News
Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
Hot topic
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
PIPELINE
Chinese Antibody-drug Conjugates (ADCs) Licensed Overseas Exceeds $23 Billion This Year
On Dec 20, 2023, Hansoh Pharma, a Chinese biopharma company, announced that it had reached an exclusive deal with GSK for HS-20093, an antibody-drug conjugate (ADC) targeting B7-H3. This deal is one of 15 cross-border licensing deals inked this year between Chinese ADC-focused companies and multinational corporations this year.
Dec 21, 2023
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
Monthly Recap: China Pharmaceutical Regulatory Updates | November 2023
Check out the latest pharma regulatory updates in China: 1. China NMPA Applies for PIC/S Membership; 2. China to Adopt System for E2B (R3) Electronic Transmission of ICSRs; 3. China NMPA Grants Three Rx-to-OTC Switches; 4. China Includes 195 Drug Products in Its 9th National VBP; 5. China NMPA Issues Inspection Regulation on Clinical Trial Institutions; 6. China NMPA Consults on Anesthetics and Psychotropics Regulations; 7. China CDE Releases Pharmaceutical Guidelines; 8. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards
Nov 30, 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
