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.

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.

As soon as the news came out, the industry's response was destined to be divided.

For top enterprises and large tertiary hospitals, this is no different from the final step of policy dividends moving from paper to reality. The regulations clearly stipulate that institutions conducting clinical research on new biomedical technologies such as cell therapy must be tertiary Grade A medical institutions, and must have academic and ethical committees that meet the requirements.

In other words, the position of tertiary hospitals in the entire industry chain has been systematically elevated. As of December 2025, 33 tertiary hospitals in China have established centers for cell therapy and regenerative medicine, and have entered the field.

Huangpu District of Guangzhou Development Zone is already taking action. On April 10th, the district established the first 818 public service platform in the province and even in southern China, led by district and county health administrative departments - the Guangzhou Development Zone Biomedical New Technology Clinical Research and Translational Application One stop Service Center.

For Huangpu, the implementation of the regulations has expanded the coverage of some businesses that were previously only available in the free trade zone to the whole country. The zone has over 4800 biopharmaceutical companies, 21 listed companies, 154 CGT related companies, and 18 research-oriented hospital alliances in the city, and is transitioning from a "large-scale area" to a "high-quality area".

The Pudong New Area in Shanghai is also accelerating. Recently, the Zhangjiang Pharmaceutical Valley International Innovation Conference and the 2026 Shanghai Stem Cell Industry Conference were held in Pudong. Pudong has produced the first gene therapy product in China, with four CAR-T products on the market, accounting for half of the country's total. On the eve of the conference, the third domestic stem cell "Drug Production License" was granted to Zhangjiang Pharmaceutical Valley.

These signals collectively point to a trend: the implementation of policies is accelerating the concentration of resources towards top regions and enterprises. But for small and medium-sized enterprises that have been wandering in gray areas for years, the situation is not so optimistic.

The new regulations explicitly prohibit the collection of fees from subjects in any form during the clinical research stage, and for the first time, list medical institutions and medical personnel as the direct responsible parties. The punishment for violations is extremely severe: conducting research without registration will result in a fine of 200000 to 1 million yuan for the institutions involved; The main person in charge shall not engage in relevant clinical research activities within 5 years.

Industry observers bluntly state that the triple threshold of cooperating with top tier hospitals that can pass technical registration, investing sufficient clinical expenses, and providing free treatment to participants is enough to keep 80% of cell companies out.

The development path of the dual track system has also been thoroughly clarified in this process. The revised Implementation Regulations of the Drug Administration Law (Order 828) in January 2026 further clarify the path of drugization for cell therapy.

Two administrative regulations jointly establish a clear compliance development path: either take the route of drug registration and listing, and invest heavily to meet CMC and clinical requirements; Either take the route of medical technology transformation, deeply bind with tertiary hospitals, and become their technology service providers.

The release of work standards has answered many questions, but it has also left some unanswered questions. The biggest suspense is the specific criteria for risk classification.

Article 11 of the work standards mentions that the "Guidelines for Risk Grading of Biomedical New Technologies" will be formulated separately, and the risk level in Article 20 directly determines the length of the protection period after approval. The difference between high-risk for 5 years, medium risk for 3 years, and low-risk for 1 year has a significant impact on corporate valuation and market strategy.

Enterprise self-evaluation is one thing, expert evaluation is another. When the grading guidelines will be issued and whether the standards are transparent are worth continuous attention.

Another suspense is the connection of existing projects.

There are already a large number of registered stem cell and somatic cell clinical research projects nationwide. Can these projects be quickly converted into clinical application applications? Article 6 of the work standards requires "multi center independent verification consistency", which is a hard threshold for projects with only single center research data. Is it necessary to conduct a multicenter study? Will a transition period be set up? There is currently no clear statement.

The division of labor boundary between the National Health Commission and the drug regulatory department is once again emphasized in Article 3 of the work standards: those that meet the definition of medical devices shall go through medical device registration. But who will judge the red line of 'already having a clear product form and being able to carry out standardized and large-scale production' in actual operation?

Article 12 of the work standards states that during the evaluation period, the Biological Center may seek opinions from the drug regulatory department of the State Council. This means that the judgment of the drug regulatory department will play a crucial role in the approval process. The smooth collaboration mechanism between the two departments will directly affect the path selection of the enterprise.

It has been less than two weeks since May 1st. For companies caught in this wave, now is not the time to discuss whether to comply, but rather the question of how to comply. Some people refer to it as the 'Great Shuffle', while others prefer to call it 'removing falsehood and preserving truth'.

Anyway, this track, jointly defined by administrative regulations and work standards, has already been laid out. The next question is: Who can be the first to complete the entire process and obtain that Approval Notice?