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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
EDQM: Supplement 11.2 of the European Pharmacopoeia Available
Supplement 11.2 of the European Pharmacopoeia (Ph.Eur.) is now available. This supplemental edition lists several updated monographs that will be implemented on 01 July 2023. All CEP holders (Certificate of Suitability of Monographs of the European Pharmacopoeia holders) are encouraged to align their specifications and thus the respective CEPs to the new monographs.
Mar 09, 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
PIPELINE
2022’s Top 10 Cross-border Licensing Deals Involving Chinese Biopharma Companies
Compared with 2021, 2022 was not a thriving year for cross-border licensing deals involving Chinese biopharmaceutical companies. From 2021 to 2022, the number of in-licensing deals dropped from 128 to 90 with total value slumping from 15.55 billion USD to 5.84 billion USD. The out-licensing deals focused on tumor therapy. The top megadeal worth 9.475 billion USD was inked between Kelun Industry Group and MSD.
Feb 24, 2023
REGULATION
BaiPharm Regulatory Database Is Online: A Useful Tool to Search for China’s Pharma Guidelines, Regulations, and Standards
ChemLinked BaiPharm Regulatory Database is a useful tool for ChemLinked users, especially overseas pharmaceutical companies that aim for China market, to search for China’s official guidelines, regulations, and Chinese Pharmacopoeia standards.
Feb 16, 2023
REGULATION
Law & Regulation
CDE 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
