2022 Recap & 2023 Outlook: China Pharmaceutical Regulatory Updates
[Tuesday, 28th Feb 2023]
2022 Recap & 2023 Outlook: China Pharmaceutical Regulatory Updates
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 stages 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


New Regulation


Administrative Rules on Supervising Marketing Authorization Holder (MAH) as the Main Entity to Fulfill Responsibilities for Drug Quality

Electronic Submission/


NMPA Announcement on the Electronic Submission of Drug Registration Applications

NMPA Announcement on Issuing Electronic Drug Registration Certificates


Pharmacovigilance Inspection Guidelines

Administrative Measures for Drug Recall

MedDRA Coding Guidance for Drug Marketing Authorization Holders (MAH)


Appendix to Good Manufacturing Practice (GMP) for Pharmaceuticals: Investigational Products Used in Clinical Trials

Online Sales

Administrative Measures for Supervising Online Sales of Drugs

NMPA Announcement on Information Filing and Reporting for Online Drug Sales

List of Drug Banned from Online Sales (1st Version)


Appendix to Good Supply Practice (GSP) for Pharmaceuticals: Quality Management of Drug Retail Delivery


Administrative Rules on Vaccine Manufacture and Distribution

Product Classification

Administrative Classifications of Medical Sodium Hyaluronate Products


13 (50th-62nd) lists of reference listed drugs


11 Rx-to-OTC switches

Documentation Requirements for Prescription (Rx) to Over-the-counter (OTC) Switch Applications

A Series of Guidelines

Technical Guidelines on the Evaluation of Immune-related Adverse Events (irADR) in Immuno-oncology



2022 Updated Cross-border E-commerce (CBEC) Positive List

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

Search for China's Pharma Regulations in BaiPharm Regulatory Database

Grace Wang
ChemLinked Regulatory Analyst & Editor
Grace has been covering China's economic, business, and cultural activities after graduating from Nanjing University. She joined in REACH24H Consulting Group as a regulatory analyst and editor, focusing on China's pharmaceutical regulations and markets. Her articles and webinars decode regulations & policies on DMF, NDA, ANDA, pharmacovigilance, health insurance, and volume-based procurement, as well as the Chinese pharma industry in terms of market trend, cross-border licensing deals, and specific products.
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