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GMP News

ICH E11A: Final version published

In August, the final guideline “ICH E11A Guideline on pediatric extrapolation” was published on the ICH website in the “efficacy guidelines” section. It is seen as a supplement to the guideline “ADDENDUM TO ICH E11: CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE PEDIATRIC POPULATION E11 (R1)” and is due to come into force in January 2025.

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FDA's final Q&A Document on Electronic Systems & Data in Clinical Trials

Following the draft paper issued in 2023 the FDA now published the final version of the Question and Answers (Q&A) document on Electronic Systems, Records, and Signatures in Clinical Investigations.

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EMA Guideline on Quality and Equivalence of Topical Products

The European Medicines Agency (EMA) has published a new guideline on the quality and equivalence of locally applied, locally acting cutaneous products.

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