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GMP News

ICH E20 Draft Guideline on Adaptive Design for Clinical Trials

The ICH E20 draft Guideline on “Adaptive Design for Clinical Trials” has reached Step 2b of the ICH Process and entered the Step 3 public consultation period. The EU deadline for comments is 30 November 2025.

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Update on ICH Guidelines E21 & E22

The ICH is currently working on two new Efficacy Guidelines: E21 on Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials and E22 on General Considerations for Patient Preference Studies.

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Glass Containers for Pharmaceutical Use

A revised version of Ph. Eur. chapter 3.2.1. Glass containers for pharmaceutical use has been published in Pharmeuropa 37.3. The comment deadline is 30 September 2025.

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