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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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POLICY
China Emphasizes Rare Disease & Pediatric Drugs in Adjusting the 2022 National Reimbursement Drug List (NRDL)
On June 29, 2022, China NHSA issued the Work Plan for Adjusting the 2022 National Reimbursement Drug List (NRDL). NRDL is a list of drugs covered by the basic national insurance for healthcare, employment injury, and maternity.
Jul 04, 2022
REGULATION
Law & Regulation
Guideline
Reference Listed Drug (RLD)
MAH
Pharmacovigilance
Marketing Approval
CMC
Bioequivalence (BE)
Post-market
Generic Drug
Biosimilar
Cancer
New Drug
Monthly Recap: China Pharmaceutical Regulatory Updates | April 2022
Check out China's pharmaceutical regulation updates April 2022: China NMPA releases Pharmacovigilance Inspection Guidelines...
May 05, 2022
INDUSTRY
Marketing Approval
Priority Review
Innovative Drug
Generic Drug
Biological Product
Cancer
Cardiovascular Disease
Rare Disease
Drug Registration
New Drug
Monthly Report: New Drug Approvals in China | March 2022
In March 2022, China NMPA approved 23 new drugs, including 15 chemical drugs and 8 biological products.
Apr 07, 2022
POLICY
Law & Regulation
Marketing Approval
Volume-based Procurement
Health Insurance
Innovative Drug
Cancer
Cardiovascular Disease
Rare Disease
Drug Registration
New Drug
China's 2022 Two Sessions: Goals and Proposals for Pharma & Healthcare Industry
China's Government Work Report says one off the major tasks for 2022 is to improve medical and health services.
Mar 15, 2022
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 | February 2022
In February 2022, China NMPA approved 16 new drugs, including 12 chemical drugs and 4 biological products. Among the newly approved drugs, Pfizer’s Paxlovid is the first foreign drug against COVID-19 to receive marketing authorization in China.
Mar 11, 2022
POLICY
China Adds 74 Drugs to National Reimbursement Drug List (NRDL)
On Dec. 3, China released its 2021 National Reimbursement Drug List (NRDL). NRDL is a list of drugs allowable for reimbursement by the national social health insurance fund under the social security system which has covered more than 1.36 billion people in China by the end of 2020.
Dec 08, 2021
PIPELINE
Are Cross-Border Licensing Deals a Shortcut to China's Pharma Market?
In 2021 H1, China has made 50 in-licensing deals, among which the top 10 add up to $5,197.5 million in value. Licensing deals do have advantages for promoting foreign drugs in China, but they are not shortcuts. Prudent work still needs to be done before making the deals.
Dec 07, 2021