A Review of China's Life Science and Healthcare Sector 2021: Embracing a Dynamic Regulatory Landscape

January 09, 2022 | BY

Susan Mok

Ting Wu of Haiwen & Partners reviews the regulatory reforms taking place in China's life science and healthcare sector including legislation that has been released to encourage innovation and broaden market access to drugs, implementation of the patent linkage system, increasing antitrust enforcement pressure in the pharma sector, regulating medical devices, cosmetics and online hospitals.

 

Summary

  • The Chinese government has been taking a series of reform initiatives to enhance the affordability of pharmaceutical products, medical devices and healthcare services.
  • NMPA released the first Good Pharmacovigilance Practice(GVP) which means that sponsors or market authorization holders (MAH) are required to conduct pharmacovigilance activities throughout the entire lifecycle of a pharmaceutical product.
  • Under the Good Pharmacovigilance Practice, pharma companies must proactively monitor and detect all indicators related to drug safety and robustly address and mitigate any identified risks.

 

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