Top 10 BaiPharm Stories of China's Pharmaceutical Regulations | 2021 Recep

by Grace Wang Jan 07, 2022

ChemLinked BaiPharm Portal has been delivering and decoding China's pharmaceutical regulations to help international drug makers access the Chinese market. Here are the 10 regulatory topics that our readers are most concerned about in 2021. 

Top Five News

ChemLinked BaiPharm News delivers new pharmaceutical regulations and market updates in China.

1. China's GVP Takes Effect

China started to implement its Good Pharmacovigilance Practices (GVP) on Dec. 1, 2021. The GVP applies to pharmacovigilance activities, which monitor, identify, evaluate and control adverse drug reactions (ADRs) and other medication-related negative reactions.

The Chinese GVP underlines that MAHs should assume the legal obligation even if pharmacovigilance affairs are entrusted to a third party. 

2. China Waives Tariffs for Importing OTC Drugs via a Pilot E-commerce Program

In May 2021, China's State Council granted a pilot program for retailing imported drugs in Henan Province through cross-border e-commerce. The program sets the tentative tariff rate at zero for 13 over-the-counter (OTC) drugs approved by China NMPA.

The pilot program operates in a mechanism through which hospitals, pharmacies, and patients can directly purchase overseas drugs. [Catalog of OTC Drugs in China]

Mechanism for Retailing Imported Drugs in Henan Province via the Cross-Border E-commerce Pilot Program

3. China Cracks Down on Monopolies in Active Pharmaceutical Ingredient Industry

Grace Wang
ChemLinked Regulatory Analyst
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