With less than two weeks to go before May 1, 2026, the countdown has begun for the implementation of State Council Decree No. 818 – the "Regulations on the Clinical Research and Clinical Translational Application of New Biomedical Technologies."

 

On April 19, the National Health Commission (NHC) published on its official website the "Announcement on Soliciting Public Comments on the Approval Work Specifications for the Clinical Translational Application of New Biomedical Technologies (Draft for Comments)." The deadline for comments is April 25, meaning the industry has only one week to provide feedback.

 

This sense of urgency underscores the need for detailed rules to be in place before the regulations take effect, avoiding an implementation vacuum where "laws exist but no procedures are available."

 

Prior to this, on February 24, the NHC's Department of Science, Technology and Education had already published a rare explanatory article on the commission's website titled "Implementing the 'Regulations on the Clinical Research and Clinical Translational Application of New Biomedical Technologies' to High-Quality Meet the Health Needs of the People and Support Higher-Level Development of the Biopharmaceutical Industry."

 

If that earlier statement was seen by the industry as a proactive stance by regulators to "eliminate information asymmetry and build industry consensus," then this time the NHC has directly produced a concrete plan for the approval process, truly beginning to map out the track.

 

 

TONACEA 01: From a "Document" to a "Law"

 

 

To understand this newly released work specification, one cannot look at it in isolation. Behind it lies an entire timeline of policy evolution.

 

As early as 2015, the former National Health and Family Planning Commission and the former China Food and Drug Administration jointly issued the "Interim Measures for the Administration of Stem Cell Clinical Research," establishing for the first time a management pathway for stem cell clinical research with medical institutions as the responsible entities. In subsequent years, local-level explorations in Hainan, Shenzhen, Hunan, Tianjin, and elsewhere continued to expand.

 

However, the biggest problem was that these policies were either departmental normative documents or local pilot programs. Their legal hierarchy was low, implementation standards varied widely across regions, and there was a consistent lack of a unified legal framework at the national level.

 

In September 2025, Premier Li Qiang of the State Council signed Decree No. 818, officially promulgating the "Regulations on the Clinical Research and Clinical Translational Application of New Biomedical Technologies." The regulation consists of 7 chapters and 58 articles, covering the entire chain of clinical research filing, clinical research implementation, clinical translational application, supervision and management, and legal liability.

 

Academician Huang Xiaojun of the Chinese Academy of Engineering commented that the regulation fills a regulatory void in this field, "marking the entry of China's new biomedical technology development into a new track of legalization and standardization."

 

Liu Zhongmin, Honorary Dean of Shanghai East Hospital affiliated with Tongji University, described it as the first time China has systematically regulated the entire process from R&D to clinical translation of new biomedical technologies such as stem cells in the form of national-level administrative regulations.

 

Under the overarching framework of Decree No. 818, this approval work specification issued by the NHC on April 19 becomes a critical "piece of the puzzle." It stipulates who can apply for translation, whom to apply to, what materials to submit, what procedures to follow, and how long it will take to receive a response.

 

In other words, without this detailed specification, the "approval for clinical translational application" in the regulation would remain merely a legal concept, difficult to operationalize.

 

 

TONACEA 02: What Does the Work Specification Stipulate?

 

 

This newly released draft for comments involves five key points.

 

First, the threshold. Not every technology can take this path. Only two categories of technology are eligible: either those with a high degree of personalization for which there is no domestic product with a similar mechanism of principle already on the market or in confirmatory clinical trials; or those treating rare diseases for which no similar drug is on the market.

 

Drugs and medical devices that already have a product form and can be standardized and mass-produced must return to the NMPA's registration pathway.

 

The drafting note specifically explains this logic: the aim is to promote "synergistic and complementary development" between new biomedical technologies and the biopharmaceutical industry. In other words, the NHC's approval pathway is a channel reserved for technologies that either "cannot be made into drugs" or for which the "drug pathway is too long."

 

As for how "similar mechanism of principle" is defined, it will vary by technology type, with separate guidelines to be formulated later.

