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NEWS Monthly Recap: China Pharmaceutical Regulatory Updates | March 2021
NEWS Rapid Growth of Botulinum Toxin in China's Aesthetic Medicine Market
NEWS Drugs Marketed in Hong Kong Are Expected to Supply Patients Across the Greater Bay Area Soon
NEWS China Launches Medical Device Master File System
INSIGHTS Selection of 2019 China Center for Drug Evaluation Annual Report
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In all critical stages in the drug life cycle, BaiPharm can provide specific recommendations and actionable solutions to clients.
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Consulting of current regulation and policy
NMPA related application for clinical trial and marketing approval
Compliance support from product development to commercialization
Post-market drug safety and risk management
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POLICY
Marketing approval Clinical Trials
Clinical Real-World Data Pilot Program: Fast-Track Entry Pathway into China It usually takes at least three to five years for innovative new medical products to enter the Chinese market. However, procedure could be much shorter with the application supported by clinical RWD.
Apr 12, 2021
REGULATION
Laws & Regulations CDE Guidance Reference Listed Drug (RLD) CMC Clinical Trials Generic Drugs APIs
Monthly Recap: China Pharmaceutical Regulatory Updates | March 2021 In Mar. 2021, the Center of Drug Evaluation released a total of seven announcements including contents such as technical requirements for drug research & evaluation. ChemLinked BaiPharm team collected the documents and summarized their keynotes.
Apr 08, 2021
INDUSTRY
Marketing approval Biological Products
Rapid Growth of Botulinum Toxin in China's Aesthetic Medicine Market With the major function to reduce the appearance of skin wrinkle, botulinum toxin injection has become one of the most favorable aesthetic medicine products by Chinese customers.
Apr 07, 2021
INDUSTRY
Laws & Regulations Post-market
Adverse Drug Reaction in China: Important Numbers from 2020 Report In 2020, China's National Monitoring System of Adverse Drug Reaction (ADR) received a total number of 1.676 million reports of ADR events.
Mar 31, 2021
POLICY
Laws & Regulations Marketing approval Priority Review and Approval
Drugs Marketed in Hong Kong Are Expected to Supply Patients Across the Greater Bay Area Soon Patients in the Greater Bay Area can soon have access to the marketed drugs in Hong Kong's public hospitals.
Mar 29, 2021
REGULATION
Laws & Regulations
China Launches Medical Device Master File System On Mar. 12, 2021, China National Medical Products Administration (NMPA) announced guidance on filing medical device master files (MAFs), which specified content, format and procedures of this new MAF system. The announcement took effect on the same day.
Mar 26, 2021
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Latest Insights VIEW MORE >
Selection of 2019 China Center for Drug Evaluation Annual Report Selection of 2019 China Center for Drug Evaluation Annual Report