OUR SERVICE
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
Latest News
INDUSTRY
Marketing Approval
Priority Review and Approval
Innovative Drugs
Generic Drugs
Drug Registration
New Drugs
Monthly Report: New Drug Approvals in China | Aug. 2021
In Aug. 2021, China NMPA nodded for nine new drug products including Tislelizumab Injection, Apremilast Tablet and Nivolumab Injection.
Sep 14, 2021
REGULATION
China Rolls Out Measures to Establish Drug Patent Linkage System
China tries to balance the patent protection of innovative drugs and the development of generics. MAHs of innovative drugs can bring a lawsuit or apply for an administrative ruling to protect patents. The first generics that successfully challenge the registered innovative drugs can enjoy 12-month marketing exclusivity.
Jul 23, 2021
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | June 2021
The monthly recap is intended to bring you the dynamics of recent major laws and regulations issued by China drug regulators, including National Medical Products Administration (NMPA) and the Center for Drug Evaluation (CDE).
Jul 20, 2021
