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Frequently Asked Questions

What is the role of PMDA in the pharmaceutical industry?

Pharmaceuticals and Medical Devices Agency (PMDA) was formed on April 1, 2004 to provide the cGMP pharmaceutical guideline to the nation. Relief services for adverse health effects, GMP inspection of drug manufacturing facilities and post-marketing safety measures are the main services of PMDA.

How does the PMDA process a new drug application?

Applicant submits the New Drug Application (NDA) forms to the PMDA for market approval. The PMDA then reviews the application, and if they feel necessary, may schedule a face-to-face meeting with the applicant.

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.)?

Does pmpmda accept mdsap audit reports?

PMDA has been accepting MDSAP audit reports since 2016. The following chart illustrates the results of the acceptance from 2017 to 2020. Stakeholders in Japan are discussing in order to formalize these acceptance activities.

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