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Regulatory News
12/9/2024
CDE Publicizes the List of Reference Formulations for GQCE Studies (89...
12/6/2024
CDE Seeks Comments on Draft ICH Guidelines M15
12/4/2024
CDE Issues the List of Reference Formulations for GQCE Studies (85th B...
11/28/2024
NMPA Solicits Public Comments on the Provisions for the Record Filing ...
11/27/2024
ChP Commission Approves Chinese Pharmacopeia 2025
11/19/2024
NMPA Annouces Adoption of ICH Guideline E11A for Pediatric Extrapolati...
11/18/2024
CDE Issues the Technical Guidelines for Clinical Pharmacology Research...
11/18/2024
CDE Issues the Guidelines for Application of Disease Registry-Based Re...
11/15/2024
NMPA Issues the Interim Rules on Designated Domestic Representatives f...
11/14/2024
CDE Seeks Public Comments on the Supplemental List of External Exper...
11/14/2024
NHC Holds Forum with Domestic and Foreign Pharma Cos on Compliance Iss...
11/7/2024
CDE Issues the Notice on the Technical Requirements for Pilot Registra...
11/5/2024
NMPA Solicits Public Comments on Drug Contract Manufacturing Document
11/4/2024
Li Li Meets with Head of Brazil's Health Regulatory Agency
11/4/2024
NMPA Signs Letter of Intent on Cooperation with Danish Medicines Agenc...
11/1/2024
NMPA Issues Announcement for Applicability of ICH Guideline M12
10/31/2024
CDE Issues the List of Reference Formulations for GQCE Studies (84th B...
10/30/2024
China Set to Achieve Full Drug and Medical Consumables Traceability by...
10/29/2024
CDE Issues the Common Issues and Technical Requirements for Replicatio...
10/28/2024
China Expands Contract Manufacturing for Biopharmaceuticals in New Pil...
10/25/2024
CDE Solicits Comments on the Technical Guidelines for Clinical Pharmac...
10/25/2024
CDE Solicits Comments on the Technical Guidelines for Clinical Researc...
10/25/2024
China and Denmark Strengthen Collaboration in Pharmaceutical and Medic...
10/24/2024
CDE Issues the Dossier Requirements for Marketing Registration Applica...
10/24/2024
CDE Solicits Comments on the Technical Guidelines for Evaluating pH-De...
10/24/2024
CDE Issues the Notice on Prioritized Acceptance Service for Innovative...
10/22/2024
CDE Issues the Technical Requirements for the Pharmaceutical Research ...
10/21/2024
NMPA Issues the Pilot Plan for Staged Production of Biological Product...
10/21/2024
CDE Solicits Comments on the Scope and Procedures for Filing Bioequiva...
10/18/2024
CDE Publicizes the List of Reference Formulations for GQCE Studies (87...
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