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