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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
INDUSTRY
Marketing Approval Priority Review Innovative Drug Generic Drug Drug Registration
Monthly Report: New Drug Approvals in China | November 2023 In Nov 2023, China NMPA approved 20 new drugs, among which 15 are chemical drugs and 5 are biological products.
Nov 30, 2023
REGULATION
Pharmacopoeia Clinical Trial Bioequivalence (BE)
Monthly Recap: China Pharmaceutical Regulatory Updates | November 2023 Check out the latest pharma regulatory updates in China.
Nov 30, 2023
POLICY
Volume-based Procurement Generic Drug
[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
POLICY
OTC Drug E-commerce
Shanghai Pilots Cross-border E-commerce for Foreign Drugs and Medical Devices On June 12, 2023, Shanghai launched a pilot program for importing drugs and medical devices through cross-border e-commerce (CBEC). The pilot program will be operational until June 11, 2024.
Oct 30, 2023
REGULATION
Law & Regulation MAH GMP
China Tightens Regulation on Outsourced Manufacturing for Drug Marketing Authorization Holders (MAHs) On Oct. 23, 2023, China's NMPA issued the Notice on Enhancing the Supervision and Management of Outsourced Manufacturing for Drug Marketing Authorization Holders (MAHs), which took immediate effect.
Oct 26, 2023
POLICY
Bioequivalence (BE) Volume-based Procurement Generic Drug
China's 9th Volume-based Procurement (VBP) of Drugs to Impact Market Valued Over USD 2.32 Billion Out of the 42 drugs to be enrolled in China’s 9th VBP, the top 10 best-selling drugs accounted for approximately USD 2.32 billion in sales in 2022. Two drugs—the immediate-release dosage forms of rabeprazole and propofol injections—each exceeded 3.5 USD billion in last year’s sales.
Oct 20, 2023
REGULATION
Law & Regulation DMF API Drug Registration
China Enforces Regulation on API Registration Renewal On Oct. 13, 2023, China NMPA implemented the Notice of the Administration of Active Pharmaceutical Ingredient (API) Registration Renewal, which applies to APIs that have obtained approval numbers or approval notifications.
Oct 18, 2023
REGULATION
Reference Listed Drug (RLD) Clinical Trial Bioequivalence (BE) Generic Drug
China Requires ANDAs Without Reference Drugs to Demonstrate Clinical Value For generic candidates without reference listed drugs, China's NMPA requires the applicant to conducting CM) studies to prove the proposed generic drug’s equivalence to the marketed drug with the same API, assesses and demonstrates the proposed drug’s clinical value, and submits a communication application for having a type-III meeting with CDE.
Oct 17, 2023
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