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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 | February 2024
Check out the pharma regulatory updates in February 2024: 1. NMPA Issues the 2023 Drug Evaluation Report 2. NMPA Rolls out the 76th and 77th lists of RLDs 3. NMPA Specifies Administrative Penalties for Drug-related Illegalities 4. China Releases Pharmaceutical Guidelines 5. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards
Mar 13, 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
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
REGULATION
China to Enforce Revised Rules on Drug Patent Term Compensation
The revised Rules on the Implementation of the Patent Law of the People’s Republic of China is set to come into effect on January 20, 2024. The revised Rules includes provisions specifically related to drug patents which are significant for new drug applicants.
Jan 19, 2024
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | December 2023
Check out the pharma regulatory updates in Dec 2023: 1. China Encourages the Development of 39 Generic Drugs; China CDE Updates eCTD Structure for Drug Registration Applications; 3. China Releases the 74th List of Reference Drugs...
Jan 04, 2024
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
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GSP
Monthly Recap: China Pharmaceutical Regulatory Updates | October 2023
China pharma regulatory updates for Oct 2023: 1. NMPA Enforces Regulation on API Registration Renewal; 2. NMPA Tightens Regulation on Outsourced Manufacturing for MAHs; 3. NMPA and NHC Announce Chinese Pharmacopoeia 2020 Edition’s 1st Addendum; 4. NMPA Requires ANDAs Without RLDs to Demonstrate Clinical Value...
Nov 08, 2023
REGULATION
China Tightens Regulation on Outsourced Manufacturing for Drug Marketing Authorization Holders (MAHs)
On Oct. 23, 2023, China's NMPA issued the Notice on Enhancing the Supervision and Management of Outsourced Manufacturing for Drug Marketing Authorization Holders (MAHs), which took immediate effect.
Oct 26, 2023
REGULATION