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.

JP Drafts (September 2026) Part 2

The package includes:

• 16 new monographs,
• 3 new monographs for natural drugs,
• 3 ultraviolet-visible reference spectra
• 4 infrared reference spectra.

Comments can be submitted from 1 September to 30 November 2026. For the full list of drafts, the comment form and submission instructions, please visit the PMDA website.

JP Drafts (September 2026) Part 1

The first set of JP drafts for September 2026 with a public comment period running from 1 to 30 September 2026, is also still available. It contains three new General Information drafts:

• Concept on the Assessment and Control of DNA Reactive (Mutagenic) Impurities in Chemically Synthesized Drug Substances and Drug Products<G0-7-191>
• Nitrogen Determination: Combustion Method (Modified Dumas Method)<G1-11-191>
• Possible Amendments of the Scientific Names of Natural Drugs listed in the JP<G5-10-191>