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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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REGULATION
Law & Regulation
MAH
Pharmacovigilance
Marketing Approval
Priority Review and Approval
Medical Insurance
Innovative Drug
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Rare Disease
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New Drug
China Encourages Innovative Drug R&D in Revised Draft of Regulations for Implementing the Drug Administration Law
Find out the highlights in revised draft of the Regulations for Implementation of the Drug Administration Law: pharmaceutical innovation, acceptance of foreign clinical data, support the development of pediatric and rare disease drugs...
May 13, 2022

INDUSTRY
MAH
Marketing Approval
Priority Review and Approval
Innovative Drug
Generic Drug
Biological Product
Cancer
Drug Registration
New Drug
Monthly Report: New Drug Approvals in China | April 2022
In April 2022, China NMPA approved 23 new drugs, including 20 chemical drugs and 3 biological products.
May 12, 2022

INDUSTRY
Marketing Approval
Priority Review and Approval
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
Medical 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 and Approval
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

REGULATION
Law & Regulation
CDE Guideline
Reference Listed Drug (RLD)
Marketing Approval
DMF
Biological Product
API
Drug Registration
New Drug
Monthly Recap: China Pharmaceutical Regulatory Updates | February 2022
1. CDE Releases its Work Procedures for Expediting the Review of Marketing Applications of Innovative Drugs (Trial);
2. CDE Consults on the Guidance for Acceptance Review of Active Pharmaceutical Ingredients (API) of Chemical Drugs;
3. CDE Releases the Consultation Draft of Guidance for Acceptance Review of Registration Applications of Traditional Chinese Medicines, Chemical Drugs, and Biological Products (Trial);
4. NMPA Releases the 51st List of Reference Listed Drugs;
5. NMPA Publishes the 2022 Plan for Random Inspection of Medical Devices;
6. NMPA Reveals the List of 208 Medical Devices Approved in January 2022;
7. Guidelines for Pharmaceutical Industry.
Mar 10, 2022

REGULATION
Law & Regulation
Marketing Approval
Priority Review and Approval
Innovative Drug
Drug Registration
New Drug
China to Expedite Marketing Approval of Innovative Drugs
China CDE plans to expedite the marketing approval of inovative drugs with Breakthrough Therapy Designation (BTD). Technical review will be completed within 130 workdays for the innovative BTD drugs' marketing applications.
Mar 03, 2022
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