Japan PMDA definition

Japan PMDA means Japan’s Pharmaceuticals and Medical Devices Agency and any successor agency or authority having substantially the same function.
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Japan PMDA means the Japanese Pharmaceuticals and Medical Devices Agency and any successor agency thereto.
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Examples of Japan PMDA in a sentence

  • In addition, there is the possibility that this study may be inspected by regulatory agencies, including those of foreign governments (eg, the Food and Drug Administration [FDA], the United Kingdom Medicines and Healthcare products Regulatory Agency [MHRA], the Pharmaceuticals and Medical Devices Agency of Japan [PMDA]).

  • Study data from the Japanese centers will not be included in the PMA-S submission but will be made available.A final report will be submitted to Japan PMDA at the completion of the last 12 month visit from the 15 treated Japanese subjects.

  • In addition, there is the possibility that this study may be inspected by regulatory agencies, including those of foreign governments (eg, the FDA, the United Kingdom Medicines and Healthcare products Regulatory Agency [MHRA], the Pharmaceuticals and Medical Devices Agency of Japan [PMDA]).

  • The manufacturing location at Roorkee, Uttarakhand with 5 acres of infrastructure is USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA audited and approved.

  • At the completion the last 12 month visit from the enrolled and treated Japan subjects, a report will be submitted to Japan PMDA.

  • In September 2017, Kyorin submitted a marketing application for vibegron to the Japan PMDA.

  • In addition, there is the possibility that this study may be inspected by regulatory agencies, including those of foreign governments (eg, the Food and Drug Administration [FDA], the United Kingdom Medicines and Healthcare products Regulatory Agency [MHRA], Pharmaceuticals and Medical Devices Agency of Japan [PMDA]).

  • A final report will be submitted to Japan PMDA at the completion of the study.

  • The company is market leader in four APIs and is amongst the top 3 players for another three APIs in its portfolio helping it to maintain a high contribution margin.The dosage formulations manufacturing location at Roorkee, Uttarakhand, with 5 acres of infrastructure, is USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISAaudited and approved.

  • As claimed that, Novaferon also registered in the name of M/s Genova Biotech (Qingdao) Co. Ltd., China then kindly provide its registrationcertificate, both form Japan PMDA & China.

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