Tag: ICH Q1E shelf life

Common Reviewer Queries on Expiry Date Justifications

When filing a submission to extend the expiry date of a pharmaceutical product, regulatory reviewers from agencies like the FDA and EMA often raise questions to ensure the shelf life justification is scientifically sound. Addressing these reviewer queries effectively is crucial to avoid delays, RFIs (Requests for Information), or rejection. This guide explains the most…

Regulatory Submissions for Shelf Life Extensions, Shelf Life and Expiry

Extrapolating Shelf Life Using ICH Q1E Recommendations

Regulatory authorities often accept shelf life extrapolation based on well-documented stability data—provided the approach complies with ICH Q1E recommendations. In this article, we provide a detailed, regulatory-focused tutorial on how to extrapolate shelf life using statistical principles outlined by ICH Q1E and accepted by global agencies like the USFDA. ➀ What Is Shelf Life Extrapolation?…

ICH Q1E and Stability Data Evaluation, Protocols and Reports