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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
REGULATION
Law & Regulation CDE Guideline Marketing Approval Priority Review and Approval 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 EU
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
POLICY
NRDL Health Insurance New Drug COVID-19
[Updated] China Adds 111 Drugs to 2022 National Reimbursement Drug List On Mar. 1, 2023, China starts to implement the 2022 National Reimbursement Drug List (NRDL), a list of drugs fully or partially reimbursed by the national basic health insurance.
Mar 01, 2023
PIPELINE
Biological Product Cancer Cardiovascular Disease License in/out
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
Law & Regulation CDE Guideline Pharmacopoeia
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
INDUSTRY
Marketing Approval Priority Review and Approval 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
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