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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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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
REGULATION
Laws & Regulations
CDE Guidance
Reference Listed Drug (RLD)
Marketing Approval
Bioequivalence (BE)
OTC Drugs
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New Drugs
Monthly Recap: China Pharmaceutical Regulatory Updates | Dec 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 | Nov. 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
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | March 2021
In Mar. 2021, the Center for Drug Evaluation released a total of seven announcements including contents such as technical requirements for drug research & evaluation. ChemLinked BaiPharm team collected the documents and summarized their keynotes.
Apr 08, 2021
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- Monthly Recap: China Pharmaceutical Regulatory Updates | Nov. 2021
- China's Insulin VBP Saw Average Price Cut of 48.75%
- Monthly Report: New Drug Approvals in China | Nov. 2021
