The resources below were developed by the Interpretations of Guidances & Regulations Initiative as part of their mission to share expertise to more efficiently and effectively meet the intent of ambiguous regulatory requirements and guidances in both the pharmacovigilance and clinical areas.

Clinical

Accepting Feedback: Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2): Quality Tolerance Limits

Guidance: Integrated Addendum TO ICH E6(R1): Guideline for Good Clinical Practice E6(R2)
Agency: ICH
Guidance Date: November 2016

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Assets
Title Description
Quality Tolerance Limits Framework The Interpretation of Guidance & Regulations Initiative is currently considering how to provide greater clarity on the interpretation and operationalize of Quality Tolerance Limits (QTLs) in a way that meets Health Authority expectations, facilitates efficiency, and minimizes confusion. The initiative has developed a draft QTL Framework intended to aid industry’s ability to improve the quality of Clinical Research through the implementation of QTLs. Included in this Framework are proposed approaches for an end-to-end process for implementing QTLs for a clinical trial as defined in Section 5.0.4 and 5.0.7 ICH E6 R2 and considerations for setting QTL thresholds.
Quality Tolerance Limits Plan Template This template will allow a company to document a QTL Monitoring Plan at the study level. Specifically, the template provides the ability to capture the QTLs, how they will be monitored, document any changes to QTLs throughout the study and any justification for those changes.

We invite industry comments on this draft between September 3 and 19th. The QTL Framework and template can be accessed through the link above. Please submit feedback on or before September 19th using the Submit Feedback button below or email us at feedback@transceleratebiopharmainc.com.

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Pharmacovigilance

FDA’s Postmarketing Safety Reporting for Combination Products Draft Guidance for Industry & FDA Staff

Guidance: Postmarketing Safety Reporting for Combination Products Draft Guidance for Industry & FDA Staff

Agency: FDA

Guidance Date: March 2018

Assets
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.
Clinical Trials Facilitation and Coordination Group Q&A Document - Reference Safety Information

Guidance: CTFG Q&A Document – Reference Safety Information (Nov 2017)

Agency: EMA

Q&A Date: November 2017

Assets
Title Description
Clinical Trials: Global Pharmacovigilance Regulations: Call for Re-harmonization 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.
FDA’s Draft Guidance for Industry Safety Assessment for IND Safety Reporting

Guidance: Draft Guidance for Industry Safety Assessment for IND Safety Reporting (Dec 2015)

Agency: FDA

Guidance Date: December 2015

Assets
Coming soon!
Safety Issue Notification Guidances & Regulations (Australia, Canada, Israel, New Zealand, Saudi Arabia, Switzerland, Turkey)

Guidance: Multiple

Agency: Multiple

Guidance Date: Multiple

Assets
Coming soon!