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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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INDUSTRY
[Updated] Top 10 CROs With the Highest Revenues in 2023
In 2023, most contract research organizations (CROs) on the top 10 list of the highest revenues experienced modest growth rates of less than 5%. Two CROs—Syneos and Catalent even saw a decline in their revenues. Only Lonza and Samsung Biologics achieved year-on-year growth of over 10%.
Apr 30, 2024
PIPELINE
[Updated] Pharma Licensing Deals Involving Chinese Companies in 2023
In 2023, the Chinese pharma industry witnessed a total of 124 licensing deals, with a combined transaction value of USD 50.59 billion. Compared to the previous year, the transaction value of licensing deals in 2023 increased by 41% year on year, while the number of deals decreased by 38%.
Apr 29, 2024
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 | March 2024
Check out the latest pharma regulatory updates in China: 1. NMPA Rolls Out the 78th RLD List; 2. NMPA Grants Six Rx-to-OTC Switches; 3. NMPA Implements Electronic Submission for Import and Export License Applications of Anesthetics and Psychotropics; 4. NMPA Issues Regulation on Exploratory Research on Drug Sampling and Testing...
Apr 12, 2024
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
