Japan Moves To Mandate Barcodes For Drug Traceability

Last week, the Japan Diet, the bicameral legislature, enacted a bill that amends the Pharmaceuticals and Medical Devices (PMD) Law there. From the limited information I have seen from GS1 Healthcare and from online articles I found through Google, it appears that one of the many things the new bill does is add a new barcoding mandate.  Previously, barcoding of medicines and medical devices in Japan was only recommended.

I have become familiar with the workings of Google Translate to convert native language bills, regulation and guidance from several countries into English text so I can understand the general ideas and deadlines contained in them.  GS1 Healthcare provided several actual documents from the government of Japan but Japanese is apparently a little beyond the capabilities of that automated translator.  I was able to get some English text by pulling a few tricks I’ve learned, but it isn’t really usable.  So we have to rely on articles from online journals that monitor the Japan government.

I found several articles on Pharma Japan‘s website about the new bill.  You can sign up for a free two week trial subscription here, which is what I did so I could read them.  The articles include “Amended PMD Law Set for 3-Step Enforcement, 1st Execution Eyed Next Autumn” and “Amended PMD Law Promulgated, 3-Step Enforcement to Begin Next Year”.  Don’t be scared by the titles of these articles because the first deadline is for things not related to serialization and traceability.  According to that last article, the bill “…will make mandatory barcode labeling on the immediate container, wrapper, and packaging of drugs, medical devices, and regenerative medicine products to improve traceability.”  That requirement will take effect no more than three years after its announcement in the official gazette.

What I can’t figure out from any of the information I have seen is whether or not the new mandate will require serialization.  The new barcoding requirement is clearly intended to improve traceability.  Normally, that would mean serialization, but that’s not guaranteed.  I assume the details are being left up to the Ministry of Health, Labor and Welfare (MHLW).  In that case, we’ll certainly see new regulations published by that department in the next year…hopefully less.

As far as I can tell, the mandate contained in the law is simply for barcode labeling “…to improve traceability”, but does not mandate actual traceability.  But since I can’t read the bill that was enacted, I can’t be sure.

If we assume the bill will be published in the official gazette this month, then the deadline for barcodes for traceability on drugs, medical devices and regenerative medicine products will be in December of 2022 or earlier.  Let me know if you understand differently.

Dirk.

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