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WEBINARS
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Investigational New Drug (IND) Preparation for U.S. FDA Submission
[ Thursday, 26th September 2024 ]
Understanding Regulatory Requirements for Exporting Drugs to Cambodia, Laos, and Myanmar
[ Wednesday, 13th December 2023 ]
Understanding Regulatory Requirements for Exporting Drugs to Indonesia and Vietnam
[ Thursday, 30th November 2023 ]
LATEST NEWS
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
POLICY
China Announces Results of the 10th Round of Volume-Based Drug Procurement (VBP)
China's National Joint Drug Procurement Office has unveiled the results of the 10th round of the Volume-Based Drug Procurement (VBP). The implementation of the selected drugs will commence in April 2025, with the specific start dates depending on provincial notifications.
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
