Historically, there have been challenges addressing ambiguous regulations/guidances and operational expectations. Specific challenges have included one or more of the following elements:

  • Substantive ambiguities in text of regulation/guidance, which may result in, among other things, difficulties in interpreting and adhering to regulations/guidances
  • Divergence in regulatory requirements and expectations across global Health Authorities
  • Real world impediments to operationalizing Health Authority expectations

The Interpretation of Guidances & Regulations Initiative will share expertise to more efficiently and effectively meet the intent of ambiguous regulations/guidances and operational expectations around the world. Secondarily, the initiative will take opportunities to raise Health Authority awareness of the real-life impact of ambiguous regulations/ guidelines. While addressing these aims, the initiative will consider the highest priority to be the continued enhancement of patient safety.


Addressing these challenges will bring value to patients, sponsors, and regulators. Examples of value include:

  • Enhanced patient outcomes/safety through a better understanding and exploration of operational best practices to meet ambiguous regulations/guidances
  • Reduced sponsor inspection and compliance risks through better understanding of regulations/guidances
  • Increased effectiveness and efficiencies in meeting the operational expectations of ambiguous regulations/guidances
  • Clarification of ambiguous regulations/guidances through proactive sharing of feedback, observations, consequences, recommendations and best practices with Health Authorities

Available Assets

This initiative explores various guidances and the following reflect our current focus:

  • IND Safety Reporting Regulations: Interpret ambiguous portions of draft guidance, engage with regulators, and share findings on implementation challenges and approaches
  • Reference Safety Information: Interpret ambiguous portions of RSI Guidance Q&A; engage with regulators, share findings on implementation challenges, approaches, and regulator feedback
  • PMSR for Drug-Device Combinations: Enhance patient safety by facilitating adherence to unclear regulatory guidance calling for a more holistic view of combination products
  • Safety Issue Notifications (Australia, Canada, Israel, New Zealand, Saudi Arabia, Switzerland & Turkey): Support patient safety commitments by identifying various approaches to meet Health Authority expectations for safety issue notifications in an effective and efficient manner
  • Quality Tolerance Limits: Improve the systemic quality of CR through the implementation of QTLs in a way that facilitates compliance, efficiency and minimizes confusion and duplication of effort

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