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GMP News

WHO: TRS 1060 regulatory Guidelines published

In April 2025, the WHO published annexes to its current Technical Report Series (TRS) 1060 on its website, including 'Annex 7: Good practices of national regulatory authorities in implementing the collaborative registration procedures for medical products' and 'Annex 8: Collaborative registration procedure between WHO and national regulatory authorities in the assessment and accelerated national registration of WHO-prequalified vector control products'.

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Survey Results: The Use of DoE in the Pharmaceutical Industry - Part I

Design of Experiments (DoE) is mentioned as a method in various ICH guidelines and in a chapter on the European Pharmacopoeia. Is DoE already being used in the pharmaceutical industry and in the manufacture of active pharmaceutical ingredients? The ECA wanted to evaluate this by means of a survey. Read the results in Part I on the outcome of the survey.

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EMA publishes Overview of Comments received on ICH M13B Guideline on Bioequivalence

On 25 July 2025, the European Medicines Agency (EMA) published an overview of the comments received on the draft version of the new "ICH Guideline M13B on bioequivalence for immediate release solid oral dosage forms - additional strengths - Step 2b".

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