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GMP News

EMA Reflection Paper on Safety Signals for Herbal Medicinal Products

The European Medicines Agency (EMA) recently published a draft Reflection paper on particulars for safety signals for (traditional) herbal medicinal products (HMPs). The deadline for comments is 15 October 2026.

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EMA publishes Consolidated ICH E6(R3) Guideline

The European Medicines Agency (EMA) published a consolidated version of the ICH E6(R3) Guideline. The ICH E6(R3) guideline builds on key concepts outlined in ICH E8(R1) Revision of General Considerations for Clinical Studies.

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FDA announces new Draft Guidance on Container Closure Systems

In its new draft guidance, the FDA proposes a risk-based framework for the evaluation of container closure systems. It highlights the growing importance of innovative materials and extractables and leachables. The draft is now available for review, and comments may be submitted until 13 October 2026.

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