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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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REGULATION
Law & Regulation
Reference Listed Drug (RLD)
Marketing Approval
Priority Review
Innovative Drug
Generic Drug
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New Drug
How Will China Regulate and Boost Pharmaceutical Industry by 2025
At the end of 2021, China announced its National Plan for Promoting Drug Safety and the High-quality Development of the Pharmaceutical Industry during the 14th Five-Year Plan (2021-2025). To realize the 2035 vision which includes an internationally-advanced drug regulatory system, China sets tasks to be completed by 2025.
Jan 14, 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
INDUSTRY
Law & Regulation
Pharmacopoeia
MAH
Pharmacovigilance
Marketing Approval
Innovative Drug
Drug Registration
New Drug
CRAC-HCF 2021 | Embracing China's Pharma Market With Regulatory Compliance and Industry Insights
Five experts from drug regulation authorities, pharmaceutical companies, and consulting firms decoded drug regulations and analyzed industry dynamics for international pharma companies to develop businesses in the Chinese market.
Nov 17, 2021
INDUSTRY
Marketing Approval
Priority Review
Innovative Drug
Generic Drug
Biological Product
Biosimilar
Drug Registration
New Drug
Monthly Report: New Drug Approvals in China | Oct. 2021
In Oct. 2021, China's NMPA granted marketing authorization approvals to 11 new drugs, including Takeda's VOCINTI and Sanofi's Clopidogrel Bisulfate and Aspirin Tablets.
Nov 08, 2021
INDUSTRY
Marketing Approval
Innovative Drug
Generic Drug
Biological Product
Biosimilar
Drug Registration
New Drug
Monthly Report: New Drug Approvals in China | Sept. 2021
In Sept. 2021, China's NMPA granted 13 new drug approvals, including for Sanofi-Aventis Groupe's Dupilumab Injection and Merck's Pembrolizumab Injection.
Oct 25, 2021