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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | January 2024
A recap of China's pharma regulatory updates in Jan 2024: CDE Conditionally Waives Registration Documents for Overseas Manufactured Drugs, NMPA Outlines Key Considerations for Inspecting Third-party Platforms for Online Drug Sales...
Feb 06, 2024
REGULATION
China to Streamline Process for Transferring Overseas Drug Manufacturing Sites to China
The draft brings encouraging news as it suggests that China may accept the original registration application dossier of overseas drugs, including documents related to chemistry, manufacturing, and controls, non-clinical and clinical studies, if they remain applicable.
Jan 25, 2024
INDUSTRY
REGULATION
China CDE Updates eCTD Structure for Drug Registration Applications
On Dec 11, 2023, China CDE announced updates regarding the electronic submission of drug registration applications. These updates are compiled into the Technical Requirements for Compact Disks Containing Application Dossiers and Electronic Common Technical Document (eCTD) Structure. In addition, CDE has also introduced the eCTD Validation Criteria as a regulatory document. These three documents will come into effect on March 1, 2024.
Dec 18, 2023
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | November 2023
Check out the latest pharma regulatory updates in China: 1. China NMPA Applies for PIC/S Membership; 2. China to Adopt System for E2B (R3) Electronic Transmission of ICSRs; 3. China NMPA Grants Three Rx-to-OTC Switches; 4. China Includes 195 Drug Products in Its 9th National VBP; 5. China NMPA Issues Inspection Regulation on Clinical Trial Institutions; 6. China NMPA Consults on Anesthetics and Psychotropics Regulations; 7. China CDE Releases Pharmaceutical Guidelines; 8. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards
Nov 30, 2023
Most Popular
- Monthly Report: New Drug Approvals in China | January 2024
- Monthly Recap: China Pharmaceutical Regulatory Updates | January 2024
- China to Streamline Process for Transferring Overseas Drug Manufacturing Sites to China
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- Monthly Recap: China Pharmaceutical Regulatory Updates | February 2024