Background:
The Interpretation of Pharmacovigilance Guidances & Regulations Initiative shares expertise to more efficiently and effectively meet the intent of ambiguous regulations/guidances and Health Authority 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.
Topics:
Guidance: See list of guidances considered in “A Framework on the Presentation of Safety Risks Throughout the Product Lifecycle” below.
Agency: Multiple
Date: Multiple
Approach:
- The topic team reviewed definitions of risks in key guidances (GVP and ICH).
- The topic team then provided clarity through a Framework that describes how to present risks in key safety documents throughout the product lifecycle in a manner that complies with the relevant guidances.
Value:
This topic’s objective was to support the presentation of risk information in accordance with Health Authority expectations, through developing a Framework that maps out regulatory requirements and operational considerations for presenting risks at the various product lifecycle stages.
Deliverables:
| Asset Type | Title | Description |
|---|---|---|
 | A Framework on the Presentation of Safety Risks Throughout the Product Lifecycle | A Framework including a comparison of requirements for presentation of risks across the guidelines and phases of the product lifecycle, along with operational considerations on how to present risks in key regulatory/safety documents. |
 | Presentation of Risks Overview Video | An introduction and high level overview of what can be found in “A Framework on the Presentation of Safety Risks Throughout the Product Lifecycle.” |
This topic’s objective was to support patient safety commitments by identifying various approaches to meet Health Authority expectations for safety issue notifications in an effective and efficient manner.
Guidance: See a list of guidances considered in the Safety Issue Notification Guide below
Agency: Australian Therapeutic Goods Administration, Health Canada, Ministry of Health New Zealand, Risk Management and Drug Information Department (Israel), Saudi Food and Drug Administration, SwissMedic, and Turkish Ministry of Health
Guidance Date: See a list of dates for the guidance considered in the Safety Issue Notification Guide below
Deliverables:
| Asset Type | Title | Description |
|---|---|---|
| Safety Issue Notification Guide | A guide to aide understanding of safety issue notification guidances for in-scope countries. |
| Webinar: Safety Issue Notification Guide | A webinar presentation where TransCelerate team members provide an overview of the Safety Issue Notification Guide. |
This topic is intended to enhance patient safety by facilitating adherence to unclear regulatory guidance calling for applicants to take a more holistic view of combination products.
Guidance: Postmarketing Safety for Combination Products Draft Guidance for Industry & FDA Staff
Agency: FDA
Guidance Date: March 2018
Deliverables:
| Asset Type | Title | Description |
|---|---|---|
| FDA Post Marketing Safety Reporting for Drug-Device Combinations Implementation Guide | An Implementation Guide to aide pharmaceutical manufacturers’ understanding of ambiguous areas of the PMSR for Combination Products Draft Guidance for Industry and FDA Staff (March 2018). |
| FDA Post Marketing Safety Reporting for Drug-Device Combinations Implementation Guide: Webinar | A webinar presentation where TransCelerate team members provide an overview of the FDA Post Marketing Safety Reporting for Drug-Device Combinations Implementation Guide. |
This topic’s objective was to interpret ambiguous portions of Reference Safety Information Guidance Q&A, engage with regulators and share findings on implementation challenges and approaches.
Guidance: CTFG Q&A Document – Reference Safety Information (Nov. 2017)
Agency: EMA
Q&A Date: November 2017
Deliverables:
| Asset Type | Title | Description |
|---|---|---|
| Call for Reharmonization: Clinical Trials: Global Pharmacovigilance Regulations | To meet these goals, we at TransCelerate implore representatives for regulatory authorities to work with industry sponsors, in the spirit of ICH, to identify potential ways to re-harmonize global pharmacovigilance processes and requirements. |
| Publication on the Evolving Remit of the Reference Safety Information: Observations on Implementation of the 2017 Clinical Trials Facilitation Group (CTFG) Question & Answer Document | This manuscript highlights industry challenges in operationalizing the requirements of the 2017 Clinical Trial Facilitation Group (CTFG) Question & Answer document. Surveys reveal actions taken in the creation, submission and implementation of the Reference Safety Information (RSI) to meet the requirements of the CTFG and EU national competent authorities whilst staying compliant with global regulatory requirements. |
This topic’s objective was to interpret ambiguous portions of the draft guidance, engage with regulators, and share findings on implementation challenges and approaches.
Guidance: Draft Guidance for Industry: Safety Assessment for IND Safety Reporting (Dec. 2015)
Agency: FDA
Guidance Date: December 2015
Deliverables:
| Asset Type | Title | Description |
|---|---|---|
| Publication on TransCelerate Experience with FDA’s 2015 Safety Assessment Guidance | In this publication, TransCelerate member companies summarize their experience in operationalizing FDA’s clinical trial monitoring and reporting requirements with a key focus on FDA’s Draft 2015 Safety Assessment Guidance. |