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Regulatory News
8/29/2025
CDE Issues Draft Requirements for Module 2 Chemistry Doc...
8/29/2025
CDE Issues Technical Guideline for Non-Clinical Research of Vaccine Ad...
8/29/2025
CDE Invites Public Comment on 97th Batch of Reference Formulations for...
8/29/2025
CDE Solicits Comments on Draft Guideline for Post-Approval Change Mana...
8/29/2025
CDE Seeks Comment on ICH E6(R3) GCP Implementation Recommendations
8/21/2025
NMPA Lifts Import Suspension on Vasudha's Loratadine API
8/21/2025
China Proposes Conflict-of-Interest Declarations for Drug Clinical Tri...
8/21/2025
China Drafts Guidance on Single-Arm Trials to Support Oncology Drug Ap...
8/14/2025
CDE Seeks Public Input on Draft Guidelines for Bayesian Methods in Cli...
8/14/2025
CDE Issues New Technical Guidelines for Clinical Development of Osteoa...
8/14/2025
CDE Solicits Comments on Draft ICH M4Q(R2) Guidelines for Drug Qualit...
8/14/2025
CDE Seeks Public Input on Draft Guidelines for Rare Disease Drug Devel...
8/6/2025
CDE Releases Updated Roster of External Drug Review Experts
8/6/2025
CDE Solicits Comments on Guidelines for Developing Appropriate Drug Pa...
8/6/2025
CDE Seeks Public Comments on Revised Technical Guidelines for Recombin...
8/5/2025
China Seeks Public Feedback on New Internet Drug and Device Informatio...
7/31/2025
China Seeks Feedback on Draft Guidelines for Eosinophilic Esophagitis ...
7/30/2025
CDE Issues Technical Guidelines on Drug Exposure–Response Relationshi...
7/30/2025
CDE Releases New Guidelines on Impurity Limits for Fermentation or Sem...
7/30/2025
CDE Issues New Guidance on Clinical Pharmacology Research for Rare Dis...
7/30/2025
CDE Issues Technical Guidance on Model-Informed Drug Development for R...
7/28/2025
China Issues 2025 Edition of Controlled Drug Lists for Medical Narcoti...
7/26/2025
Ambroxol Hydrochloride Drops Reclassified as OTC Drug in China
7/22/2025
CDE Solicits Comments on Proposed Labeling Update for Pediatric Use of...
7/22/2025
CDE Issues Q&A Guidance on Pharmaceutical Similarity Studies for Biosi...
7/18/2025
China Seeks Comments on 96th Batch of Reference Formulations for Gener...
7/18/2025
China Unveils New Clinical Trial Guidelines for Antibacterial Drugs Ta...
7/18/2025
China Issues New Draft Guidelines for Pharmaceutical Development of Or...
7/16/2025
China Unveils New Atopic Dermatitis Guidelines and JAK1 Advances at Gl...
7/16/2025
FDA Loosens Global Trial Standards but Keeps a Cautious Distance from ...
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