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INSIGHTS Generic Drug Application (ANDA) in China
INSIGHTS How to Sell OTC Drugs to China Through Cross-Border E-Commerce
INSIGHTS Drug Application Fees for FY 2022 in China and the U.S.
NEWS China NMPA Announces Key Points for Pharmacovigilance Inspections
INSIGHTS FAQ on Rare Disease Drugs (Orphan Drugs) in China
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
REGULATION
Law & Regulation
China to Renew Medical Sodium Hyaluronate's Administrative Classifications China is going to renew the administrative classifications of medical sodium hyaluronate products according to their intended uses and mechanisms of action.
May 27, 2022
REGULATION
Law & Regulation CDE Guideline Clinical Trial Post-market Cancer GCP
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
REGULATION
Law & Regulation Pharmacovigilance Post-market
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
REGULATION
Law & Regulation Pharmacopoeia
China Issues Corrigenda for the Chinese Pharmacopoeia (ChP) 2020 Chinese Pharmacopoeia Commission corrects the chemical structure depiction of the impurity C18H21N3O2S in Raberazole Sodium.
May 16, 2022
REGULATION
Law & Regulation MAH Pharmacovigilance Marketing Approval Priority Review and Approval Medical Insurance Innovative Drug Generic Drug Rare Disease Drug Registration New Drug
China 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
INDUSTRY
MAH Marketing Approval Priority Review and Approval Innovative Drug Generic Drug Biological Product Cancer Drug Registration New Drug
Monthly 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
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Latest Insights VIEW MORE >
Generic Drug Application (ANDA) in China
FAQ on Rare Disease Drugs (Orphan Drugs) in China
How to Sell OTC Drugs to China Through Cross-Border E-Commerce
Drug Application Fees for FY 2022 in China and the U.S.