PMDA's mission is to help improvement of public health in Japan by three-pillar system that consists of Relief Services for Adverse Health ...

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To faster access to quality assured effective and safety medical products, PMDA is committed to reviewing applications for them in a prompt ...

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This video introduces the classifications of drugs that are reviewed for marketing approval in Japan, and an introduction to the review ...

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(Review) Expedited Regulatory Pathways in Japan - PMDA-ATC Learning Videos ; 11:10 · 738 views ; 5:00 · 629 views ; 13:14 · 194 views ; 28:24 · 205K ...

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This video introduces the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC), and its activities ...

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There is a system in which some of the medical devices and IVDs can be marketed if they are certified of their conformity to the criteria by ...

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This video introduces how PMDA deals with adverse drug reaction and infection reports, and the current regulatory framework for drug ...

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This video introduces Drug Master File system in Japan. The purpose of this file is to protect the intellectual property of the active ...

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10 videosLast updated on Nov 30, 2023. Play all · Shuffle · 7:22. Philosophy - PMDA-ATC E-learning. Pmda Channel.

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8 videosLast updated on Oct 31, 2023. Play all · Shuffle · 7:00. (Medical Device) Medical Device and IVD Regulations - PMDA-ATC E-learning. Pmda Channel.

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This video introduces the categories of drug application and the necessary documents for applicants to submit for regulatory approval of ...

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... SaMD. (Medical Device) Regulatory Approach to Software as a Medical Device in Japan. 48 views · 5 days ago ...more. Pmda Channel. 4.27K.

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Need a local team of regulatory affairs professionals who can help you register your medical device with PMDA? GRP- Japan is Located in ...

YouTube-Global Regulatory Partners Inc.

PMDA has been participating in international committees to promote the regulatory harmonization. This video introduces outline including the ...

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This video introduces the outline of the Japanese Pharmacopoeia (JP). PMDA is involved in the development of draft monographs and general ...

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This video introduces the difference between new drugs and generic drugs in the life cycle, the data that are reviewed for approval of ...

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This video introduces the standard review process of a new drug application and some of the related services provided by PMDA.

YouTube-Pmda Channel

Pmda Channel · 6:00. (Review) Why MRCT? - PMDA-ATC E-learning. Pmda Channel · 4:13 · (Review) Orphan Drug Designation System in Japan - PMDA-ATC Learning Videos.

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Risk minimization activity is aiming to inform and update safety information effectively to health care professionals and patients as risk ...

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