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

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
Coming soon!

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FDA’s Postmarketing Safety Reporting for Combination Products Draft Guidance for Industry & FDA Staff

Guidance: Postmarketing Safety Reporting for Combination Products Draft Guidance for Industry & FDA Staff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Guide to aide pharmaceutical manufacturers‘ understanding of ambiguous areas of the PMSR for Combination Products Draft Guidance for Industry and FDA Staff (March 2018).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FDA’s Draft Guidance for Industry Safety Assessment for IND Safety Reporting

Guidance: Draft Guidance for Industry Safety Assessment for IND Safety Reporting (Dec 2015)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
Title Description
Safety Issue Notification Guide A guide to aide understanding of safety issue notification guidances for in-scope countries.
Safety Issue Notification Guide Webinar A webinar presentation where TransCelerate team members provide an overview of the Safety Issue Notification Guide.