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City license. The transferee shall have the quality management, risk prevention and control, and liability compensation capabilities to ensure the safety, effectiveness, and quality controllability of...

General Introduction to Gene Therapy Products for Human Use (Draft for Public Notice)OverviewGene therapy products are usually composed of vectors or delivery systems containing engineered gene constr...

Chapter 1 General ProvisionsArticle 1 These Measures are formulated in accordance with the Drug Administration Law of the People's Republic of China and the Regulations on the Administration of Me...

In recent years, immunotherapy has experienced a series of rapid developments. New immunotherapy technologies represented by specific adoptive immune cell therapy and immune checkpoint antibody therap...

Chimeric antigen receptor T cells (CAR-T) refer to the transfer of genetic material with specific antigen recognition domains and T cell activation signals into T cells through gene modification techn...

In recent years, tumor immunotherapy technology has made rapid progress, and gene-modified cell products represented by chimeric antigen receptor modified T cells (CAR-T) have entered the clinic one a...

In order to implement the Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices (Office Letter [2017] No. 42) issued by the General Of...

In recent years, with the continuous development of basic theories, technical means and clinical medical exploration and research such as stem cell therapy, immune cell therapy and gene editing, cell ...

In my country, the cell therapy industry is developing rapidly as a strategic emerging industry, and its growth hotspots cover all aspects from cell banks to cell preparation preparation, cell therapy...

According to the "Decision of the Standing Committee of the National People's Congress on Authorizing the State Council to Carry out Pilot Programs of Drug Marketing Authorization Holder Syst...

In order to promote the reform of the drug review and approval system, encourage drug innovation, improve drug quality, and provide practical experience for further reform and improvement of the drug ...

In recent years, my country's pharmaceutical industry has developed rapidly, and the quality and standards of drugs and medical devices have been continuously improved, which has better met the pu...