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.
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Drug approval process in japan
1. FACILITATED BYâ
DR. M.P. VENKATESH
ASST. PROFFESOR
REGULATORY AFFAIRS
GROUP
DEPT. OF
PHARMACEUTICS
JSSCP, MYSURU
PRESENTED BYâ
MANISH KUMAR
1ST YEAR M
.PHARM
JSSCP, MYSURU
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2. ⢠CAPITALâ Tokyo
⢠LANGUAGE-- japanese
⢠ETHNIC GROUPSâ 98.5%
JAPANESE
ďś0.5% KOREA
ďś0.4% CHINESE
ďś0.2% 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 1âgeneral 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.
ďOnly a MAH license holder can submit an approval application
for a product.
ďTo obtain product approval, the manufacturer in Japan needs to
be licensed. For a foreign manufacturer, a Foreign Manufacturer
Accredited Certificate (FMA) is required.
ďThe 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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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 â 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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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.
ďźPre-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.
ďźPre-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. ďźPre-market Approval (Shonin) - CLASS II, III & IV MEDICAL DEVICES
To register and market a âHighly Controlled Medical Deviceâ 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
ďśA 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 âAccredited Foreign Manufacturerâ.
ďśIn addition, a foreign manufacturer intending to manufacture only drug
substances to be exported to Japan also need to obtain accreditation as an
âAccredited Foreign Manufacturerâ
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21. An âApplicantâ is required to submit âApplication for
Accreditationâ (Form No. 18 in the PAL Enforcement
Regulations) that is addressed to the Minister, and
âApplication for Accreditation Examinationâ [Form No.16-
(2)]
Documents to Be Attached to Accreditation Application:-
ď§A medical certificate from a physician which indicates
whether or not an âApplicantâ has mental disorders or is
addicted to narcotics, cannabis, opium or stimulant drugs.
ď§ A curriculum vitae of the person who is responsible to the
manufacturing establishment
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22. QUASI DRUGS
ďśA medical certificate for an âApplicantâ from a physicianâ
and âa curriculum vitae of the person who is responsible for
the foreign manufacturing establishment.
ďśIn this case, the âApplicantâ can omit filling out the space
of âAddressâ in the section of âPerson who is responsible
for manufacturing establishment
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23. CHANGE RENEWAL
must submit a form,
âApplication for
Change/Additionâ (Form No.
21 specified in the PAL
Enforcement Regulations)
Unless an âAccredited Foreign
Manufacturerâ renews their
accreditation, using a form of
âApplication for Renewal of
Accreditationâ , within its 5
year effective period, their
accreditation becomes null and
void.
accredited to new categories
while cancelling their
previously accredited
categories.
Form No â 20 is the
application for renewal.
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24. OUTLINE
ďźMF registrant : A manufacturer of drug substances, etc.
ďźDocuments required : Application form , supporting data
ďźWhen to submit : As needed
ďźBenefits of using MFs:
Protection of manufacturers intellectual properties.
Smooth operation of regulatory marketing approval process
ď MF system is not mandatory
ď PMDA only inspect whether the application is in correct format
or not
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25. ďśQuasi 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. ďś Pharmaceutical product materials(materials
of pharmaceutical products with special
dosage form, etc.)
ďś Excipients (new excipients , new pre-mix
excipients)
ďś Materials for medical devices.
ďś Drug substances, intermediates
ďś Containers, packaging materials.
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