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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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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
Law & Regulation
Guideline
Pharmacopoeia
Reference Listed Drug (RLD)
Marketing Approval
NRDL
Drug Registration
COVID-19
GLP
Monthly Recap: China Pharmaceutical Regulatory Updates | January 2023
Check out the regulatory updates in Jan. 2023: 1. China Issues the 2022 National Reimbursement Drug List; 2. China Approves Two Homegrown Drugs for COVID-19; 3. China Releases Two Lists of RLDs; 4. China Issues GLP Certification Regulation; 5. China Rolls Out Pharmaceutical Guidelines; 6. Chinese Pharmacopoeia Commission Issues Drafts of Standards
Feb 06, 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
POLICY
China Levies Zero Tariff on Active Pharmaceutical Ingredients of COVID-19, Cancer, and Rare Disease Drugs
According to China's 2023 Tariff Adjustment Plan, tariffs are provisionally lowered to zero for 22 categories of active pharmaceutical ingredients of medicines for treating COVID-19, cancer, and rare diseases.
Jan 05, 2023
REGULATION
Law & Regulation
Guideline
Pharmacopoeia
Reference Listed Drug (RLD)
Clinical Trial
Bioequivalence (BE)
Generic Drug
New Drug
COVID-19
Monthly Recap: China Pharmaceutical Regulatory Updates | August 2022
Check out China's pharmaceutical regulatory updates in August: NMPA granted OTC status to Omeprazole Enteric-coated Tablets; NMPA released the 57th List of Reference Listed Drugs (RLDs); NHC Adds Azvudine to COVID-19 Diagnosis and Treatment Protocol; NMPA to Adopt ICH E8 (R1) and E14 Guidelines...
Sep 09, 2022
INDUSTRY
China's First Homegrown COVID-19 Pill, Azvudine, is Priced at 270 Yuan Per Bottle
China's first domestic oral drugs for COVID-19 treatment, Genuine Biotech's Azuvidine Tablets, is priced at no more than 300 yuan for each bottle, which contains 35 tablets (1mg/tablet). The recommended dosage is 5 mg (five 1mg tablets) per day for a course no longer than 14 days. Thus, a course of Azvudine costs no more than 600 yuan.
Aug 12, 2022
INDUSTRY
Marketing Approval
Priority Review
Innovative Drug
Generic Drug
Biological Product
Drug Registration
New Drug
COVID-19
Monthly Report: New Drug Approvals in China | July 2022
In July 2022, China NMPA approved 10 new drugs, including 8 chemical drugs and 2 biological products. Among the drugs, Genuine Biotech's Azvudine Tablets is the first homegrown oral drug to get NMPA’s approval for COVID-19 treatment.
Aug 05, 2022