The Evolution of CNDA Regulations:

Get Ready for 2019 Compliance

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On July 27, the Chinese National Drug Administration (CNDA) released supplemental guidance (No. 50) on IND clinical trial procedure that brings both challenges and opportunities. The MAH can initiate clinical trial 60-days after submitting IND package without CDE questions, but CNDA requests much stricter risk management to protect the subject. This includes risk benefit assessment, risk control plan, SUSAR reporting, DSUR, Drug Safety Committee and pharmacovigilance system. The introduction of ICH E2B(R3) requirement has pushed the local Chinese pharmaceutical market to scramble.  There might be breathing room now with the update to accept E2B(R2) submissions for another year, but the clock is ticking.

Innovative solutions for the pharmaceutical industry are necessary to meet the CNDA regulation for pharmacovigilance and clinical safety, along with full compliance with E2B(R3) guidelines with complete localization.  Forward thinking Chinese organizations are looking to future proof their PV solutions, while maintaining continuous compliance.

By adopting newer technologies that incorporate machine learning and artificial intelligence, systems can be future-proofed and meet the challenges head-on. This webinar will look at the impact of the latest CNDA announcement on Risk Control Plan, DSUR, ICSR reporting as well as existing and expected submissions.

This webinar will:

  • Address the latest CNDA regulations announcement and the impact on domestic and global companies
  • Explain the requirements on Risk Control Plan, DSUR, SUSAR, Pharmacovigilance System, Drug Safety Committee
  • Explore what is required to be compliant with the latest regulations
  • Provide a ‘first hand’ view into what a compliant, AI driven product can do – in localize language
  • Discuss cognitive computing technologies available