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 ...

7/8/2025NMPA Releases 93rd Batch of Reference Formulations for Generic Drug Ev...

7/8/2025China's NMPA Reopens Public Consultation on Revised Conditional Approv...

7/4/2025CDE Solicits Comments on the 95th Batch of Reference Formulations for ...

7/4/2025CDE Seeks Comment on Revised eCTD Technical Documents and Mapping Tabl...

7/2/2025China to Eliminate CD Submission Requirement for Clinical Trial Databa...

7/2/2025China Issues Technical Guidance for Clinical Resistance Studies of Ant...

7/1/2025CDE Seeks Feedback on Draft Guidelines for Pharma Changes in Cell Ther...

6/30/2025CDE Reopens Public Consultation on Revised Technical Guidelines for Co...

6/20/2025CDE Solicits Comments on the Draft ICH Guideline E21: Inclusion of Pr...

6/20/2025CDE Solicits Comments on the Draft ICH Guideline E21: Inclusion of P...

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