Japan Issues Temporary Policy to Speed up the Review Process of Disinfectants

According to the Ministry of Health, Labor and Welfare (MHLW), the spike in demand for disinfectants amid a recent surge in coronavirus infections has gradually drained supplies in Japan. Businesses all over the country are exploring ways to manufacture such products to address shortages.

Given the increasing applications for approval of disinfectants, MHLW introduced interim guidance on April 24 to accelerate the approval procedures of these newly-designated quasi-drugs. Notably, this new policy only serves as an expedient measure in exceptional circumstances, and it will be subject to changes or abolishment when the situation returns to normal.

Specifics of the Temporary Policy

• Competent Authorities

MHLW will cooperate with Pharmaceuticals and Medical Devices Agency (PMDA) to expedite the regulatory procedures for skin disinfectants (designated quasi-drugs).

• Applicable Scope

The “fast-track approval” policy only applies to the application for approval of newly designated skin disinfectants, which comply with the provisions specified in Annex 3 of the Manufacturing (Import) Approval of the Newly Designated Quasi Drugs and have the effect of cleaning and disinfecting fingers and skin.

• Application Procedures and Required Information

Once the disinfectant products are confirmed to be eligible for expedited approval, the following five materials shall be submitted to responsible officials of MHLW to apply for a quick review.

During the data preparation stage, enterprises should notify the responsible officials of the expected approval date in advance. After the approval is obtained, enterprises should within a specific time limit, inform officials of the actual approval date and the system acceptance number. Additionally, in order to complete the examination promptly, enterprises are required to deal with the inquiries and instructions of PMDA as quickly as possible during the review process.