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GMP News

The Relationship between the BP and the Ph. Eur.

The British Pharmacopoeia (BP) has published a new “Key Insights” article explaining the relationship between the British Pharmacopoeia (BP) and the European Pharmacopoeia (Ph. Eur.), as well as the UK’s contribution to the development of European pharmacopoeial standards.

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New Japanese Pharmacopoeia Drafts (September 2026) Open for Public Comment

The Pharmaceuticals and Medical Devices Agency (PMDA) has published the second set of Japanese Pharmacopoeia (JP) draft texts for September 2026. The drafts include new monographs, natural drug monographs, and ultraviolet-visible and infrared reference spectra. Comments can be submitted until 30 November 2026.

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EMA publishes final ICH M13B Guideline and Q&A on Bioequivalence

The European Medicines Agency (EMA) has published the final  ICH M13B guideline on bioequivalence for immediate-release solid oral dosage forms - additional strengths biowaiver - Step 5, together with an accompanying Questions and Answers document.

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