9/8/2025CDE Seeks Comments on Draft Technical Guidelines for Chemically Synthe...

9/8/2025CDE Issues Guidance on Evaluating pH-Dependent Drug Interactions for O...

9/8/2025CDE Issues Guidance on Evaluating pH-Dependent Drug Interactions for O...

9/8/2025CDE Issues Technical Guidelines for Clinical Pharmacology Research on ...

9/8/2025NMPA Solicits Comments on Draft Guidelines for Online Prescription Dru...

9/4/2025CDE Seeks Comments on Draft Guidelines for Pan-Cancer Drug Development

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...

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