PRESENTED BY— SATHEESHS

1ST YEAR M
.PHARM
SRM UNIVERSITY

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• CAPITAL–Tokyo

• LANGUAGE–japanese

• ETHNICGROUPS– 98.5%
JAPANESE

 0.5%KOREA

 0.4%CHINIIESE

 0.2%BRAZILIAN
• GDP--$4.843trillion
• CURRENCY--yen
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 PMDA is the agency that
reviews submissions of
applications for drug approval,
foreign manufacturer
accreditation (FMA), drug
master file (DMF) registration,
etc
Submissions of
applications,for
drug
Established in 1 april
approvalFMA &
2004 DMF

2. Its obligation is to protect the

public health by assuring safety,
efficacy and quality of
pharmaceuticals and medical
devices.

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5
1. ETHICAL DRUGS

2. PRESCRIPTION DRUGS

3. OTC DRUGS

• Class 1 drug products

• Class II drug products
• Class III drug products

4. ORPHAN DRUGS 5
 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 6
 Application Form (Written)
 Application letter (XML)
 Protocol
 Case report form
 IB
 ICF
 Written reason for appropriate request for
clinical trial
 Pharmaceutical affair law
 Pharmacist law
 Law concerning securing stable supply of
blood products
 Poisonous and deleterious substance control
law
 Narcotics and psychotropic control law
 Cannabis control law
 Opium law
 Stimulants control law copyright
 In 2015, the MHLW instituted the SAKIGAKE
(meaning pioneer or forerunner in Japanese)
designation system for medical products
 In October 2015, the MHLW granted
SAKIGAKE designation to ASP2215 for
relapsed/refractory FLT3 mutation-positive
acute myeloid leukemia and Pembrolizumab
for advanced gastric cancer in the oncology
field
 Furthermore, the MHLW revised the
Pharmaceutical Affairs Law (PAL) and
implemented the Law on Securing Quality,
Efficacy and Safety of Products including
Pharmaceuticals and Medical Devices (PMD
act) in November 2014
 The regulatory authority of Japan is ministry of
Health, Labour and Welfare (MHLW). In this
drug approval process priority review takes
180 business days and standard review takes
240 business days.
 Pre-clinical and clinical timelines vary
depending on the type of drugs, clinical results
etc. Pharmaceuticals and Medical Devices
Agency (PMDA) Phases from clinical trials to
New Drug Application.
 . Non clinical testing involves animal testing
followed by Phase I trials where tests are
conducted in healthy volunteers for safety
assessment.
 Phase II trials in the first stage is conducted in a
small group of patients where initial
assessment of efficacy is performed and in the
last stage the dosage with which efficacy in
patients is determined.
 The Phase III trials are conducted in larger
group of patients where controlled and
uncontrolled trials to confirm efficacy and
safety in actual clinical use. Then applicant
submits New Drug Application (NDA) to
PMDA
 . It reviews NDA, conducts evaluation for
safety, efficacy and quality, and issues
recommendation to the Ministry of Health,
Labour and Welfare (MHLW) Outside experts
nominated by Pharmaceutical Affairs and Food
Sanitation Council provide expert advice and
MHLW reviews PMDA recommendation and
makes final marketing authorization decision.
Non Clinical test – Animal testing

Phase 1 trials – Conducted in healthy

Volunteers - mainly for safety Assessment

Phase 2 Trials(First Stage)

Conducted in small group of patients
Initial Assessment of efficacy
 Phase 2 Trials- Late stage
 Conducted in patients
 Determine the dosage form with efficacy

 Phase 3 Trials Conducted in large group of patients

 Controlled and uncontrolled trials to confirm safety
and efficacy in actual clinical use

 Applicant submits New drug application (NDA) to

PMDA
 PMDA reviews NDA, conducts evaluation for safety,
efficacy and quality, and issues recommendation to
the Ministry of Health, Labour and Welfare (MHLW).

 MHLW reviews PMDA recommendation and makes

final marketing authorization decision

 Outside experts nominated by Pharmaceutical Affairs

and Food Sanitation Council provide expert advice
 Japan Regulatory Drug Approval Process

 Standard Review --240 business days*

 Priority Review --180 business days†
 We collect safety information, such as adverse
drug reactions, infections caused by use of
pharmaceuticals and medical devices and
adverse events caused by medical devices from
companies and healthcare professionals. That
information is stored into a database for
scientific analysis and investigation. Findings
from investigation are reported to the MHLW,
which would result in administrative actions to
ensure safety use of pharmaceuticals and
medical devices, etc.

 We develop and implement new methods and
techniques for post-marketing safety
operations, such as data mining method and
sentinel medical institution network, with a
view to enhancing quick response to problems
and taking accurate safety measures. Thus it
enables us to prevent and predict safety
problems.
 We provide information on pharmaceuticals and
medical devices on the website in order to promote
their proper use, by listing package inserts, product
recalls, drug guide for patients and other urgent safety
alerts as well as reports on adverse drug reactions and
adverse events of medical devices submitted to the
PMDA from companies. We also offer free e-mail
information delivery services providing latest safety
information to the health care professionals.
 We provide telephone consultation services on
pharmaceuticals and medical devices for consumers,
etc.
 We collect safety measure contributions from
marketing authorization holders of pharmaceuticals
and medical devices.