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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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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 | 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
POLICY
China Promotes the Development of 39 Generics to Meet Domestic Clinical Needs
On Dec 25, 2023, China issued the 3rd list of encouraged generic drugs. The list comprises 39 drugs based on their active ingredients, encompassing a total of 75 different strengths. The foremost purpose for releasing this list is to address the clinical needs within the country.
Dec 27, 2023
POLICY
[Updated] China's 9th Volume-based Procurement (VBP) Includes 195 Products
On Nov 6, 2023, China announced the preliminary results of the bid for the 9th national volume-based procurement (VBP), a bulk-purchase program for supplying medicines to public healthcare institutions. 266 products (41 drugs if classified by active ingredients) from 205 companies won the bid.
Nov 17, 2023
REGULATION
Law & Regulation
Pharmacopoeia
CMC
Clinical Trial
Bioequivalence (BE)
Generic Drug
Biological Product
New Drug
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
INDUSTRY
Marketing Approval
Innovative Drug
Generic Drug
Biological Product
Cancer
Rare Disease
Drug Registration
New Drug
Respiratory Disease
Monthly Report: New Drug Approvals in China | October 2023
In Oct 2023, China NMPA approved 15 new drugs, among which 12 are chemical drugs and 3 are biological products: 1. BMS’ Deucravacitinib Tablets (SOTYKTU); 2. Pfizer’s Ritlecitinib Tosylate Capsules (LITFULO); 3. Janssen-Cilag International’s Rilpivirine Injection; 4. Luye Pharma’s Rivastigmine Twice Weekly Transdermal Patch; 5. Abbvie’s Upadacitinib Sustained-release Tablets (RINVOQ)...
Nov 06, 2023
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