Behind a regulatory announcement is a life-and-death transformation of an industry and a turning point in my 10-year career.
"A batch of traditional Chinese medicine injections with uncertain efficacy, significant adverse reactions, and unclear risks may be completely withdrawn from the market." In October 2025, when three government departments jointly issued the "Announcement on Further Promoting Post-Market Research and Evaluation of Traditional Chinese Medicine Injections by Marketing Authorization Holders," I was anxiously awaiting experimental results in a pharmaceutical company's laboratory.
As a research and development staff who has worked in the traditional Chinese medicine injection industry for ten years, I know the weight of this announcement--it is not only an upgrade of regulation, but also a turning point for the fate of the whole industry.
01 Industry reality: The harsh winter has arrived, with the market and regulation under double pressure
Chinese herbal injections, a product born in a special historical period of lack of medicine and drugs, have always been the focus of controversy in the pharmaceutical industry. It has created a remarkable sales miracle, but also carries heavy safety doubts.
I still remember the "deadly fish mint injection incident" in 2006, which was a profound professional case in my college days. I did not expect that it would become a warning for me to constantly reflect on my career.
Data show that China has approved more than 130 kinds of traditional Chinese medicine injections, and most of these products were listed in the early stage of the relatively loose drug evaluation environment.
Under policy pressures including medical insurance cost control, the inclusion of auxiliary medications in the list, and revised drug instructions, the market space for traditional Chinese medicine injections has been significantly compressed. Data from Yaorong Cloud shows that hospital sales of TCM injections dropped from 88.058 billion yuan in 2016 to 40.614 billion yuan in 2022, marking a more than 50% reduction in market size. According to Yaozhi Network, since 2017, sales of TCM injections in terminal hospitals have shown an overall downward trend. Hospital sales reached 69.151 billion yuan in 2017, but only 40.38 billion yuan in 2024, with an average annual compound growth rate of-7.4%.
The winter for enterprises has arrived. In 2025, Dali Pharmaceutical, the first company to be delisted, was a traditional Chinese medicine injection enterprise, whose main products were Xingnaojing Injection and Shenmai Injection.
Due to the sharp decline in sales of the two drugs and the company's poor performance, Dali Pharmaceutical was suspended from trading on February 10 as its total market value fell below 500 million yuan for 20 consecutive trading days, becoming the first company to trigger delisting this year.
Longjin Pharmaceutical, formerly a leading company (stock code: *ST Longjin), has also issued a delisting risk warning.
Yibei Pharmaceutical's core product, Aidi Injection, was forced to halt production due to manufacturing issues in the first half of the year, resulting in a loss of 23.846 million yuan. Meanwhile, Hongri Pharmaceutical's net profit attributable to shareholders for the first nine months of 2025 dropped by 52.03% year-on-year.
The plight of these enterprises is just a microcosm of the current situation of the whole industry of Chinese medicine injections.
02 Regulatory Reform: Establishing a Mechanism from "Loose Access" to "Strict Exit"
Over the past decade, I have witnessed firsthand the evolution of the regulatory landscape. Authorities have established a comprehensive regulatory framework, encompassing in-hospital use, medical insurance reimbursement, and drug registration.
Since 2015, the 'key monitoring of adjuvant drugs' has been fully implemented. In 2017, the new version of the medical insurance catalog imposed strict reimbursement restrictions on 39 traditional Chinese medicine injections for the first time. In 2019, the first batch of national key monitoring rational drug use catalog was released.
The October 2025 announcement titled 'Notice on Further Advancing Post-Market Research and Evaluation for Traditional Chinese Medicine (TCM) Injections by Marketing Authorization Holders (Draft for Comments)' marked the industry's most comprehensive regulatory overhaul. It stipulates that TCM injections will be subject to enhanced oversight under the principle of' proactive evaluation of some batches, mandatory evaluation of others, and legal elimination of non-compliant batches'.
The marketing authorization holder shall actively carry out post-marketing research and evaluation, deeply study the material basis and mechanism of action related to clinical efficacy, confirm the safety and effectiveness of the product, and improve the quality control.
For varieties for which there is evidence that the safety or effectiveness data is insufficient, and the existing standards are difficult to ensure the quality stability and control, the NMPA will suspend production in accordance with the law and order the holder to carry out research and evaluation.
If the efficacy is uncertain, the adverse reactions are large or the health of the human body is harmful, the drug registration certificate will be cancelled.
Varieties that have not been produced for a long time shall complete research evaluation and be approved that the benefits outweigh the risks before being marketed again; those who have not obtained the approval for re-registration shall have their registration certificates cancelled.
This means that the focus of regulation has expanded from purely safety issues to higher requirements for effectiveness verification and whole-process quality control.
03 Policy opportunities: Survival of the fittest, the industry is moving towards benign development
The logic of tightening regulation is not to emphasize restriction and elimination, but to gradually build a benign incentive mechanism of survival of the fittest.
