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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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INDUSTRY
China's Pharmaceutical Industry Expected to Be the World's Largest in Less Than 10 Years
As of 2021, China holds 12% of the global pharmaceutical market, following the United States, responsible for 40% of the total revenue worldwide. Chinese pharma market is reported to have generated 708.75 billion yuan in 2021, while Chinese domestic pharma companies amassed 502 billion USD (3.37 trillion RMB) in revenue.
Jul 28, 2022
REGULATION
Law & Regulation
Guideline
Reference Listed Drug (RLD)
Marketing Approval
Bioequivalence (BE)
OTC Drug
Gene Therapy
Drug Registration
New Drug
Monthly Recap: China Pharmaceutical Regulatory Updates | December 2021
1. China Approves Its First COVID-19 Therapy; 2. China to Decide Whether to Conduct Pre-Approval Inspections Based on Risk Levels; 3. China NMPA Adjusts Over-the-Counter (OTC) Catalog; 4. China NMPA Releases the 49th Batch of Reference Listed Drugs (RLDs); 5. For Medical Devices: Class I Catalog, Emergency Approval Procedures, and Industry Standards; 6. Pharmaceutical Guidelines
Jan 13, 2022
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | November 2021
1. China Insulin VBP Tender Result;
2. NMPA Launches Drug Supply Information Submission System;
3. NMPAs Requires Documentation for Import/Export Permit of Analgesics and Antipsychotics;
4. NMPA Announces One Rx-to-OTC Switch;
5. The 48th Batch of Reference Listed Drugs;
6. NMPA Approves 110 Medical Devices;
7. NHC Releases Administrative Measures for National Essential Medicine List (Revised Draft);
8. NMPA Releases Administrative Measures for Quality Supervision in Drug Supply, Distribution and Use (Consultation Draft)...
Dec 16, 2021
POLICY
China to Pilot Cross-Border E-Commerce Retail Import of Drugs
China recently approved Henan Province’s cross-border e-commerce pilot program for importing drugs and medical devices, starting with 13 OTC medicines licensed in China. Thanks to the pilot program, more overseas drugs, including anti-cancer and targeted therapy drugs, stand a chance of accessing the Chinese market. This article focuses on drug import as part of the pilot program.
Jun 04, 2021