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Regulatory News
3/11/2026
China Releases Trial Guideline for Influenza Vaccine Clinical Studies
3/11/2026
China Issues Revised Technical Guideline for HPV Vaccine Clinical Tria...
3/11/2026
China Seeks Comments on Draft Technical Guideline for Rare Disease ERT...
3/9/2026
China Publishes 102nd Batch of Reference Formulations for Generics and...
3/9/2026
NMPA Seeks Input on Draft Guidelines for Quality Summaries of Therapeu...
3/5/2026
CDE Issues Guidance on Subject Selection for Oncology Drug Bioequivale...
3/4/2026
CDE Invites Feedback on Draft Technical Guideline for Preventive mRNA ...
3/4/2026
CDE Issues Technical Guideline on Clinical Trials for Drugs Treating C...
3/2/2026
CDE Issues Interim Guidelines for Synthetic Oligonucleotide Innovativ...
2/25/2026
CDE Solicits Comments on Batch 104 of Chemical Generic Reference Formu...
2/24/2026
China Prepares to Implement Landmark Regulations for Clinical Research...
2/24/2026
CDE Issues Guidelines on Benefit-Risk Assessment Using Multi-Regional ...
2/24/2026
CDE Releases Q&A Document on Development Safety Update Reports
2/24/2026
CDE Issues Guideline on Clinical Information for CAR-T Therapy Package...
2/12/2026
CDE Issues Draft Pharmaceutical Guidance for Rare Disease Chemical Dru...
2/9/2026
CDE Issues Technical Guideline for Generic Sodium Iodide [131I] Oral S...
2/5/2026
2026 National Conference on Drug Registration and Post-Market Regulati...
2/5/2026
CDE Issues Trial Guideline for Neuropathic Pain Drug Development
2/5/2026
CDE Issues Technical Guideline for Clinical Trials of Chronic Insomnia...
2/3/2026
NMPA Logs Wave of Novel Drug Approvals and Clinical Trial Clearances L...
2/3/2026
China and USFDA Officials Pledge to Deepen Regulatory Cooperation at B...
1/30/2026
China Solicits Comments on 103rd Batch of Reference Formulations for C...
1/30/2026
China Releases New Guideline on CMC Changes for Cell Therapy Products
1/30/2026
CDE Issues New Clinical Trial Guideline for Antifibrotic Drugs in Inte...
1/30/2026
CDE Issues Trial Guideline to Standardize Clinical Development of Anti...
1/28/2026
CDE Issues New Technical Guidance for Clinical Trials of Long-Acting L...
1/28/2026
NMPA Releases 101st Batch of Reference Formulations for Generic Drug E...
1/27/2026
China Issues Revised Implementing Regulations for the Drug Administrat...
1/27/2026
NMPA Adopts ICH M14 Guideline on Real-World Evidence for Drug Safety E...
1/26/2026
CDE Issues Technical Guidance on NMR Studies for Glycoconjugate Vaccin...
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