PMDA Act, Nov 2014 revisions - source in English?



Hi, folks. So glad to see Elsmar Cove back.

I am looking for an English translation of the “Act on Securing Quality Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy products, Gene Therapy Products, and Cosmetics” (usually referred to as the "PMDA Act") that went into effect on 25 November 2014.

Unfortunately, Japan's PMDA is no help:

Does PMDA provide or recommend any publications in English to learn about Japan's drug and medical device regulations?

As PMDA, an independent administrative institution, shall maintain a neutral and impartial position, we can not recommend any particular company or publication. We only provide the information related to government document including the Pharmaceutical Affairs Law, announcements and notifications issued from MHLW. There are some publications of Japanese regulations and books for licensing procedures which are translated into English. So please contact the publishers directly and/or use some internet book search services to seek your information."

(Source: PMDA; as this is my first post, I am not actually allowed to submit a link yet.)

I have looked pretty hard and found nothing but white papers and presentations; these are helpful, but surely by now someone is offering a translation for sale?

What am I missing?


Thank you very much for this! This appears to be exactly what I was looking for.

All best.
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