Rationale
Historically, there have been challenges addressing ambiguous regulations/guidances and Health Authority 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, challenges in interpreting regulations/guidances
- Divergence in regulatory requirements and expectations across global Health Authorities
- Real world impediments to operationalizing Health Authority expectations
Benefits
Addressing these challenges will bring value to patients, sponsors and regulators. Examples of this value include:
- Patients: Enhanced patient outcomes/safety through a better understanding and exploration of operational best practices to meet ambiguous regulations/guidances
- Regulators: Clarification of ambiguous regulations/guidances through proactive sharing of feedback, observations, consequences, and proposed best practices with Health Authorities
- Sponsors: Reduced compliance risks through better understanding of regulations/guidances
- Sponsors: Increased effectiveness and efficiencies in meeting the operational expectations of ambiguous regulations/guidances
Available Solutions
The initiative has or is addressing the following ambiguous pharmacovigilance regulations and guidances:
- Clinical Trial Facilitation and Coordination Group Q&A Document: Reference Safety Information
- FDA’s Draft Guidance for Industry: Safety Assessment for IND Safety Reporting
- FDA’s Postmarketing Safety Reporting for Combination Products Draft Guidance for Industry & FDA Staff
- Safety Reporting Safety Issue Notification Guidances & Regulations (Australia, Canada, Israel, New Zealand, Saudi Arabia, Switzerland, Turkey)
- Presentation of Safety Risks Throughout the Product Lifecycle – asset coming soon!