MHLW issues Japanese Pharmaceutical Excipients 2026, with a 2028 deadline

MHLW's Pharmaceutical Bureau issued the official standard for excipients that are not listed in the Japanese Pharmacopoeia as the Japanese Pharmaceutical Excipients 2026 on October 30, 2026, in Notification No. 1030-5. The attachment carries the standard itself and gives its English name as Japanese Pharmaceutical Excipients 2026, abbreviated JPE2026. It is the first full revision since the 2018 edition, which is abolished as this notification applies. Items already approved may follow the previous standards until March 31, 2028, and from April 1, 2028 the JPE2026 standards apply.

The notification lists 91 revised monographs, the preface 88

The general tests gained one item, a phosphate buffer solution, and nine reference standards and eight reagents and test solutions were revised. For the monographs, the summary in the notification lists 91 items whose specifications were revised, and the edition holds 487 items in all. The preface to the attachment gives the number of partially revised items as 88, so the two counts do not agree.

The items listed in the notification include aspartame, sucralose, hydrated silicon dioxide, polysorbate 20 and 60, and methacrylic acid copolymer L, LD and S. Where an existing notification or similar document refers to the Japanese Pharmaceutical Excipients, that reference is now to the new edition.

Approved items may follow the previous standards until March 31, 2028

For a drug or quasi-drug already approved whose ingredient specification is the Japanese Pharmaceutical Excipients, the previous standards may be followed until March 31, 2028, and from April 1, 2028 the JPE2026 standards apply (Notification No. 1030-1, item 1(2)). An item approved with the wording that the specification is according to the Japanese Pharmaceutical Excipients may likewise be treated as following the pre-revision standard until the same date (item 2). Past the deadline, the wording in the approval can stay as it is while the standard it points to is replaced.

Keeping the old specification takes a minor change notification

To keep a pre-revision specification from April 1, 2028, the marketing authorization holder files a minor change notification that moves the specification to an attached specification, with the specifications and test methods set to the content of the pre-revision Japanese Pharmaceutical Excipients. That notification is due by March 31, 2028, and its remarks column states that the filing is made under this notification (item 4).

A new application that sets the specification to JPE2026 writes "JPE" in the column for ingredients and quantities, or essence, and omits the specification content (item 1(1)). Until March 31, 2028 the same omission is acceptable for an application that uses the pre-revision specification.

For OTC drugs and quasi-drugs, elemental impurities go to JP General Notices 33

For drugs requiring guidance, over-the-counter drugs and quasi-drugs, where a preparation is not subject to elemental impurity control and uses an excipient that has a JPE monograph, control follows in principle General Notices 33 of the Japanese Pharmacopoeia, applied through General Notices 2 of JPE2026 (item 3(1)). Where the marketing authorization holder can assure that the requirement of General Notices 33 is met, an additional heavy metals test and individual metal impurity test are not needed, and no regulatory procedure is required.

The paperwork remains. The holder has to prepare a document confirming that the requirement is met, and be able to explain the state of that control. Where compliance cannot be confirmed and the drug product manufacturing site runs both tests, the remarks box of the specifications and test methods column states that the heavy metals specification test and individual metal specification test based on the monographs of the Japanese Pharmaceutical Excipients 2018 will be performed, and a new application or a minor change notification is filed (second paragraph of item 3(1)). A holder filing the minor change notification described above does not need this second one (item 4(2)).

What to settle before April 1, 2028

Start from the monographs. Check whether an excipient in your product is among the items the notification lists, and if it is, which test items and specification values in its monograph were revised. Where a test method changed, the specification items in incoming testing and in the supplier's certificate of analysis have to be lined up with it again. An excipient listed in the Japanese Pharmacopoeia is not listed in the Japanese Pharmaceutical Excipients, so which of the two standards covers your material is the first thing to confirm.

On the approval side, list the items whose approval says JPE, or says that the specification is according to the Japanese Pharmaceutical Excipients, and decide by March 31, 2028 whether to keep the pre-revision specification or move to the new one. The filing sits with the marketing authorization holder in Japan, so for a supplier outside Japan the question that comes back is which text each lot is tested to, and from which date.