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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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REGULATION
Law & Regulation
Guideline
Marketing Approval
Priority Review
NRDL
Health Insurance
Rare Disease
Drug Registration
Real World Data
The 16th Rare Disease Day: China's Efforts to Make Orphan Drugs Available and Affordable
This year’s Feb. 28 marks the 16th International Rare Disease Day. In China, there are around 20 million rare disease patients, with more than 200,000 additional patients each year. China has shown a supportive attitude towards rare disease drug development in a series of official documents. The regulations and policies introduced in this article are significant in terms of the drugs’ marketing authorization review timeline and pricing.
Mar 10, 2023
REGULATION
Pharmacopoeia
MAH
Marketing Approval
CMC
Clinical Trial
Bioequivalence (BE)
NRDL
Drug Registration
New Drug
Real World Data
Packaging
Monthly Recap: China Pharmaceutical Regulatory Updates | February 2023
China's regulatory updates in Feb. 2023: 1. China NMPA Issues TCM Registration Rules; 2. China CDE Rolls Out Pharmaceutical Guidelines; 3. Chinese Pharmacopoeia Commission Issues Draft Standards
Mar 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
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
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
INDUSTRY
Marketing Approval
Innovative Drug
Generic Drug
Biological Product
Cancer
Cardiovascular Disease
Vaccine
Drug Registration
New Drug
Monthly Report: New Drug Approvals in China | November 2022
In October 2022, China NMPA approved 14 new drugs, including 12 chemical drugs and 2 biological products.
Dec 05, 2022
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