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