In 2022, China issued and implemented a series of drug regulations, including new rules for marketing authorization holders to manage drug quality and guidelines for pharmacovigilance inspections. Last year also saw China’s first regulation permitting online sales of prescription drugs nationwide.
The regulations impact how pharmaceutical companies apply for marketing authorization, sell drug products, ensure drug safety, and fulfill other obligations. ChemLinked BaiPharm Team holds this webinar to review the significant regulatory updates, which can help stakeholders keep compliant with current regulations and prepare for the upcoming ones.
Contents
1. China’s Drug Regulatory System
1.1 Main regulators
1.2 Major laws and regulations
2. 2022 Regulatory Updates
2.1 Regulations
2.2 Policies
- The 7th Volume-based Procurement
- National Reimbursement Drug List (NRDL) Update
- Tax Reduction for Anti-cancer and Rare Disease Drugs
3. 2023 Outlook
3.1 China’s pharma market outlook
3.2 Preparing for the emerging regulations
Note: The contents may be slightly adjusted.
Search for China’s Pharma Regulations in BaiPharm Regulatory Database
Schedule
| Date | Time (GMT +8) | World Clock | Language |
| 2023-02-28 | 21:00 ~ 22:00 | London: 13:00-14:00 New York: 8:00-9:00 |
English |
Speaker
Grace Wang
Grace Wang is a regulatory analyst and editor specializing in China’s pharmaceutical regulations and market trends. She provides news and insights to help overseas pharma companies enter the Chinese market. Her areas of focus include DMF filing, new drug application, pharmacovigilance, and the volume-based procurement policy.
