Last updated: 2025/07/01
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- Opinions of the State Council on the Reform of the Review & Approval System for Drugs and Medical Devices
- The NPC Standing Committee’s Decision on Authorizing the State Council to Carry out the Pilot Drug Marketing Authorization Holder System in Some Places and Related Issues
- Notice of the General Office of the State Council on Issuing the “Pilot Plan on Drug Marketing Authorization Holder System”
- Announcement Notification of “Regulations on the Quality Management of Cell Bank Establishment”
- The Comprehensive Affairs Department of NMPA Issued the Announcement on “Technical Guideline for the Pharmaceutical Study and Evaluation of Cellular Therapy Products” (No. 216, 2017)
- The Comprehensive Affairs Department of NMPA Issued the “Announcement on the Direct Reporting of Adverse Reactions by Marketing Authorization Holders (Draft for Comments)”
- Considerations on “IND Application Studies and Application Materials for Cellular Therapy Products”
- Notification of “CAR-T Cell Quality Control Testing Research and Non-clinical Study Considerations”
- Announcement of “Regulations on Manufacturing Quality Management for Chimeric Antigen Receptor T Cell (CAR-T cell)-based Drug Products”
- The General Office of the National Health Commission issued the Letter of Opinion on “Administrative Measures for the Clinical Research and Translational Use of Somatic Cell Therapy (Interim)
- Proclamation of the “General Instructions on Human Gene Therapy Products (Draft)”
- Full text of the new “Drug Administration Law of the People's Republic of China”
- NMPA (formerly CFDA) Solicits Public Comments on “Good Manufacturing Practice (GMP) – Appendix for Cellular Therapy Drugs” (Draft for Comments)
- The Comprehensive Affairs Department of NMPA Solicits Public Comments on “Inspection Procedures of Drug Product MAHs (Draft for Comments)”
- The Comprehensive Affairs Department of NMPA Solicits Public Comments on “Key Points for Inspection of Drug Product MAHs (Draft for Comments)”
- The Comprehensive Affairs Department of NMPA Solicits Public Comments on “Guidelines for Quality Agreement on Drug Consignment Production (Draft for Comments)”
- The Comprehensive Affairs Department of NMPA Solicits Public Comments on “Reference Template for Quality Agreement on Drug Consignment Production (Draft for Comments)”
- Newly Revised “Provisions for Supervision and Administration of Drug Manufacturing”
- Newly Revised “Provisions for Drug Registration”
- Notification of Public Comment Soliciting on “Technical Guideline for the Pharmaceutical Study and Evaluation of Cell-based Immunotherapy Products (Draft for Comments)”
- Notification of Public Comment Soliciting on “Technical Guideline for the Pharmaceutical Study and Evaluation of Gene Therapy Products (Draft for Comments)”
- [IIT] Announcement on Public Comment Soliciting on the “Administrative Measures for Investigator Initiated Clinical Trials by Medical and Health Institutions (Draft for Comments)”
- Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Clinical Trial of Cell-based Immunotherapy Products (Interim)” (No. 14, 2021)
- NMPA issued the “Measures for the Administration of Drug Inspection (Interim)”, and abolished the original drug administrative measures for GMP and GSP certification!
- European Medicines Agency updates Reflection Paper on GMP Responsibilities of MAHs
- The Comprehensive Affairs Department of NMPA Solicits Public Comments on “Good Manufacturing Practice (GMP) – Appendix for Cellular Therapy Drugs (Draft for Comments)”
- Cell Therapy CDMO — New Track in Pharmaceutical CXO Industry, the Untapped Area
- The Comprehensive Affairs Department of NMPA Solicits Public Comments on “Good Manufacturing Practice (GMP) – Appendix for Investigational Drugs (Draft for Comments)”
- Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Clinical Risk Management Plan for Marketing Application of Chimeric Antigen Receptor T cell (CAR-T) Therapy Pro
- Who will become the leading “water supplier” during the “gold rush” of the cellular therapy industry?
- The Comprehensive Affairs Department of NMPA Solicits Public Comments on “Key Points for Inspection of Drug Product MAHs (Draft for Comments)”
- Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Evaluation of Immune-related Adverse Events in Antitumor Therapy” (No. 25, 2022)
- Hillgene Winning the Bid on the First Contract Manufacturing Order for Commercial CAR-T Cell Therapy in China
- [GMP revised] Appendix for “Investigational Drugs (Interim)” issued and taking effect as of July 1!
- Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Pharmaceutical Study and Evaluation of Ex-vivo Genetic Modification System (Interim)” (No. 29, 2022)
- Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Pharmaceutical Study and Evaluation of Cell-based Immunotherapy Products (Interim)” (No. 30, 2022)
- Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Pharmaceutical Study and Evaluation of In-vivo Gene Therapy Products (Interim)” (No. 31, 2022)
- CDE issued “Guidelines on Clinical Trial Statistics of Drug Products for Rare Diseases (Interim)”
- Important Report from CDE! The Annual Report on Progress of Clinical Trials for New Drug Registration in China (2021)
- CDE: Notification of Public Comment Soliciting on “Technical Guideline for the Clinical Research and Development of New Drug Products for Chronic Lymphocytic Leukemia (Draft for Comments)”
- Big News: FDA issued the finalized version of guidance “Comparability Protocols for Post-approval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA”
- Big News: Newly released “Good Manufacturing Practice for Cellular Therapy Products (Interim)”!
- MAH issued“Provisions for Supervision and Administration of Drug Quality (Interim)”
- NMPA issued the Announcement on “Implementing Electronic Application of Drug Registration”
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