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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
China Implements Guidelines on Immune-related Adverse Event (irADR) in Immuno-oncology In the Guidelines, China CDE proposes the definition of irAE as all levels of adverse drug reactions (ADR) that are confirmed to have causal connections with the immune mechanism.
May 20, 2022
China Releases MedDRA Coding Guidance for Adverse Drug Reaction (ADR) Reports MedDRA is a standardized medical terminology developed by the ICH. China's Guidance is for MAHs to use MedDRA coded terms in post-marketing adverse reaction reports.
May 18, 2022
Law & Regulation MAH Pharmacovigilance Marketing Approval Priority Review and Approval Medical Insurance Innovative Drug Generic Drug Rare Disease Drug Registration New DrugChina Encourages Innovative Drug R&D in Revised Draft of Regulations for Implementing the Drug Administration Law Find out the highlights in revised draft of the Regulations for Implementation of the Drug Administration Law: pharmaceutical innovation, acceptance of foreign clinical data, support the development of pediatric and rare disease drugs...
May 13, 2022
MAH Marketing Approval Priority Review and Approval Innovative Drug Generic Drug Biological Product Cancer Drug Registration New DrugMonthly Report: New Drug Approvals in China | April 2022 In April 2022, China NMPA approved 23 new drugs, including 20 chemical drugs and 3 biological products.
May 12, 2022