 

Second, multi-center independent verification is not just a talking point.

 

Article 6 of the work specification explicitly lists "consistent multi-center independent verification" as a condition for application. In other words, completing a filed clinical study at one's own institution is insufficient. The technology must also be independently implemented by other qualified medical institutions and health professionals following operational standards, yielding consistent conclusions on safety and efficacy.

 

This is not a superficial parallel verification, but a substantive test of reproducibility. This threshold alone is enough to exclude many technologies that rely heavily on the personal experience of "star doctors."

 

Third, the approval process has a timeline, but the real challenge lies in the evaluation stage.

 

Articles 8 through 17 of the work specification outline a clear approval pipeline: formal review (correction or acceptance within 5 days) → transfer to a professional agency (within 5 working days of acceptance) → expert evaluation (material review + technical and ethical assessment) → NHC makes an licensing decision (within 15 working days of receiving the evaluation opinion).

 

In theory, the total timeframe is controlled at around 20 working days—an aggressive pace in the field of administrative licensing. However, the real variable is the expert evaluation stage.

 

Article 12 of the work specification grants evaluating experts considerable discretion: they can conduct reviews by correspondence, conference, or on-site; they can seek opinions from drug regulatory authorities; and they can even directly issue an evaluation opinion to "terminate the review."

 

Fourth, approval is not the end; it is the starting point for even stricter oversight.

 

This is the most easily overlooked provision in the work specification, yet it has the most profound impact on the industry: Article 20. It classifies technologies into three risk levels—high, medium, and low—and then sets corresponding "protection periods" during which the technology can only be used by the original research institution: 5 years for high risk, 3 years for medium risk, and 1 year for low risk.

 

Before the expiration of this period, only the clinical research institution that developed the technology (including multi-center sites) may use it. After the period expires, other qualified institutions and personnel may only enter the field if no re-evaluation circumstances have occurred, or if re-evaluation confirms that the benefits far outweigh the risks.

 

Fifth, re-evaluation can suspend use at any time.

 

Article 23 of the work specification stipulates four circumstances under which the NHC will organize a re-evaluation, during which application of the technology will be suspended. These include: changes in scientific understanding, occurrence of serious adverse reactions, or causing significant social stability risks.

 

Re-evaluation looks not only at safety and efficacy but also includes a health economics assessment, comparing the technology with drugs and medical devices indicated for the same condition. Experts who participated in the original approval must recuse themselves. This design means that even after approval, the technology is not permanently secure. If a superior drug comes to market later, or if the technology reveals new risks, it may be suspended or even prohibited at any time.

 

 

TONACEA 03: Industry Reaction – Who Cheers, Who Trembles

 

 

When the news broke, the industry's reaction was predictably divided.

 

For leading companies and large tertiary hospitals (Grade 3A), this represents the final step of policy dividends moving from paper to reality. The regulation explicitly stipulates that institutions conducting clinical research on new biomedical technologies such as cell therapies must be Grade 3A medical institutions, and must have qualified academic and ethics committees.

 

In other words, the status of Grade 3A hospitals within the entire industrial chain is institutionally elevated. As of December 2025, 33 Grade 3A hospitals in China had established Cell Therapy and Regenerative Medicine Centers, actively entering the field.

 

Huangpu District in Guangzhou is already taking action. On April 10, the district established the Guangzhou Development District Biomedical New Technology Clinical Research and Translational Application One-Stop Service Center, the first public service platform for Decree No. 818 in Guangdong Province and even South China to be established by a district- or county-level health administrative department.

 

For Huangpu, the implementation of the regulation extends certain activities previously permitted only in Free Trade Zones to the entire country. The district is home to more than 4,800 biomedical enterprises, 21 listed companies, 154 CGT-related enterprises, and 18 research hospital alliance members. It is transitioning from a "large-scale district" to a "high-quality district."

