Regulatory authority of japan

Regulatory authority of japan

1. Regulatory authority of Japan - Aaditya Thole M.pharm (pharmaceutics)

2. Regulatory bodies in Japan

3. The Ministry of Health , Labour and welfare(MHLW) The M inistry of H ealth, L abour and W elfare (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 and Medical Devices Agency (PMDA)

6. Introduction It was established in April 01, 2004 The main regulatory body of PMDA located in Kasumigaseki , Chiyodaku - Tokyo.

7. Continued PMDA (Pharmaceuticals and 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.

8. Website

9. Organizational chart of PMDA

10. What PMDA does

11. Functions of PMDA

12. Drug approval process in Japan

13. Work flow and review

14. IND filing process

15. IND filing process continued

16. Orphan drugs

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

19. THANK YOU