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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
REGULATION
Law & Regulation CDE Guideline Pharmacopoeia MAH CMC Clinical Trial Bioequivalence (BE) Innovative Drug API Drug Registration E-commerce Packaging 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
REGULATION
Law & Regulation E-commerce
China Bans a List of Drugs from Online Sales: Vaccines, Anesthetics, and More The list of drugs banned online in China include vaccines, blood products, anesthetics, psychiatric drugs, toxic drugs for medical use, radioactive drugs, medical precursor chemicals, etc. The list takes effect on Dec. 1, 2022, the same day when the Administrative Measures for Supervising Online Sales of Drugs came into force.
Dec 08, 2022
INDUSTRY
Marketing Approval Innovative Drug Generic Drug Biological Product Cancer Cardiovascular Disease Vaccine Drug Registration New Drug
Monthly Report: New Drug Approvals in China | November 2022 In October 2022, China NMPA approved 14 new drugs, including 12 chemical drugs and 2 biological products.
Dec 05, 2022
INDUSTRY
Innovative Drug Cancer Cell Therapy Gene Therapy
China Pharma Industry Sees More M&A Deals In 2021, Chinese pharma companies participated in a total of 782 domestic and cross-border M&A deals, amounting to 34,436 million USD.
Dec 02, 2022
REGULATION
Law & Regulation Drug Registration
China Requires Electronic Submission of All Drug Registration Application Documents from Jan. 1, 2023 China NMPA requires that all documents for drug registration applications, as well as supplemental documents sent during the review, shall be submitted electronically in compact disks with no paper required, from Jan. 1, 2023.
Dec 02, 2022
REGULATION
Law & Regulation MAH OTC Drug
China Permits Online Sales of Prescription Drugs Nationwide On Dec. 1, 2022, China's Administrative Measures for Supervising Online Sales of Drugs takes effect, allowing the online sales of prescription drugs nationwide after regional pilot programs in Hainan and Shenzhen.
Dec 01, 2022
POLICY
Cancer Rare Disease
China to Cut VAT on the 3rd List of Anti-cancer and Rare Disease Drugs China will reduce the VAT to 3% for a list of anti-cancer drugs and rare disease / orphan drugs from Dec. 1, 2022.
Nov 25, 2022
INDUSTRY
Clinical Trial Cancer New Drug
Bispecific Antibody Becomes a Hotspot for Pharmaceutical Research in China In China, over 300 bispecific antibody (BsAb) drugs are being developed, among which nearly 100 have entered the clinical trial stage. By 2030, the Chinese BsAb market is expected to reach 10.8 billion USD.
Nov 25, 2022
INDUSTRY
Clinical Trial
Top 10 CROs Using China's Human Genetic Resources in International Clinical Trials From Jan. to Oct. 2022, among the 3,632 international clinical trials approved by China to use the its human genetic resources outside China, about 52% are conducted by contract research organizations (CROs) and about 48% by the applicants themselves.
Nov 23, 2022
REGULATION
Law & Regulation
China Announces New Classifications of Medical Sodium Hyaluronate Products China specifies the registration classifications of sodium hyaluronate products based on intended use (indication) and mechanism of action.
Nov 21, 2022
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