In all critical stages in the drug life cycle, BaiPharm can provide specific
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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 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
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
