The 12th session of the Standing Committee of the 13th National People's Congress voted on the 26th to adopt the revised Drug Administration Law, which will come into effect on December 1, 2019.

This marks the second comprehensive and structural overhaul of the Drug Administration Law since its enactment in 1984. By elevating the reform achievements and proven practices in the pharmaceutical sector into law, we will provide stronger legal safeguards for public health.

So, what impact does this have on stem cell drug development companies?

Encouraging innovation is a major highlight of the new law.

At a special press conference held by the General Office of the Standing Committee of the National People's Congress after the meeting, Liu Pei, Director-General of the Department of Policies and Regulations at the National Medical Products Administration, stated that the General Provisions of the Drug Administration Law clearly stipulate the state's commitment to encouraging research and development of innovative new drugs. Additionally, the law has introduced and refined several institutional measures aimed at fostering innovation and accelerating the availability of new medicines on the market.

Data shows that applications for innovative drugs increased by 75% in 2018 compared to 2016. Among the 48 new drugs approved in 2018, 18 were cancer treatments—representing a 157% increase from 2017.

The systems primarily encouraging new drug development under the Drug Administration Law include:

I. Clearly defined the directions for encouragement, We will prioritize supporting drug innovation that is clinically driven and demonstrates clear efficacy against human diseases. Additionally, we encourage developments based on novel therapeutic mechanisms, particularly for treating severe, life-threatening conditions. • Development of new drugs for rare diseases and pediatric medications.

2. Innovate the review and approval mechanism, strengthen capacity-building within review agencies, enhance communication and dialogue with applicants, establish an expert advisory system, streamline the review process, and boost review efficiency—providing robust organizational support for drug innovation.

III. Clinical trial management has been optimized: previously, clinical trial approvals were granted through an approval-based system, but now they operate under an implicit approval system. Additionally, the accreditation process for clinical trial institutions has shifted to a filing-based management approach, significantly enhancing the efficiency of clinical trial approvals.

4. Establish integrated review and approval processes: When reviewing and approving pharmaceutical products, adjust the evaluation and approval procedures for chemical APIs, related excipients, and packaging materials/containers that directly contact the drug—integrating them with the formulation review and approval. At the same time, concurrently approve the drug’s quality standards, manufacturing processes, labels, and package inserts.

V. Priority review and approval processes have been implemented, establishing a "green channel" for urgently needed, scarce drugs, as well as new medicines targeting major infectious diseases, rare illnesses, and pediatric treatments—ensuring these are given top-priority review and approval.

6. Established Conditional Approval System It's just For diseases that are life-threatening and currently lack effective treatments, as well as for urgently needed public health medicines, clinical trials have already demonstrated efficacy—and where clinical value can be reliably predicted—conditional approval may be granted. This approach accelerates the availability of critically needed drugs by reducing the time required for clinical development, ensuring that patients in urgent need of treatment can access new therapies as quickly as possible. 。

The U.S. FDA has already granted orphan drug status or fast-track approval to several stem-cell therapies currently in development. Meanwhile, both Japan and South Korea have adopted streamlined regulatory approaches for stem-cell products, including conditional approvals and specialized review pathways. Notably, Japan has previously conditionally approved the use of mesenchymal stem cell technology to treat patients with spinal cord injuries, while South Korea already has several stem-cell drugs on the market.

Conditional approval comes with stricter requirements, such as explicitly stating relevant details in the drug registration certificate. After a drug is approved for market release, the marketing authorization holder must also implement even more rigorous risk-management measures and complete the mandated studies within the specified timeframe. If these studies are not completed, or if the holder cannot demonstrate that the benefits outweigh the risks, the National Medical Products Administration reserves the right to take legal action—potentially including the outright revocation of the drug’s registration certificate. This regulation ensures both the fulfillment of clinical needs and the ongoing safety of drugs available on the market.

According to incomplete statistics, there are already 14 stem-cell drugs available on the global market, but currently, no stem-cell drugs have been approved for sale in China.

On August 18, during the 47th session of the "Understanding the Future" science lecture series, Li Wei, a researcher at the Institute of Zoology, Chinese Academy of Sciences, and Deputy Director of the National Key Laboratory of Stem Cell and Reproductive Biology, stated: "We expect that within a relatively near timeframe—perhaps in the next 5 to 10 years—officially approved stem-cell-based drug products will become available for sale after receiving approval from the National Medical Products Administration." With the support of new government policies encouraging innovation, the pace of bringing stem-cell therapies to market is steadily accelerating!

This is the best of times! The national and local governments have been rolling out numerous supportive policies to boost the biopharmaceutical industry, particularly advancing cutting-edge cell therapy technologies like immune cell therapy and stem cell treatment. Jiuzhitang Maker will also align with this era of growth, continuing to focus on stem cell research and the commercial-scale production of stem cells—bringing tangible benefits to people everywhere!

References:

"Draft Amendment to the People's Republic of China Drug Administration Law"

Transcript of the Press Conference Held by the General Office of the Standing Committee of the National People's Congress (Excerpts on Questions and Answers Related to the Drug Administration Law)