| Date | Time (GMT+8) | World Clock | Language |
| 2024-01-30 | 21:00 ~ 22:00 | New York: 8:00-9:00 London: 13:00-14:00 |
English |
A Look Back at 2023: Pharmaceutical Regulatory Updates in China
Jan. 30th, 2024
Grace Wang
Free
Background
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.
Related Links:
Contents
1. China’s Drug Regulatory System
1.1 Main regulators
1.2 Major laws and regulations
2. 2023 Regulatory Updates
2.1 Regulations
| Topic | New regulation |
| MAH | Notice on Enhancing the Supervision and Management of Outsourced Manufacturing of Drug Marketing Authorization Holders |
| API | Notice on Chemical Active Pharmaceutical Ingredient Registration Renewal |
| Generic drug | Notice on Generic Drug Studies Without Reference Listed Drugs
Guidance for the Acceptance Review of Quality and Therapeutic Equivalence Evaluation Applications for Generic Drugs (Draft) |
| RLD | Procedures for Adjusting Reference Listed Drugs of Chemical Generic Drugs (Trial)
11 lists (63rd to 73rd) lists of reference listed drugs |
| Inspection | Administrative Measures for Drug Inspections (Revision) |
| Drug standards | Administrative Measures for Drug Standards |
| GLP | Administrative Measures for Drug Good Laboratory Practice (GLP) Certification |
2.2 Policies
- The 9th National Volume-based Procurement (VBP)
- 2023 National Reimbursement Drug List (NRDL)
- List of Pediatric Drugs Encouraged for Development and Application
And more…
Notes:
- Feel free to contact 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 recordings, to this webpage.
- If 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.
Schedule
Speaker
Grace Wang
ChemLinked Regulatory Analyst & Editor
Contact REACH24H
If you have any questions regarding this webinar, please feel free to contact us.
Tel: +86 400 809 5809
Email: customer@reach24h.com