 

Shanghai's Pudong New Area is also accelerating. Recently, the Zhangjiang Pharma Valley International Innovation Conference and the 2026 Shanghai Stem Cell Industry Conference were held in Pudong. Pudong has produced China's first gene therapy product and has four marketed CAR-T products, accounting for half of the national total. Just before the conference, China's third stem cell Drug Manufacturing License was issued in Zhangjiang Pharma Valley.

 

These signals collectively point to a trend: policy implementation is accelerating the concentration of resources toward leading regions and enterprises. However, for small and medium-sized enterprises that have long operated in gray zones, the situation is far less optimistic.

 

The new regulation explicitly prohibits charging subjects any form of fee during the clinical research stage, and for the first time designates medical institutions and their medical staff as directly responsible entities. Penalties for violations are severe: institutions that conduct research without filing will be fined RMB 200,000 to 1 million; primary responsible persons will be barred from engaging in related clinical research activities for five years.

 

Industry observers直言 that the triple threshold—partnering with Grade 3A hospitals capable of technology filing, investing sufficient clinical research funds, and providing services free to subjects—will likely keep 80% of cell therapy companies out of the market.

 

The dual-track development pathway has also been thoroughly clarified in this process. The revised "Implementation Regulations for the Drug Administration Law" (Decree No. 828), effective January 2026, further clarifies the pharmaceutical pathway for cell therapies.

 

Together, the two administrative regulations delineate a clear compliant development pathway: either pursue the drug registration and marketing route, investing heavily to meet CMC and clinical requirements; or take the medical technology translation route, deeply binding with Grade 3A hospitals and becoming their technology service provider.

 

 

TONACEA 04: Rules Are Clear, But Questions Remain

 

 

The release of the work specification has answered many questions, but some unresolved issues remain.

 

The biggest unanswered question is the specific criteria for risk classification. Article 11 of the work specification mentions that a separate "Guidelines for Risk Classification of New Biomedical Technologies" will be formulated. Article 20's risk level directly determines the length of the protection period after approval: 5 years for high risk, 3 years for medium risk, and 1 year for low risk. This difference has a significant impact on company valuation and market strategy.

 

A company's self-assessment is one thing; what experts determine is another. When the classification guidelines will be issued and whether the criteria will be transparent are matters worth close attention.

 

Another unanswered question is the transition for existing projects. There are already a large number of filed stem cell and somatic cell clinical research projects nationwide. Can these projects quickly transition to applications for clinical translational approval? Article 6 of the work specification requires "consistent multi-center independent verification." This is a hard threshold for projects that only have single-center research data. Will multi-center studies need to be supplemented? Will a transition period be established? There is currently no clear answer.

 

The division of responsibilities between the NHC and drug regulatory authorities is also reiterated in Article 3 of the work specification: products that meet the definition of medical devices will follow the medical device registration pathway. However, the red line of "already having a clear product form and being capable of standardization and mass production"—who will make this determination in practice?

 

Article 12 of the work specification states that during the evaluation period, the Biomedical Center may seek opinions from the NMPA. This means that the drug regulator's judgment will play a key role in the approval process. Whether the coordination mechanism between the two authorities is smooth will directly affect companies' pathway choices.

 

With less than two weeks to go before May 1, for companies caught in this wave, the question is no longer "whether to comply," but "how to comply." Some call it a "major reshuffle," while others prefer the term "separating the truth from the falsehood."

 

Regardless, the track defined jointly by the administrative regulation and the work specification has been laid out. The next question is: who will be the first to complete the entire process and obtain the "Approval Notice"?

 

About the CPIC Insights Column

 

The CPIC Insights column, produced by TONACEA, focuses on the core logic behind the rise of Chinese innovative drugs, explores globalization strategies for innovative pharmaceuticals, and is dedicated to building a sustainable innovation ecosystem for China's pharmaceutical industry. The column chronicles the stories of China's rise amid globalization, witnesses key breakthroughs from following to leading, interprets national strategies, tracks cutting-edge technologies, and, through analysis of benchmark events and case studies, highlights the role of China as a major power in the pharmaceutical sector.