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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
Post-market drug safety and risk management
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REGULATION
Laws & Regulations
Reference Listed Drug (RLD)
Marketing Approval
Priority Review and Approval
Innovative Drugs
Generic Drugs
Drug Registration
New Drugs
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
Gene Therapy
Drug Registration
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
INDUSTRY
Best-selling Ophthalmic Drugs in China | Market Wrap 2021
The year 2021 has seen a remarkable growth of the ophthalmic drug market in China. The market size of chemical drugs for eye diseases is estimated to exceed 3.5 billion yuan (circa 549 million USD), with a year-on-year growth of 1.89%.
Jan 10, 2022
REGULATION
Laws & Regulations
Pharmacopeia
MAH
Pharmacovigilance
Marketing Approval
Priority Review and Approval
Volume-Based Procurement
Top 10 BaiPharm Stories of China's Pharmaceutical Regulations | 2021 Recep
ChemLinked BaiPharm Portal has been delivering and decoding China's pharmaceutical regulations to help international drug makers access the Chinese market. Here are the 10 regulatory topics that our readers are most concerned about in 2021.
Jan 07, 2022
