysis center.
It mainly produces and develops intelligent Chinese medicine extraction equipment.
It is expected to produce 90 sets of Chinese medicine extraction equipment per year
.
In general, with the continuous expansion of the market scale of traditional Chinese medicine formula granules, related pharmaceutical equipment in the traditional Chinese medicine industry chain will have a broader space, which has become a consensus in the industry
.
But it should be noted that improving and innovating equipment structure and technology is still what the current pharmaceutical equipment companies need to do
.
Because only with high-quality, advanced technology, and pharmaceutical equipment that meets industry standards, specifications, and market demand, can the Chinese medicine formula granule industry continue to develop in the direction of high quality
.