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Consulting of current regulation and policy
NMPA related application for clinical trial and marketing approval
Compliance support from product development to commercialization
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Latest News
POLICY
China Adds 74 Drugs to National Reimbursement Drug List (NDRL)
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
INDUSTRY
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
POLICY
China's Insulin VBP Saw Average Price Cut of 48.75%
China’s insulin VBP (volume-based procurement)--eleven drug makers won the bid to supply insulin products to public healthcare institutions across China. Among 42 bid-winner products, Novo Nordisk took the champion with seven products. Two local Chinese companies—Gan & Lee and the United Laboratories—took the second and third places with six products respectively.
Dec 06, 2021
REGULATION
China Cracks Down on Monopolies in Active Pharmaceutical Ingredient Industry
On Nov. 18, China issued the Anti-Monopoly Guidance for Active Pharmaceutical Ingredients, clarifying regulations against monopoly agreements, abuse of market power, and concentration of undertakings in the API industry.
Nov 26, 2021
INDUSTRY
Laws & Regulations
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MAH
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Innovative Drugs
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New Drugs
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
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | Oct. 2021
China’s Pharma Regulatory Dynamics in Oct. 2021
1. NMPA Releases IVD Reagent Classification Rules
2. NMPA Greenlights 195 Medical Devices
3. NMPA Publishes Medical Device’s Self-Inspection Rules
4. NMPA Rolls Out the 45th, 46th, and 47th Batches of Reference Listed Drugs
5. NHC Consults on Detailed Rules on the Supervision of Internet-based Diagnosis
6. CDE Releases Pharmaceutical Guidelines
Nov 11, 2021
