A Look Back at 2023: Pharmaceutical Regulatory Updates in China
[Tuesday, 30th Jan 2024]
A Look Back at 2023: Pharmaceutical Regulatory Updates in China
Grace Wang

In 2023, China implemented a range of drug regulations, encompassing various aspects such as active pharmaceutical ingredient (API) registration renewal, the outsourcing of manufacturing by marketing authorization holders (MAHs), and drug inspection, among others.

Furthermore, China conducted the bidding process for its 9th national volume-based procurement (VBP) and engaged in price negotiations for the 2023 edition of the National Reimbursement Drug List (NRDL). These initiatives significantly influenced the pricing and market accessibility of pharmaceutical products. 

We are hosting this webinar to provide comprehensive coverage of the significant regulatory updates throughout the year. Our goal is to ensure pharma companies are well-informed when devising strategies to enter and expand within the Chinese market.


1. China’s Drug Regulatory System

1.1 Main regulators

1.2 Major laws and regulations

2. 2023 Regulatory Updates

2.1 Regulations


New regulation


l  Notice on Enhancing the Supervision and Management of Outsourced Manufacturing of Drug Marketing Authorization Holders


l  Notice on Chemical Active Pharmaceutical Ingredient Registration Renewal

Generic drug

l  Notice on Generic Drug Studies Without Reference Listed Drugs

l  Guidance for the Acceptance Review of Quality and Therapeutic Equivalence Evaluation Applications for Generic Drugs (Draft)


l  Procedures for Adjusting Reference Listed Drugs of Chemical Generic Drugs (Trial)

l  11 lists (63rd to 73rd) lists of reference listed drugs


l  Administrative Measures for Drug Inspections (Revision)

Drug standards

l  Administrative Measures for Drug Standards


l  Administrative Measures for Drug Good Laboratory Practice (GLP) Certification

2.2 Policies

And more…


  • Feel free to reach out to us with any questions you may have before, during, or after the webinar.

  • Following the conclusion of the webinar, we will upload the resources, including slides and recording, to this webpage.

  • In the event that you are unable to attend the live webinar, we still encourage you to register. Rest assured that we will promptly send you the link for downloading the resources as soon as they become available.

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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