Module 19 2021

01/06/2021

The big 5 regulated Markets -Japan

Pharmaceutical and Medical Device Act (PMD Act) ● Pharmaceuticals Affairs Law was revised to PMD Act on 2014/11/25. – The major changing points were; – - To strengthen the regulation from the perspective on safety – - To designate software for medical treatment as medical device – - To set the regulation for regenerative medicine Ministerial ordinance of PMD, Quality Management System(QMS), Good Quality Practice （ GQP), Good Vigilance Practice （ GVP) ● Must comply with QMS, GQP and GVP for all IVD and MD. There are many guidelines, notification under these ordinance

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The big 5 regulated Markets -Japan

Japan has three product classifications: Class III: Approval by MHLW / PMDA ● Products with high risk and a significant effect on human life ● Infectious diseases, Tumor markers, Blood typing/Cell typing, Nucleic acid of pathogen, ● New markers ● Markers beyond the approval criteria ● (These products are examined by the specialists' committee) ● HIV, HCV, HDV, HTLV, NAT, Human genetic test, New markers Class II: Certification by Certification (Notified) Body ● Products with relatively small risk and a smaller effect on human life than Class III products ● Autoimmune, Hormone, Biochemistry, etc. ● If the product doesn't meet the certification criteria, it should be submitted PMDA for approval by MHLW. ● Consumer tests (glucose, total protein and hCG) are classified as Class II. They could be certified as OTC. Class I: Notification (Self-certification) ● Products with small risk and a smaller effect on human life than Class II products ● In addition, the product should be calibrated with national or international standards which designated by MHLW. ● HbA1c, Cholesterol, Electrolyte, etc.

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