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...
From November 13 to 14, 2021, the 2021 Third Annual Bioprocess Industry Summit was successfully held in Shanghai. With the theme of "Latecomers Arrive Faster, Great Things Will Come", many e...
On October 11-12, 2021, the BPID Biopharmaceutical Industry Development Conference and the 2021 Life and Health Industry Summit Forum were successfully concluded in Shanghai. The conference discussed ...
From October 13 to 16, 2021, the "First China (Suzhou) Taihu Pharmaceutical Innovation Conference" hosted by the Wuzhong District People's Government of Suzhou City and undertaken by the...
On August 14, 2021, Jiangsu Spectrum Biopharmaceutical Co., Ltd. (hereinafter referred to as "Spectrum Bio") and Promis Biotech Co., Ltd. (hereinafter referred to as "Promis") reac...
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...
Cell and gene therapy technology is undoubtedly one of the most popular biotechnology fields at present, and is also regarded as the next generation of innovative therapies for disease treatment. In t...
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...
86 198 5711 6962 
info@hillgene.com 
English
