1. The PMDA (Pharmaceuticals and Medical Devices Agency) is the Japanese regulatory agency that reviews submissions for drug and medical device approval to ensure safety, efficacy, and quality. It was established in 2004. 2. To market a drug in Japan, approval must be obtained for each product by demonstrating efficacy and safety through examinations. Foreign manufacturers must be accredited through the FMA process. Medical devices are classified and require pre-market notification, certification, or approval depending on the risk class. 3. Registering products in Japan requires navigating a complex process that can involve clinical trials and high fees. Pursuing product registration requires carefully considering the market demand to determine if pursuing approval is worthwhile.

1. FACILITATED BY—
DR. M.P. VENKATESH
ASST. PROFFESOR
REGULATORY AFFAIRS
GROUP
DEPT. OF
PHARMACEUTICS
JSSCP, MYSURU
PRESENTED BY—
MANISH KUMAR
1ST YEAR M
.PHARM
JSSCP, MYSURU
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2. • CAPITAL– Tokyo
• LANGUAGE-- japanese
• ETHNIC GROUPS– 98.5%
JAPANESE
0.5% KOREA
0.4% CHINESE
0.2% BRAZILIAN
• GDP-- $ 4.843 trillion
• CURRENCY--yen
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3. 1. PMDA (Pharmaceuticals and
Medical Devices Agency) is
Japanese regulatory agency,
working together with Ministry of
Health, Labour and Welfare.
2. Its obligation is to protect the
public health by assuring safety,
efficacy and quality of
pharmaceuticals and medical
devices.
PMDA is the agency that
reviews submissions of
applications for drug approval,
foreign manufacturer
accreditation (FMA), drug
master file (DMF) registration,
etc
Established in 1 april
2004
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Submissions of
applications,for
drug
approvalFMA &
DMF

4. 1. Pharmaceutical affair law
2. Pharmacist Law
3. Law Concerning the Establishment for
Pharmaceuticals and Medical Devices
Organization
4. Law Concerning Securing Stable Supply of
Blood Products
5. Poisonous and Deleterious Substances Control
Law,
6. Narcotics and Psychotropics Control Law,
7. Cannabis Control Law,
8. Opium Law
9. Stimulants Control Law Copyright
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6. • Pharmaceutical affairs law has 11
chapters and 91 articles
• Chapter 1—general provisions
• Chapter 2: Prefectural
pharmaceutical affairs councils
• Chapter 7: Handling of drugs
• Chapter 9-2: Handling of
designated drug substances
• Chapter 9-3: Designation of orphan
drug
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7. 1.ETHICAL DRUGS
2. PRESCRIPTION DRUGS
3. OTC DRUGS
• Class 1 drug products
• Class II drug products
• Class III drug products
4. ORPHAN DRUGS
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8. 1. When marketing a drug, it is necessary to obtain approval for
each product by receiving examinations on both its efficacy and
safety.
Only a MAH license holder can submit an approval application
for a product.
To obtain product approval, the manufacturer in Japan needs to
be licensed. For a foreign manufacturer, a Foreign Manufacturer
Accredited Certificate (FMA) is required.
The application is sent to the PMDA and further examination is
mainly conducted by this agency
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9. DESCRIPTION TOTAL FEE( YEN)
1. Drug containing new ingredient, drug for a
new route of administration, drug with a new
combination, biotechnology based existing drug
(excluding an orphan drug)
31,068,900
2. Drug containing new ingredient, drug for a
new route of administration, drug with a new
combination, biotechnology based existing drug
(orphan drug)
23,847,800
3. Drug with a new indication, drug with a new
dosage form, drug for new dosage and drug
with similar formulation (excluding an orphan
drug)
14,230,600
4. Drug with a new indication, drug with a new
dosage form, drug for new dosage and drug
with similar formulation (orphan drug)
10,957,300
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10. 1.APPLICATION FORM
(WRITTEN)
2.APPLICATION LETTER ( XML)
3.Protocol
4.Case Report Form
5.IB
6.ICF
7.Written reason with appropriate
requests for clinical trial.
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11. REQUIRED DOCUMENT CONTENTS MODULES
Documents on origin or
course of discovery and
usage
Status of development
and comparison of
package insert with
similar drug.
