INSIGHTS China DMF Filing, Review & Approval System for APIs, Pharmaceutical Excipients & Packaging Materials
In all critical stages in the drug life cycle, BaiPharm can provide specific recommendations and actionable solutions to clients.VIEW MORE >
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
China Takes New Measures for GMP & GSP Inspection China has cancelled the GMP and GSP certification since it implemented Drug Administration Law in 2019. Now, the drug manufacturing and supply activities in the country will be inspected according to Administrative Measures on Drug Inspection (Trial).
Jun 15, 2021
China to Pilot Cross-Border E-Commerce Retail Import of Drugs China recently approved Henan Province’s cross-border e-commerce pilot program for importing drugs and medical devices, starting with 13 OTC medicines licensed in China. Thanks to the pilot program, more overseas drugs, including anti-cancer and targeted therapy drugs, stand a chance of accessing the Chinese market. This article focuses on drug import as part of the pilot program.
Jun 04, 2021
China Implements the Newly Released Good Pharmacovigilance Practice The Chinese GVP applies to Marketing Authorization Holders’s pharmacovigilance activities about medicinal products and drug registration applicants with authorization to carry out clinical trials.
May 28, 2021
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China DMF Filing, Review & Approval System for APIs, Pharmaceutical Excipients & Packaging Materials China DMF Filing, Review & Approval System for APIs, Pharmaceutical Excipients & Packaging Materials
New Market Entry Pathways of Medical Products: Special Medical Zones in China New Market Entry Pathways of Medical Products: Special Medical Zones in China