Shi Tianyi, a senior consultant at Hejun Consulting, noted that while setting strict evaluation criteria and clarifying the risks of elimination, the policy actively provides tangible policy support such as "accelerated review" for qualified enterprises.
This clear orientation of "rewarding the good and punishing the bad" aims to encourage and guide enterprises to actively carry out technological upgrading and product improvement, transform regulatory pressure into endogenous motivation to improve product quality, and promote the whole industry to a high-quality and sustainable development path.
In addition to strengthening supervision, the draft also specifies a number of supportive and encouraging measures.
For registration applications and communication applications related to post-marketing research and evaluation of Chinese herbal injections, a separate sequence will be established to speed up the review and approval process.
For varieties whose benefits outweigh the risks, the approved drug registration standards will be prioritized for conversion into national drug standards, and the review process will be accelerated if the formulation or revision of national standards is involved.
These measures are undoubtedly a great benefit for enterprises that have always paid attention to product quality and research and development.
In recent years, the company I work for has invested a lot of money to build intelligent production lines and realize the whole life cycle information traceability system from "field" to "bed", which makes it possible for us to stand out in this round of reshuffle.
04 Challenges: The dual challenges of technical bottlenecks and cost pressures
The post-marketing research and evaluation of Chinese herbal injections is by no means easy, and we are faced with many technical bottlenecks.
The complexity of components is the primary challenge. Unlike chemical injectables, traditional Chinese medicine injectables are complex systems with multiple components and multiple targets. In-depth research on the material basis and mechanism of action related to clinical efficacy requires the application of cutting-edge technologies and a large number of resources.
The production of traditional Chinese medicine (TCM) injections must adhere to Good Agricultural Practices (GAP) standards for medicinal materials, which imposes stricter quality control requirements on raw materials. GAP establishes rigorous standards for every stage—from environmental conditions and cultivation practices to harvesting, processing, packaging, and storage—demanding a complete overhaul of the entire supply chain.
High investment in research is also a practical problem that enterprises have to consider. After the completion of market research and evaluation of a variety, tens of millions of yuan or even higher funds are needed. For products whose sales scale has shrunk significantly, the input-output ratio is an important consideration for enterprise decision-making.
Chen Jie, deputy general manager of Sunshine Nuohe Traditional Chinese Medicine Division, proposed that before carrying out post-marketing research and evaluation of traditional Chinese medicine injections, enterprises should first conduct self-assessment to predict whether the products can meet the clinical safety and effectiveness standards, and whether it is worth investing in post-marketing research and evaluation under the current sales scale.
If the evaluation is difficult to meet the target, or the input and output are difficult to match, the cancellation of the approval should be the final result.
Furthermore, the "Special Regulations on the Supervision and Administration of Traditional Chinese Medicine Production" have imposed stricter requirements on the manufacturing of TCM injections. Before resuming production, manufacturers must complete post-market research and evaluation as mandated and submit supplementary applications. For commissioned production of TCM injections, the new regulations explicitly require that both the manufacturer and the entrusted production enterprise's production managers, quality managers, and quality authorized persons must possess at least three years of practical experience in TCM injection production and quality management. These provisions have undoubtedly raised the production threshold for TCM injections, potentially forcing a number of small and medium-sized enterprises to exit the market due to their inability to meet the requirements.
The industry has begun a shakeout, and my pharmaceutical company is no exception. The management has been holding meetings for days to discuss the future of our flagship product—a traditional Chinese medicine injection that once had annual sales of over $1 billion.
Looking at the busy young colleagues in the laboratory, I seem to see myself ten years ago. After the storm of regulation, what will be left is more standardized, more evidence-based and more clinically valuable varieties of traditional Chinese medicine injections.
The future of the industry will belong to those enterprises who respect science, pay attention to quality and have the courage to innovate.
reference material ：
1. Huaxia Times: Chinese herbal injections face the toughest regulatory scrutiny, accelerating industry consolidation. https://www.chinatimes.net.cn/article/148687.html.
2. General Office of the National Medical Products Administration (NMPA), "Announcement on Further Advancing Post-Market Research and Evaluation of Traditional Chinese Medicine (TCM) Injections by Marketing Authorization Holders (Draft for Comments)". https://www.nmpa.gov.cn/xxgk/zhqyj/zhqyjyp/20251009154922152.html.
3. China Food and Drug Network, Series Talk (6) | Strict supervision of key varieties to prevent, manage, and control quality and safety risks. http://www.cnpharm.com/c/2025-09-18/1081024.shtml.
4. Interface News. Traditional Chinese medicine injections face a 'mass phase-out' era. https://www.jiemian.com/article/13449768.html.
5. China National Medical Products Administration (NMPA), "Special Provisions on the Supervision and Administration of Traditional Chinese Medicine Production". https://www.nmpa.gov.cn/xxgk/fgwj/xzhgfxwj/20250908094819150.html.
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