Tumor immunotherapy is a hot topic in the current research and development of new anti-tumor drugs. How to improve the scientificity and robustness of the identification and judgment of immune-related...
In order to strengthen the supervision and management of drug marketing authorization holders (hereinafter referred to as holders), supervise the holders to fulfill the quality management responsibili...
2022 marks the 10th anniversary of Emily Whitehead, the world's first child with leukemia cured by CAR-T cell immunotherapy, achieving cancer-free survival.In 2012, Emily, who suffered from acute ...
Chimeric antigen receptor CAR-T cells (CAR-T) refer to a type of T cell that can recognize a specific antigen by introducing vectors such as viruses into autologous or allogeneic T cells through gene ...
Chapter I ScopeArticle 1 This Appendix applies to the preparation of drugs for clinical trials (including test drugs and placebos). This Appendix also applies to changes in packaging and labeling of m...
The era of cell therapy has arrived, bringing hope to complex and intractable diseases, and CDMO has helped it develop rapidlyIn 2021, Fosun Kite's Akilencel injection and WuXi Junuo's Rekioll...
Chapter 1 ScopeArticle 1 [Scope] The cell therapy products (hereinafter referred to as cell products) described in this appendix refer to living cell products of human origin, including cells that hav...
On July 27, the European Medicines Agency (EMA) released a reflection paper on GMP and MAH, "Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders", which stipu...
Chapter I General ProvisionsArticle 1 These Measures are formulated in accordance with the Drug Administration Law of the People's Republic of China, the Vaccine Administration Law of the People&#...
In 2017, the former State Food and Drug Administration issued the "Technical Guidelines for Research and Evaluation of Cell Therapy Products (Trial)", which generally elaborated on the techn...
Measures for the Administration of Clinical Research Initiated by Medical and Health Institutions(Draft for Comments)Chapter I General ProvisionsArticle 1 (Purpose) In order to standardize the managem...
Technical Guidelines for Pharmaceutical Research and Evaluation of Gene Therapy Products(Draft for Comments)ForewordIn recent years, with the continuous advancement of gene delivery systems and editin...
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