Japan Revises the Requirements for Quasi-drugs

On March 27, 2023, MHLW issued Notification 0327 No. 1 and Notification 0327 No. 5, including minor adjustments to reagents and test solutions in Japanese Standards of Quasi-drug Ingredients 2021 (hereinafter the "JSQI 2021") and revision to the application for manufacturing and sales license. These amendments came into effect upon its publication on March 27, but the previous provisions can still be applied before September 30, 2024.

Reagents and test solutions

According to the Notification 0327 No. 1, the names of reagents in JSQI 2021 have been made consistent with the names in other regulations such as the Japanese Pharmacopoeia. Besides, the method of describing reagents, test solutions, etc. has been unified. The specific involved contents in JSQI 2021 are:

1. General test method 

(1) 39．Water Determination (Karl Fischer Method)

(2) 40．Water-soluble Collagen Testing Method

(3) 80．Standard

(4) 81．Reagent and test solution

(5) 82．Standard solution for volumetric analysis

(6) 83．Standard solution

2.  Quasi-drug ingredients

(1) Tallow Fatty Acid

(2) Cyclodextrin Sugar Alcohol Mixture

(3) Deoxyribonucleic Acid

(4) Calcium Phosphate Hydroxide

(5) Disodium Riboflavin 5′-Adenosine Diphosphate Dihydrate

(6) Jojoba Alcohol

(7) Poly N,N-Dimethyl-3,4-Dimethylene-Pyrrolidinium Chloride Solution

(8) Linalool

(9) Ribonucleic Acid (1)

Manufacturing and sales license

On the same day, MHLW immediately issued Notification 0327 No. 5 to modify the application requirements for the manufacturing and sales license of quasi-drugs.

• Until September 30, 2024, it is still permissible to apply for approval based on the pre-revised standards for quasi-drugs containing the above-involved ingredients whose application for approval is newly submitted. After that, stakeholders shall fill "Revised Japanese Standards of Quasi-drug Ingredients ('改正外原規' in Japanese)" in the "Ingredient and Content" column of the application form.

• When quasi-drugs containing the above-involved ingredients but that have already been approved, the application or license will be valid until the end of September, 2024.

For quasi-drugs that have already been approved, but the names of reagents and/or test solutions have been modified along with this revision, there is no need to apply for a "complete change application" or a "minor change application" for only changing the name. Stakeholders can apply for the change together when other kinds of changes subject to application happen.

Notably, minor change applications submitted before September 30, 2024, need to be stated "The application is made on the basis of the Notification 0327 No. 5 issued by Japan MHLW on the partial revisions to the Japanese Standards of Quasi-drug Ingredients 2021" in the application form.