All Regulatory Commercial Useful Website Date Topic Sep 2025 Postapproval Data Capture for Cell and Gene Therapies Aug 2025 China's NMPA Proposes Halving Clinical Trial Review Time to 30 Days to Accelerate Drug Development Jul 2025 European Regulatory Update: Swissmedic Pilots Accelerated Clinical Trial Review And EMA Seeks Feedback On Non-Clinical Development Lessons Jun 2025 US FDA Eliminates REMS For Approved CAR-T Cell Immunotherapies To Enhance Patient Access Jun 2025 China's First Systematic Regulation For Advanced Therapy Medicinal Products (ATMPs): CDE Draft Guidelines Jun 2025 Experts Urge Regulatory Flexibility For Pediatric Cell And Gene Therapies To Accelerate Access And Innovation April 2025 China's New Era Of Regulatory Data Protection: NMPA Draft Measures On Clinical Trial Data Exclusivity Feb 2025 China's Evolving Biopharma Landscape: Innovations And Regulatory Modernization (2019-2023 Review) Jan 2025 Global Cell And Gene Therapy Approvals In 2024: A Year Of Landmark "Firsts" And Therapeutic Expansion Jan 2025 China Approves First Stem Cell Therapy Nov 2024 China Approves MSD's Welireg for VHL Disease Oct 2024 China's Cell Therapy Landscape: Regulatory Framework And Clinical Trial Advancement Insights Jan 2024 Considerations for CAR T-Cell Development Date Topic Sep 2025 Postapproval Data Capture for Cell and Gene Therapies Aug 2025 China's NMPA Proposes Halving Clinical Trial Review Time to 30 Days to Accelerate Drug Development Jul 2025 European Regulatory Update: Swissmedic Pilots Accelerated Clinical Trial Review and EMA Seeks Feedback on Non-Clinical Development Lessons Jun 2025 China's First Systematic Regulation for Advanced Therapy Medicinal Products (ATMPs): CDE Draft Guidelines Jun 2025 US FDA Eliminates REMS for Approved CAR-T Cell Immunotherapies to Enhance Patient Access Jun 2025 Experts Urge Regulatory Flexibility for Pediatric Cell and Gene Therapies to Accelerate Access and Innovation April 2025 China's New Era of Regulatory Data Protection: NMPA Draft Measures on Clinical Trial Data Exclusivity Jan 2024 Considerations for CAR T-Cell Development Date Topic Feb 2025 China's Evolving Biopharma Landscape: Innovations and Regulatory Modernization (2019-2023 Review) Jan 2025 China Approves First Stem Cell Therapy Jan 2025 Global Cell and Gene Therapy Approvals in 2024: A Year of Landmark "Firsts" and Therapeutic Expansion Nov 2024 China Approves MSD's Welireg for VHL Disease Oct 2024 China's Cell Therapy Landscape: Regulatory Framework and Clinical Trial Advancement Insights Website U.S. FOOD & DRUG ADMINISTRATION MedPath
