News
Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
Hot topic
REGULATION
[Updated] China Expedites 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.
Apr 24, 2024
REGULATION
China Consults on Self-Evaluation Report Guidance for Generic Drug Registration
On April 2, 2024, China’s Center for Drug Evaluation (CDE) released the two drafts of Chemical, Manufacturing, and Controls (CMC) Self-evaluation Reports on Class 3 Chemical Drug Registration Applications, one for drug substances, and the other for drug products.
Apr 15, 2024
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
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