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Regulatory News
4/10/2025
China Revises Military Drug Administration Measures to Strengthen Over...
4/8/2025
CDE Solicits Comments on Draft Q&A for CMC Issues in rAAV-Based In Vi...
4/7/2025
China Receives 2.6 Million ADR Reports in 2024, Severe Cases Make Up 1...
4/7/2025
NMPA Mandates Digital QR Code System for Drug Manufacturing Licenses
4/7/2025
NMPA Solicits Comments on the Announcement on Matters Related to the I...
4/5/2025
China and WHO Collaborate on Quality Management Training to Boost Vacc...
3/31/2025
CDE Solicits Comments on the Draft Technical Specification of ICH M11:...
3/26/2025
NMPA Issues Announcement on the Implementation of Chinese Pharmacopoei...
3/26/2025
NMPA Holds 2025 National Drug Regulatory Policy and Law Conference
3/24/2025
CDE Seeks Public Comments on Draft ICH M11 Clinical Protocol Template
3/21/2025
CDE Solicits Comments on Chinese Translation of ICH E6 (R3) GCP Guidel...
3/20/2025
State Council Issues the Opinion on Enhancing TCM Quality and Promotin...
3/20/2025
CDE Publicizes the List of Reference Formulations for GQCE Studies (92...
3/20/2025
NMPA Seeks Public Feedback on Draft Guidelines for Drug Trial Data Pro...
3/19/2025
CDE Issues the 2024 Annual Drug Evaluation Report with Record Surge in...
3/17/2025
NMPA Solicits Comments on Draft Revision of GMP Annex for Sterile Drug...
3/17/2025
China Suspends Imports of Five APIs from Kyowa Hakko Bio's Hofu Plant
3/12/2025
CDE Publicizes the List of Reference Formulations for GQCE Studies (91...
2/28/2025
CDE Seeks Public Feedback on "SPARK Initiative" to Boost Pediatric Onc...
2/21/2025
NMPA Announces Package Insert Revision of Fluorouracil Injection
2/19/2025
China Holds 2025 National Drug Regulation Conference, Setting Key Prio...
2/14/2025
CDE Issues on the Guidelines for Clinical Trial Design of New Drugs fo...
2/12/2025
CDE Issues the List of Reference Formulations for GQCE Studies (90th B...
2/10/2025
CDE Releases Two Guidelines for Acceptance and Review of Chemical and ...
2/10/2025
CDE Issues the Technical Guidelines for the Use of Patient-Reported Ou...
2/10/2025
CDE Issues the Technical Guidelines for Clinical Trials of Gene Therap...
2/10/2025
CDE Issues the Technical Guidelines for Writing Biosimilar Drug Packag...
2/7/2025
NMPA Announces Package Insert Revision of Gemifloxacin Mesylate Tablet...
1/23/2025
CDE Issues the Technical Guidelines for Non-Clinical Research of Proph...
1/23/2025
CDE Issues the Technical Guidelines for Pharmaceutical Studies of Monk...
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