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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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REGULATION
China Releases New Guidelines for Drug Registration Review, Effective March 2025
On February 9, 2025, China's Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) released two new guidelines: the Guideline for Acceptance and Review of Chemical Drug Registration (Trial) and the Guideline for Acceptance and Review of Biological Product Registration (Trial).
Feb 19, 2025
REGULATION
Law & Regulation
Reference Listed Drug (RLD)
Marketing Approval
NRDL
OTC Drug
Drug Registration
China
Monthly Recap: China Pharmaceutical Regulatory Updates | January 2025
Check out the latest pharma regulatory updates in China: 1. China Releases Several Lists of Reference Listed Drugs (RLDs); 2. China NMPA Grants Two Rx-to-OTC Switches; 3. China Issues Appendices to GMP for Pharmaceutical Excipients and Packaging Materials; 4. China Introduces Revised Medical Devices Supervision and Administration Regulations...
Feb 18, 2025
REGULATION
China Introduces Revised Medical Devices Supervision and Administration Regulations
On January 7, 2025, China's National Medical Products Administration (NMPA) officially released the Medical Devices Supervision and Administration Regulations (Hereinafter referred to as the 2025 version), replacing the 2017 version.
Jan 22, 2025
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | December 2024
Check out the latest pharma regulatory updates in China: 1. China Releases Several Lists of Reference Listed Drugs (RLDs); 2. China NMPA Grants One Rx-to-OTC Switch; 3. China Announces Results of the 10th Round of Volume-Based Drug Procurement (VBP); 4. China Authorizes 5 Drugs for Inclusion in the CARE Plan...
Jan 22, 2025
REGULATION
China Issues Appendices to GMP for Pharmaceutical Excipients and Packaging Materials
On January 2, 2025, China's National Medical Products Administration (NMPA) released two appendices to the Good Manufacturing Practice for Pharmaceutical Products (2010 Revision), specifically targeting pharmaceutical excipients and packaging materials respectively. These appendices will come into effect on January 1, 2026. Before this date, manufacturers of pharmaceutical excipients and packaging materials must upgrade their facilities and enhance their quality management systems to fully comply with the new requirements.
Jan 03, 2025
REGULATION
Law & Regulation
Reference Listed Drug (RLD)
NRDL
Volume-based Procurement
Rare Disease
Drug Registration
China
Monthly Recap: China Pharmaceutical Regulatory Updates | November 2024
Check out the latest pharma regulatory updates in China: 1. China CDE Solicits Public Comments on the 88th RLD Lists; 2. China Strengthens Oversight of Contract Drug Manufacturing; 3. China Standardizes Qualifications of and Requirements for Domestic Responsible Persons Designated by Overseas MAHs; 4. China Launches the 10th Round of Volume-Based Drug Procurement (VBP)
Dec 12, 2024
REGULATION
China Standardizes Requirements for Domestic Responsible Persons Designated by Overseas MAHs
On November 14, 2024, China's National Medical Products Administration (NMPA) issued the Interim Provisions on the Management of Designated Domestic Responsible Persons by Overseas Marketing Authorization Holders (MAH) of Drugs.
Nov 19, 2024
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | October 2024
Check out the latest pharma regulatory updates in China: 1. China Releases Several Lists of Reference Listed Drugs (RLDs), 2. China Publishes Re-registration Requirements for Domestically Manufactured Drugs, 3. China Consults on Scope and Procedures for Bioequivalence Test Filings of Chemical Drugs, 4. China CDE Releases Dossier Requirements for the Transfer of Imported Preventive Biological Products to Domestic Production...
Nov 13, 2024
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | September 2024
Check out the latest pharma regulatory updates in China: 1. China CDE Solicits Public Comments on the 86th RLD Lists, 2.China Releases the Fifth List of Pediatric Drugs Encouraged for R&D, 3. China CDE Completes the Consultation on Q&A on Pharmaceutical Similarity Studies of Biosimilars; 4. China CDE Launches Patient-Centered Action for Rare Diseases Encouragement, 5. China NHSA Releases Expert Evaluation Results for Drugs Applied for Inclusion of 2024 NRDL
Oct 12, 2024
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | August 2024
Check out the latest pharma regulatory updates in China: 1. China CDE Solicits Public Comments on the 85th RLD Lists, 2. China NHSA Announces 440 Drugs Having Passed the Format Review for NRDL, 3. China NMPA Grants Five Rx-to-OTC Switches, 4. China Consults on the Overarching Regulation of Medical Devices, 5. China CDE Releases the 82nd RLD List...
Sep 12, 2024
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