There are two updates proposed in Japanese regulations regarding changes. The first is the substitution of analytical methods and the other concerns post-approval change control. In addition, there seems to be a recent change of attitude by Japan’s PMDA (Pharmaceuticals and Medical Devices Agency).

Substitution of an official analytical method has not been allowed since April 28, 2021 (Notification revision to ordinance on pharmaceutical product and quasi pharmaceutical product manufacturing and quality control standards). It was a surprising requirement and discussions have occurred since then. As a result, substitution of an analytical method is now accepted. However, a necessary partial application is recommended, which is announced by the submission of a substitution of analytical method notification (enacted June 21, 2023). The authorities’ idea is that the application methods must be exactly followed for the manufacturing of pharmaceuticals. Substitution of analytical method refers to the analytical method for specification which is different from the alternative procedures described in ICH Q6A.

The other proposal will be the addition of a medium-level post-approval change application. Currently, Japan has two categories of the post-approval change system. One is the partial application (time clock is either 1 year or 6 months depending on your application format) and the other is the minor change submission. What is now agreed between authorities and industry is to have a medium-level post-approval change application, which is similar to the Changes Being Effected in 30 Days (CBE30) requirement in the US. The expected period for the assessment is 30 working days and if you get the approval, you can initiate the proposed change.

The Japan authority, PMDA has initiated a ‘Round table’ series where industry members and authorities discuss specific issues freely. The first topic was deviation control (Tokyo, Dec 2022), followed by analytical abbreviation (Osaka, Nov 2023) and still to come: manufacturing control (Tokyo, Feb 2024). Registration for attendees is free and authorities are now consulting for better practices here.

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