Japan: PMDA Issues Guidelines on the Digitalization of Packaging Inserts

ARQon
Jul 8, 2021
1 min read

Digitization of package inserts, which was decided as a result of the revision of the Act on Securing Quality, Efficacy, and Safety of Products Including Pharmaceuticals and Medical Devices (Act No. 145 of 1960; hereinafter referred to as the "PMD Act") in 2019, will be implemented on 1 August 2021.

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has released a guideline outlining the updated package insert digitalization standards. Starting from 1 August 2021, package inserts of all medical devices and IVDs must be posted to the PMDA website, making them viewable through a free smartphone application. For products purchased directly by consumers, paper package inserts will continue to be included.

Communicating the most up-to-date information in paper form has proven challenging since package inserts included in stock products from wholesalers and medical institutions, for example, are not updated with updates to precautions that may be enforced. Hence, with the digital packaging insert, it allows manufacturers to do the updates in a consistent and timely manner, in addition to save on paper inserts.

More info can be found in Digitalization of Packaging Inserts Guidelines and Pharmaceuticals and Medical Devices Safety Information.

Sources:

Digitalisation of Packaging Inserts Guidelines

Pharmaceuticals and Medical Devices Safety Information