Convergence of Local & Global Pharmacovigilance Regulations in China for Drug Manufacturers -

Achieving compliance through LifeSphere Safety MultiVigilance

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With the recent string of regulatory reforms and NMPA joining ICH, China is poised to catch-up with the leading health authorities in bringing high-quality, low-cost, innovative medicines to its population and ensuring safe and effective use of medicinal products.

This white paper provides an overview of pharmacovigilance in China and recent regulatory reforms made to achieve standards on par with leading health authorities.

A closer examination is provided on the following topics:

  • A brief history of pharmacovigilance in China
  • Current pharmacovigilance process
  • Adoption of new ICH guidelines and the impact on current practices
  • How ArisGlobal supports new safety reporting standards in China