PMDA sets policy for preparing the 20th Japanese Pharmacopoeia
The policy covers future tests and impurity control. PMDA opened consultation on the draft monograph-preparation guide on 30 October; comments close on 30 November.
Japan's Pharmaceuticals and Medical Devices Agency published the basic policy for preparing the 20th Japanese Pharmacopoeia. It identifies possible additions to general tests, international harmonisation, impurity control and cleaner analysis using less sample and solvent.
The policy guides future drafting; it does not by itself change an effective pharmacopoeial requirement. Pharmaceutical laboratories should monitor subsequent draft texts and implementation dates before revising controlled procedures.
Update, 30 October 2026: PMDA published the draft Instructions for Preparing Drafts of the 20th Japanese Pharmacopoeia and invited comments due by 30 November 2026. The guide primarily addresses drug-substance and preparation monographs and applies to general test methods where feasible. It covers the setting of specifications and analytical procedures and supporting materials for monograph proposals. PMDA says its approach will generally also apply to forthcoming partial revisions and supplements of the 19th Japanese Pharmacopoeia. Laboratories preparing proposals can review the draft's expectations for tests, reagent consumption and supporting measurements. The consultation does not itself change any binding method or specification.