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Regulatory authority of japan
- 1. Regulatory authority ofJapan -AADITYA THOLE M.PHARM (PHARMACEUTICS)
- 2. Regulatory bodies inJapan Regulatory bodies in Japan MHLW PMDA .
- 3. The Ministry ofHealth ,Labour and welfare(MHLW) The Ministry of Health, Labour and Welfare (MHLW) is the governmental authority that 1.Issues almost all related ministerial orders 2.Administrative guidelines 3. Prepares relevant cabinet orders. MHLW Medicinal products
- 4. Role of MHLW •Also known as koro-sho in Japan • Provides regulations • In-charge of pharmaceuticals,veterinary and food safety products. • Handles clinical studies, approval reviews and post marketing safety ,measure.
- 5. The Pharmaceuticals andMedical Devices Agency (PMDA)
- 6. Introduction • It wasestablished in April 01, 2004 • The main regulatory body of PMDA located in Kasumigaseki, Chiyodaku- Tokyo.
- 7. Continued • PMDA (Pharmaceuticalsand Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare. • Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices. • It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety. • Also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.
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- 12. Drug approval processin Japan
- 13. Work flow andreview
- 14. IND filing process Tobe prepared in the Common Technical Document (CTD) format. Pre-IND meeting PMDA evaluates the application
- 15. IND filing processcontinued It may probably take 30 days for initial IND and 14 days for second and consecutive INDs After PMDA completes its review, the IND application will be transferred to Institutional Review Board (IRB) for the review. IRB takes 1-4 weeks of time for the completion of the review Once IRB provides a favorable response, IND application will be approved after which, clinical trials can be initiated on human subjects.
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- 17. Medical devices classification •Class I - General medical devices • Class II - Specified Controlled medical devices • Class II - Controlled medical devices • Class III - Highly Controlled medical devices • Class IV - Highly Controlled medical devices
- 18. References • https://www.pmda.go.jp/english/about-pmda/0004.html • http://marketrealist.com/2016/04/whats-drug-approval-process- japan/ •https://www.slideshare.net/manishkumar2613/drug-approval- process-in-japan • www.pacificbridgemedical.com/wp.../Japan-Drug-Regulatory- Overview-2014 • https://www.emergogroup.com/resources/japan-process-chart • https://www.ncbi.nlm.nih.gov/pubmed/10361082
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