Regulatory authority of japan

1. Regulatory authority of Japan
-AADITYA THOLE
M.PHARM (PHARMACEUTICS)

2. Regulatory bodies in Japan
Regulatory
bodies in Japan
MHLW PMDA
.

3. The Ministry of Health ,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 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. Drugs
Medical
devices
Regenerative
medicines
Quasi drugs
What PMDA does

11. Functions of PMDA

12. Drug approval process in Japan

13. Work flow and review

14. IND filing process
To be prepared
in the Common
Technical
Document
(CTD) format.
Pre-IND
meeting
PMDA
evaluates the
application

15. IND filing process continued
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.

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