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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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POLICY
China Waives Import Tariffs for Active Ingredients of Anti-cancer and Rare Disease Drugs in 2024
China will waive import tariffs for 62 active pharmaceutical ingredients (API) of anti-cancer drugs and 5 APIs of rare disease drugs, starting from Jan 1, 2024. Medical products such as nirmatrelvir for COVID-19, insulins for diabetes, vaccines, gene therapies, and more will also enjoy interim zero tariffs.
Jan 01, 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
REGULATION
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CMC
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Excipient
Monthly Recap: China Pharmaceutical Regulatory Updates | November 2022
Check out China's Pharma Regulatory Updates for November 2022: 1. China NMPA Renews Classifications of Sodium Hyaluronate Products;
2. China NMPA Requires All Drug Registration Application Documents to Be Submitted in Compact Disks; 3. China NMPA Consults on Chemical API Registration Renewal Regulation, and more.
Dec 09, 2022
INDUSTRY
China's Pharmaceutical Industry Expected to Be the World's Largest in Less Than 10 Years
As of 2021, China holds 12% of the global pharmaceutical market, following the United States, responsible for 40% of the total revenue worldwide. Chinese pharma market is reported to have generated 708.75 billion yuan in 2021, while Chinese domestic pharma companies amassed 502 billion USD (3.37 trillion RMB) in revenue.
Jul 28, 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
China Cracks Down on Monopolies in Active Pharmaceutical Ingredient Industry
On Nov. 18, China issued the Anti-Monopoly Guidance for Active Pharmaceutical Ingredients, clarifying regulations against monopoly agreements, abuse of market power, and concentration of undertakings in the API industry.
Nov 26, 2021
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | March 2021
In Mar. 2021, the Center for Drug Evaluation released a total of seven announcements including contents such as technical requirements for drug research & evaluation. ChemLinked BaiPharm team collected the documents and summarized their keynotes.
Apr 08, 2021
REGULATION
China Announces Technical Requirements for Overseas Approved Chemical Drugs Seeking Domestic Marketing Authorization
On Mar. 8, China Center of Drug Evaluation issued the Technical Requirements for CMC Studies and Evaluation of Overseas-approved Chemical Drugs without Domestic Marketing Authorization (Trial).
Mar 09, 2021