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Spotlight on regulatory reforms in China


Download our whitepaper to learn how our Regulatory Affairs teams can help sponsors navigate through the regulatory challenges, bridge communication with the CDE, and develop successful regulatory strategies.

China’s regulatory reforms have attracted many foreign companies to conduct clinical trials and register their medicinal products in China. Changes to the new framework include expedited regulatory pathways, optimised review and approval processes for clinical trial applications (CTAs) and marketing authorisation applications (MAAs), full implementation of the Marketing Authorization Holder (MAH) system, and new regulatory guidelines. This evolving regulatory environment and country-specific requirements present significant challenges.

In this paper, learn about:

  • Important changes to the Drug Administration Law and the New Provisions for Drug Registration impacting sponsors.
  • Communication and consultation strategies for interactions with the Center for Drug Evaluation (CDE).
  • Expedited regulatory pathways and handling post-approval changes.