News
Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
Hot topic
REGULATION
Law & Regulation
Guideline
Pharmacopoeia
Innovative Drug
Generic Drug
Rare Disease
Cell Therapy
Gene Therapy
Monthly Recap: China Pharmaceutical Regulatory Updates | September 2023
China pharma regulatory updates in Sept. 2023: 1. NMPA Publishes the 2022 China Drug Evaluation Report; 2. NHC Releases the 2nd Catalog of Rare Diseases; 3. NMPA Adjusts Anesthetic and Psychotropic Drug Catalogs; 4. CDE Unveils 2022 Report on the Progress of New Drug Clinical Trials in China; 5. NMPA Grants Three Rx-to-OTC Switches; 6. ICH, NMPA, and CDE Release Pharmaceutical Guidelines; 7. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards
Oct 08, 2023
INDUSTRY
Marketing Approval
Priority Review
Innovative Drug
Generic Drug
Biological Product
Cancer
Diabetes
Drug Registration
New Drug
Monthly Report: New Drug Approvals in China | June 2023
In June 2023, China NMPA approved 33 new drugs, among which 26 are chemical drugs while 7 are biological products.
Jul 07, 2023
INDUSTRY
Marketing Approval
Innovative Drug
Generic Drug
Biological Product
Cancer
Diabetes
Vaccine
Drug Registration
New Drug
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
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
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
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
Most Popular
- Monthly Report: New Drug Approvals in China | February 2024
- Monthly Recap: China Pharmaceutical Regulatory Updates | February 2024
- 2023 China CDE Drug Evaluation Report
- [Updated] China Expedites Process for Transferring Overseas Drug Manufacturing Sites to China
- Monthly Report: New Drug Approvals in China | March 2024