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Timeline For EU GMP Annex 1 Revision Remains Unclear

Executive Summary

Annex 1 update: A pharmaceutical industry insider says that while Brexit has slowed the work of EMA guidance development, exceptions are Annex 1 and Annex 21, which are deemed high priority.  Word has it that the controversial PUPSIT requirement has been included in the latest draft, and that the annex's next rapporteur will come from the French national competent authority.

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