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
Implementation Experience
As solutions are used throughout the R&D ecosystem, TransCelerate receives feedback related to solution implementation experiences. Anyone can submit an experience through the Engage with Us page and in select cases, we share the experiences on Our Impact page in a blinded way. Below is a featured example for this initiative:
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- FDA’s Draft Guidance for Industry: Safety Assessment for IND Safety Reporting
- FDA’s Postmarketing Safety Reporting for Combination Products Draft Guidance for Industry & FDA Staff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
- Regulations Governing the Use of Medicines in Pregnancy & Breastfeeding