October 2019 Slide of the Month

  • Regulatory reliance should be considered by NRAs regardless of their resource or capacity level and independent of their maturity
  • Regulatory reliance should result in a reduction of regulatory burden and offer an opportunity for faster and more predictable approvals.
  • The timeline from reference country approval to submission of dossiers in a reliance-based regulatory procedure should be flexible.

Definition

Reliance: act whereby a regulatory authority in one jurisdiction may take into account/give significant weight to work performed by another regulator or other trusted institution in reaching its own decision.

References

  1. Report: Facilitating the review of new medicines through risk-based evaluations; Brazil, 2017. http://www.cirsci.org/wp-content/uploads/2018/01/CIRS-March-2017-Workshop-Report_August-2017.pdf
  2. Report: Practical implementation of reliance models; South Africa, 2018. . http://www.cirsci.org/wp-content/uploads/2019/05/CIRS-March-2018-Workshop-report_15March18U15884.pdf

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