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WEBINARS MORE >
China's Quality and Therapeutic Equivalence Evaluations of Generic Drugs
[ Tuesday ,20th September 2022 ]
Understanding Chinese Pharmacopoeia (ChP) 2020
[ Wednesday ,15th June 2022 ]
Decoding China's Drug Marketing Authorization Holder (MAH) System
[ Tuesday ,31st May 2022 ]
How to Sell OTC Drugs to China via Cross-border E-commerce
[ Wednesday ,27th April 2022 ]
How to Submit Documents with Real-World Data to FDA To facilitate FDA’s internal tracking of submissions that include real-world data (RWD), the agency published a guidance on how to identify the use of RWD in submission cover letters.
Sep 21, 2022
China Permits Online Sales of Prescription Drugs Nationwide On Sept. 1, 2022, China SAMR published the Administrative Measures for Supervising Online Sales of Drugs, which will take effect on Dec. 1, 2022. After regional pilot programs in Hainan and Shenzhen, China finally allows the online sales of prescription drugs nationwide.
Sep 14, 2022
Law & Regulation CDE Guideline Pharmacopoeia Reference Listed Drug (RLD) Clinical Trial Bioequivalence (BE) Generic Drug New Drug COVID-19Monthly Recap: China Pharmaceutical Regulatory Updates | August 2022 Check out China's pharmaceutical regulatory updates in August: NMPA granted OTC status to Omeprazole Enteric-coated Tablets; NMPA released the 57th List of Reference Listed Drugs (RLDs); NHC Adds Azvudine to COVID-19 Diagnosis and Treatment Protocol; NMPA to Adopt ICH E8 (R1) and E14 Guidelines...
Sep 09, 2022
MAH Marketing Approval Priority Review and Approval Innovative Drug Generic Drug Biological Product Diabetes Rare Disease Drug Registration New DrugMonthly Report: New Drug Approvals in China | August 2022 In August 2022, China NMPA approved 13 new drugs, including 9 chemical drugs and 4 biological products. Among them, MSD's HPV 9-valent vaccine got approval to expand the target group from females 16-26 years of age to 9-45 years of age.
Sep 09, 2022
Understanding 42 Guidelines in the Chinese Pharmacopoeia The Chinese Pharmacopoeia 2020 Edition includes 361 general chapters, including 38 general requirements for preparations, 281 testing methods and other general chapters, and 42 guidelines.
Aug 30, 2022