2022 Recap & 2023 Outlook: China Pharmaceutical Regulatory Updates

Feb. 28th, 2023

Grace Wang


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.


1. China’s Drug Regulatory System

1.1 Main regulators

1.2 Major laws and regulations

2. 2022 Regulatory Updates

2.1 Regulations

Topic New Regulation
MAH Administrative Rules on Supervising Marketing Authorization Holder (MAH) as the Main Entity to Fulfill Responsibilities for Drug Quality
GVP Pharmacovigilance Inspection Guidelines
GMP Appendix to Good Manufacturing Practice (GMP) for Pharmaceuticals: Investigational Products Used in Clinical Trials
GSP Appendix to Good Supply Practice (GSP) for Pharmaceuticals: Quality Management of Drug Retail Delivery
Online Sales Administrative Measures for Supervising Online Sales of Drugs
CBEC 2022 Updated Cross-border E-commerce (CBEC) Positive List

2.2 Policies

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


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


Grace Wang

ChemLinked Regulatory Analyst / Editor

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.

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