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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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Monthly Report: New Drug Approvals in China | May 2023
In May 2023, China NMPA approved 27 new drugs, among which 16 are chemicals and 11 are biologics: 1. Betta Pharma’ Befotertinib Mesylate Capsules; 2. Sanhome Pharma’s Alfosbuvir Tablets; 3. Novartis’ Ribociclib Succinate Tablets...
Jun 12, 2023
REGULATION
Law & Regulation
Guideline
Reference Listed Drug (RLD)
Marketing Approval
CMC
Clinical Trial
Bioequivalence (BE)
Generic Drug
Drug Registration
China May Disallow Applications of Generic Drugs with No RLDs and Low Clinical Value
On May 24, China CDE released the draft Notice of Generic Drug Study Without Reference Listed Drugs (RLDs). The draft states the precondition for developing copycats of drugs which are not listed in China’s RLD Catalog—the drugs have to be widely used, with no alternatives, and with benefits trumping risks.
Jun 05, 2023
POLICY
What's New About China's 8th Volume-based Procurement (VBP) of Drugs
China's 8th medical volume-based procurement (VBP) covers 39 drugs (number based on generic name) with an average price cut of 56%, estimated to save 1.67 million yuan (circa 240,000 USD) annually based on the planned procurement volumes.
Apr 26, 2023
INDUSTRY
Monthly Report: New Drug Approvals in China | March 2023
In Mar. 2023, China NMPA approved 15 new drugs, which are all chemical drugs. 1. Raynovent’s Leritrelvir Tablets 2. Shanghai Haihe Biopharma’s Glumetinib Tablets 3. IPSEN PHARMA’s Triptorelin Pamoate for Injection 4. AstraZeneca’s Acalabrutinib Capsules (CALQUENCE) 5. Nobelpharma’s Sirolimus Gel (HYFTOR)...
Apr 07, 2023
REGULATION
China May Delist Ineligible Reference Listed Drugs (RLDs) of Chemical Generic Drugs
On Mar. 24, 2023, China NMPA released the Procedures for Adjusting Reference Listed Drugs (RLDs) of Chemical Generic Drugs (Trial) with immediate effect. RLDs are reference drugs to which generic drugs should be equivalent in safety and efficacy. NMPA finds that some listed RLDs no longer meet the Chinese Pharmacopoeia standards or the current technological requirements. That’s why NMPA formulates and implements the RLD Adjustment Procedures.
Mar 28, 2023
INDUSTRY
Marketing Approval
Innovative Drug
Generic Drug
Biological Product
Cancer
Vaccine
Drug Registration
New Drug
Monthly Report: New Drug Approvals in China | February 2023
In Feb. 2023, China NMPA approved 13 new drugs, including 9 chemical drugs and 4 biological products. 1. Carephar’s Keverprazan Hydrochloride Tablets 2. Novartis’ Revolade 3. Pfizer’s Xeljanz XR 4. Vifor Fresenius’ Velphoro 5. Swedish Orphan Biovitrum’s Orfadin (capsule) 6. Swedish Orphan Biovitrum’s Orfadin (oral suspension) 7. Gilead Sciences’ AmBisome 8. AbbVie’s RINVOQ 9. Tide Pharma’s Limaprost Alfadex Tablets 10. BeiGene’s Tislelizumab Injection 11. Daiichi-Sankyo’s ENHERTU 12. Amgen’s Prolia 13. Sanofi Pasteur’s Influenza Vaccine (Split Virion), Inactivated, Quadrivalent
Mar 03, 2023
INDUSTRY
Marketing Approval
Priority Review
Innovative Drug
Generic Drug
Biological Product
Cancer
Drug Registration
New Drug
COVID-19
Monthly Report: New Drug Approvals in China | January 2023
In January 2023, China NMPA approved 15 new drugs, including 8 chemical drugs and 7 biological products. Simcere's Simnotrelvir Tablets / Ritonavir Tablets and Shanghai Vinnerna Biosciences' Deuremidevir Hydrobromide got conditional approvals for COVID-19 treatment.
Feb 03, 2023
REGULATION
Law & Regulation
Pharmacovigilance
Marketing Approval
Volume-based Procurement
Generic Drug
Drug Registration
E-commerce
2022 Recap: Top 10 BaiPharm Stories on China Pharmaceutical Regulations
ChemLinked BaiPharm Portal has been tracking and interpreting China’s pharmaceutical regulations during the year of 2022. Here are the top 10 stories we selected for you to grasp China’s regulatory dynamics.
Jan 13, 2023