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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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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
Law & Regulation
Guideline
Marketing Approval
Priority Review
NRDL
Health Insurance
Rare Disease
Drug Registration
Real World Data
The 16th Rare Disease Day: China's Efforts to Make Orphan Drugs Available and Affordable
This year’s Feb. 28 marks the 16th International Rare Disease Day. In China, there are around 20 million rare disease patients, with more than 200,000 additional patients each year. China has shown a supportive attitude towards rare disease drug development in a series of official documents. The regulations and policies introduced in this article are significant in terms of the drugs’ marketing authorization review timeline and pricing.
Mar 10, 2023
REGULATION
Law & Regulation
MAH
Pharmacovigilance
Marketing Approval
Priority Review
Health Insurance
Innovative Drug
Generic Drug
Rare Disease
Drug Registration
New Drug
China Encourages Innovative Drug R&D in Revised Draft of Regulations for Implementing the Drug Administration Law
Find out the highlights in revised draft of the Regulations for Implementation of the Drug Administration Law: pharmaceutical innovation, acceptance of foreign clinical data, support the development of pediatric and rare disease drugs...
May 13, 2022
REGULATION
Law & Regulation
Marketing Approval
Clinical Trial
Priority Review
Innovative Drug
API
Rare Disease
New Drug
The 15th Rare Disease Day: China's Policy & Market Overview
China tries to make rare disease drugs available to more patients via measures like expediting the marketing approval of the drugs and reimbursing part of the medical expenses. Meanwhile, the rare disease treatment market is expanding rapidly.
Mar 04, 2022
REGULATION
REGULATION
Law & Regulation
Reference Listed Drug (RLD)
Marketing Approval
Priority Review
Innovative Drug
Generic Drug
Drug Registration
New Drug
How Will China Regulate and Boost Pharmaceutical Industry by 2025
At the end of 2021, China announced its National Plan for Promoting Drug Safety and the High-quality Development of the Pharmaceutical Industry during the 14th Five-Year Plan (2021-2025). To realize the 2035 vision which includes an internationally-advanced drug regulatory system, China sets tasks to be completed by 2025.
Jan 14, 2022
REGULATION
Law & Regulation
Pharmacopoeia
MAH
Pharmacovigilance
Marketing Approval
Priority Review
Volume-based Procurement
Top 10 BaiPharm Stories of China's Pharmaceutical Regulations | 2021 Recep
ChemLinked BaiPharm Portal has been delivering and decoding China's pharmaceutical regulations to help international drug makers access the Chinese market. Here are the 10 regulatory topics that our readers are most concerned about in 2021.
Jan 07, 2022
REGULATION
China CDE to Disclose New Drugs' Technical Review Reports
China's Center of Drug Evaluation (CDE) recently announced that it would disclose the technical review reports and package inserts of all new drugs approved since Sept. 1, 2016. The disclosure would also extend to generic drugs and other applications in the future.
Mar 08, 2021
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- [Updated] China Expedites Process for Transferring Overseas Drug Manufacturing Sites to China
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- Monthly Recap: China Pharmaceutical Regulatory Updates | March 2024