Know Yourself: Regulatory Interpretation and Pre-market Compliance Strategies for Cell Therapy in China and the United States

The United States is the world's largest cell therapy research and development country, with 374 gene and cell therapy (CGT) clinical trials registered in the INFORMA drug database, and the United States leads with 120 clinical trials [1].

In the field of stem cell therapy research, there is a pattern of "one super and many strong" in
the world.
Compared with the United States, China's cell therapy research started not too early, but the development speed is relatively fast
.
According to a statistic from Nature, the number of cell therapy R&D pipelines in China reached 695 in 2021, leading the global cell therapy R&D pipeline together with the United States [2].

。 In the field of cell therapy regulation, the United States has formed a mature and complete institutional system; In China, the regulatory authorities have successively introduced policies and systems related to cell therapy, and gradually built a regulatory system
in the field of cell therapy unique to China.
What is the current research and development progress of cell drugs in China and the United States? What are the representative products and companies? This article summarizes the core points of cell therapy regulations in China and the United States, summarizes and analyzes the key points of operation and listing compliance of related enterprises, and provides corresponding compliance suggestions, aiming to help cell therapy companies achieve long-term operation
.
Let's sort them out
for you one by one.
 

-01-

At present, cell therapy is divided into two types
: immune cell therapy and stem cell therapy.
Among them, immune cell therapy is mainly divided into the following categories:

-02-

After combing, China's cell therapy regulation is divided into two paths, medical technology and drugs, which have roughly gone through three stages, respectively, from 1993 to 2015, and the supervision is relatively relaxed; In 2016, the strict adjustment stage; The comprehensive specification stage from 2017 to the present is as follows:

(1) The period from 1993 to 2015 was relatively relaxed

Before 2016, China has recognized the broad prospects of cell therapy, various policies to emphasize the importance of cell therapy, the overall relaxation of supervision, cell therapy companies in a state of free development, a large number of clinical research projects, there are also a lot of cell therapy chaos, especially the "Wei Zexi" incident in April 2016, reflecting that there were regulatory loopholes in cell therapy in China at that time, and subsequently, the state adjusted the corresponding regulatory scale
.

(3) After 2017, the stage of comprehensive standardization

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