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Frequently Asked Questions

When will the PMDA start accepting electronic data submissions?

The PMDA will start accepting electronic data submissions via its gateway system from 1 October 2016. The eCTD version 4.0 will be accepted from 1 April 2020 and will be mandatory from April 2022.

Where can I find the PMDA confidentiality policy?

It should be published and/or posted on the PMDA website so that the foreign manufactures would be able to understand the PMDA confidentiality policy. The provisions concerning confidentiality obligations are prescribed under the Articles 13 and 42 in Act on Pharmaceuticals and Medical Devices Agency, Independent Administrative Agency.

Can pmpmda provide a list of marketing authorization holders?

PMDA is NOT able to provide specific information such as a list of Marketing Authorization Holders. For your information, we only provide a link page including Japan's pharmaceutical and medical device manufacture association which Japanese Marketing Authorization holders belong to at.

Does PMDA accept applications in other languages?

No, PMDA does not accept applications in other languages. Japan's Pharmaceutical Affairs Law requires all forms related to the marketing application to be submitted in Japanese. What is the classification for application of the product in Japan (Pharmaceuticals, Quasi-drugs, Cosmetics, Medical devices, etc.)?

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