Module 1
Documents on
manufacturing method
and test methods
Structure determination
and physical – chemical
property
Module 3
Documents on stability Long term stability test,
accelerated test
Module 3
Documents on
pharmacologic actions
Test supporting efficacy
/safety pharmacology
Module 4
Documents on clinical
test results
Phase 1, phase 2, phase
3
Module 5
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12. PMDA
CONSULTATION
& IND
APPLICATION
PMDA REVIEW &
COMPLETION OF INQUIRES
IRB SUBMISSIONS &
IRB MEETING REVEIWS
IRB
APPROVAL&
CONTACT
WITH
HOSPITAL
STUDY
INFORMATION
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15. CLASSIFICATION OF
APPLICATION
QUASI
DRUGS
PHARMA
CEUTICL
S
MEDICAL
DEVICES
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17. • Registration of medical devices and
pharmaceuticals in Japan is complicated, and high
costs and long timeframes. In some cases,
Japanese regulators require clinical trials in
Japan to be conducted.
• Product registration in Japan needs to be pursued
carefully and only after determining that there is a
strong market demand for your product
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19. To market medical devices in Japan, the MAH must register the device
through the following procedures.
Pre-market Submission (Todokede) - CLASS I MEDICAl DEVICES
To register and market General Medical Devices (Class I devices), the MAH
must file a Pre-Market Submission to PMDA. There is no review/assessment
by the PMDA for Class I devices.
Pre-market Certification (Ninsho) - CLASS II MEDICAL DEVICES
Only Class II devices which are specified as Controlled Devices are subject
to Pre-market Certification. Class II devices other than Specified Controlled
Devices are subject to Pre-market Approval
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20. Pre-market Approval (Shonin) - CLASS II, III & IV MEDICAL DEVICES
To register and market a “Highly Controlled Medical Device” the MAH
needs to file a Pre-market Approval Application with the PMDA and
obtain their approval. Class II devices that are not Specified Controlled
Devices are also subject to Pre-Market Approval
ACCREDITATION OF FOREIGN
MANUFACTURERS
A foreign manufacturer (a person/ a company) intending to manufacture
drugs, quasi-drugs, or medical devices in foreign countries and export them
to Japan, is required to be accredited by the Minister of Health, Labour, and
Welfare as an “Accredited Foreign Manufacturer”.
In addition, a foreign manufacturer intending to manufacture only drug
substances to be exported to Japan also need to obtain accreditation as an
“Accredited Foreign Manufacturer”
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21. An “Applicant” is required to submit “Application for
Accreditation” (Form No. 18 in the PAL Enforcement
Regulations) that is addressed to the Minister, and
“Application for Accreditation Examination” [Form No.16-
(2)]
Documents to Be Attached to Accreditation Application:-
A medical certificate from a physician which indicates
whether or not an “Applicant” has mental disorders or is
addicted to narcotics, cannabis, opium or stimulant drugs.
 A curriculum vitae of the person who is responsible to the
manufacturing establishment
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22. QUASI DRUGS
A medical certificate for an “Applicant” from a physician”
and “a curriculum vitae of the person who is responsible for
the foreign manufacturing establishment.
In this case, the “Applicant” can omit filling out the space
of “Address” in the section of “Person who is responsible
for manufacturing establishment
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23. CHANGE RENEWAL
must submit a form,
“Application for
Change/Addition” (Form No.
21 specified in the PAL
Enforcement Regulations)
Unless an “Accredited Foreign
Manufacturer” renews their
accreditation, using a form of
“Application for Renewal of
Accreditation” , within its 5
year effective period, their
accreditation becomes null and
void.
accredited to new categories
while cancelling their
previously accredited
categories.
Form No – 20 is the
application for renewal.
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24. OUTLINE
MF registrant : A manufacturer of drug substances, etc.
Documents required : Application form , supporting data
When to submit : As needed
Benefits of using MFs:
Protection of manufacturers intellectual properties.
Smooth operation of regulatory marketing approval process
 MF system is not mandatory
 PMDA only inspect whether the application is in correct format
or not
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25. Quasi drugs developed in Japan for the
prevention of treatment of
HYPERPIGMENTATION DISORDERS
IT causes excess production of melanin which
causes irregular hyperpigmentation of skin
which further causes melasma
• now approved by MHLW
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26.  Pharmaceutical product materials(materials
of pharmaceutical products with special
dosage form, etc.)
 Excipients (new excipients , new pre-mix
excipients)
 Materials for medical devices.
 Drug substances, intermediates
 Containers, packaging materials.
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27. 1. http://www.pacificbridgemedical.com/regulatory-
services/registration/japan/#
2. http://www.emergogroup.com/services/japan/medical-
device-approval-japan
3. http://www.pmda.go.jp/english/service/pdf/acc/applica
tion.pdf
4. http://www.pmda.go.jp/english/service/pdf/acc/examin
atio.pdf
5. http://www.std.pmda.go.jp/stdDB/index_e.html
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