The implementation of this new pharmaceutical regulation from July 1 next year may affect the pharmaceutical equipment industry!

Vaccine is a preventive medicine that provides active acquired immunity for one or more diseases
.
In China, due to the huge population base of our country, the increase of the people's disposable income and the increase of people's awareness of vaccination, China's vaccine market has maintained a rapid growth trend, and the overall market scale has continued to expand
.
Data shows that the total scale of the domestic vaccine market has exceeded 50 billion yuan in 2020, reaching 51.
5 billion yuan, and is expected to exceed 60 billion yuan by 2021
.
Pharmaceutical equipment (picture source: Pharmaceutical Network) This new pharmaceutical regulation will be implemented on July 1 next year.
In the face of the considerable market in the vaccine industry, capital and enterprises are accelerating the deployment of the vaccine industry
.
According to the data from the enterprise search, the number of registrations of Miao-related companies has been increasing year by year in the past ten years, and the annual registrations in the past three years (2018-2020) have all been above 1,500
.
Affected by the epidemic in 2020, the number of registrations of epidemic-related companies in China continued to increase.
The number of registrations of vaccine-related companies nationwide was 1,556, a year-on-year increase of 2.
8%
.
In Q1 of 2021, the number of registered vaccine-related companies in China was 176, a year-on-year decrease of 36.
7%
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According to forecasts, China's vaccine-related companies will reach 1,604 in 2021
.
It is worth mentioning that, as a biological product, vaccines have a high technical threshold, a long production cycle, many links, and stricter supervision
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While many companies have deployed in this field and related vaccine companies have increased their production and capacity, the quality and safety of vaccines has also been placed at the top of the list
.
It is understood that in order to implement the "Vaccine Management Law", the State Food and Drug Administration revised and released the biological product appendix of the "Pharmaceutical Production Quality Management Regulations (Revised in 2010)" in April 2020, which clearly requires: vaccine manufacturers should be in 2022 Before July 1, 2015, use information technology to truthfully record all data formed in the production and inspection process to ensure that the relevant data is true, complete and traceable to ensure that the entire production process continues to meet legal requirements
.
In other words, starting from July 1 next year, vaccine manufacturers need to meet the data requirements of the production process to ensure that the production process can be monitored and to ensure the quality and safety of vaccines
.
This will be a big challenge for vaccine manufacturers, and companies that cannot meet the requirements may face the situation of being eliminated
.
Will the pharmaceutical equipment industry be affected? At present, there is only more than half a year left until July 1 next year.
During this time, vaccine manufacturers need to speed up their transformation and upgrading, and transform towards digitalization
.
So, will this have an impact on the upstream pharmaceutical equipment industry? Some investors are also more concerned about this issue.
For example, recently, some investors asked Chutian Technology: "From July 1 next year, the production process of biological products will be digitalized.
For the existing production lines of biological medicine companies, the transformation How difficult is it, will it bring orders for upgrading and transformation?” In response, Chutian Technology replied: This type of transformation business can also be done by some companies that are mainly engaged in information technology, but it is very difficult for these companies because it involves biological Problems in the pharmaceutical process
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He said that Chutian has provided a large number of biological product production lines and overall solutions, and it is easy for Chutian to do this part of the business
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The company has established an AI and information team, the current team size is more than 30 people, and the future plans to be about 200 people (excluding the existing external cooperation team)
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At this stage, the number of renovation orders is not large, but it is expected to increase in the future, and there have been close to 10 million new orders this year
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It can be seen from the above information that Chutian Technology is ready to undertake the informatization transformation business of the biological products industry, and the transformation orders are expected to increase
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The industry pointed out that since 2020, imported equipment has been limited by factors such as delays in delivery, and the space for national replacement of biological medicine equipment has been opened
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In the field of domestically produced pharmaceutical machinery, companies with certain technological R&D capabilities and able to provide overall solutions are expected to demonstrate their competitive advantages and gain new room for growth
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In addition to Chutian Technology, Tofflon, for example, has also grown from a "system solution service provider" to a "smart pharmaceutical factory deliverer"
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In terms of the industrialization of biopharmaceuticals, Tofflon focuses on the construction of an industrialization platform
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The company once stated on the interactive platform that it can not only provide biomedical customers with process equipment, but also provide them with overall solutions (process + equipment + engineering), bioprocess integration and other services
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