this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.

1. PRESENTED BY : SANDEEP BANSAL
CLASS : M.PHARMACY 1st year
(DRA)
ROLL NO.180000802004

2. Pharmaceutical and medical device agency (PMDA).
Organization of PMDA.
Pharmaceutical laws and regulations.
Drug master file system in Japan.
Drug regulatory approval procedure in Japan.
IND and NDA applications.
Post marketing surveillance in Japan.
Japan cosmetic regulations.

3.  PMDA (Pharmaceuticals and Medical Devices Agency) is
Japanese regulatory agency, working together with Ministry of
health and labour welfare (MHLW).
 The PMDA was established in April 2004 in order to serve in
areas of review of drugs and medical devices, post-marketing
safety measures, relief services for adverse health effects.
 Our obligation is to protect the public health by assuring
safety, efficacy and quality of pharmaceuticals and medical
devices.
 The role of the PMDA is to provide consultations concerning
the clinical trials of new drugs and medical devices, and to
conduct approval reviews and surveys of the reliability of
application data.

4. ◦ Drug and medical device testing:
◦ Scientific review of market authorization applications based
on Japanese pharmaceutical law.
◦ Advice in clinical trials or in the preparation of dossiers for
the registration procedure (New Drug Applications (NDA).
◦ Inspection and conformity assessment of Good Clinical
Practice (GCP), Good Laboratory Practice (GLP), and Good
Practice Systems and Programs (GPSP)
◦ Auditing of manufacturers to ensure they conform to Good
Manufacturing Practice(GMP) and have a suitable Quality
Management System(QMS).

5.  It consists of the ministry proper, affiliated institutions,
councils, local branches, and external organizations.
 The ministry proper includes the Minister's Secretariat, 11
bureaus, and the Director-General for Policy Planning and
Evaluation.
 Councils include the Social Insurance Council, Pharmaceutical
Affairs and Food Sanitation Council (PAFSC), and other
organizations.
 Affiliated institutions include the National Institute of Health
Sciences and the National Institute of Infectious Diseases.
 Local branches are regional bureaus of health and welfare and
prefectural labor bureaus. The external organizations are the
Social Insurance Agency and the Central Labor Relations
Commission.

7.  Pharmaceutical administration in Japan is based on
various laws and regulations, consisting mainly of:
1. The Drugs and Medical Devices Law,
2. Law Concerning the Establishment for
Pharmaceuticals and Medical Devices Organization,
3. Law Concerning Securing Stable Supply of Blood
Products,
4. Poisonous and Deleterious Substances Control Law
5. Narcotics and Psychotropic Control Law
6. Cannabis Control Law,
7. Opium Law, and
8. Stimulants Control Law.

8.  A DMF is a system to register confidential data on quality,
manufacturing methods, etc. of a drug substance used for a
drug. Domestic and foreign drug manufacturers register their
DMFs to the PMDA on a voluntary basis.
 The manufacturer of the drug substance can be reviewed by
the competent Japanese authority without sharing information
containing details on its manufacturing methods, production
management and quality control with the manufacturers of the
drug product.
 DMF is reviewed at the time of the approval review for the
pharmaceutical products quoting DMF. At the time of DMF
registration, PMDA checks whether it is written in the correct
format, e.g., minimum required items are included
(application) and data is attached (CTD M3).

9.  The entire process of approval review from review-
related inspections and clinical trial consultation to
review works is undertaken by the PMDA.
 Application forms for approval to market drugs are
usually submitted to the PMDA.
 When application forms for new drugs are received
by the PMDA, a compliance review of the
application data (certification from source data), GCP
on-site inspection, and detailed review are undertaken
by review teams of the PMDA and the team prepares
a review report.

10.  Application form (written).
 Application letter (XML).
 Protocols.
 Case report form.
 IB ( investigator brochure).
 Written reason with appropriate request for clinical
trials.

11. ◦ IND application to be prepared in the common
technical document format (CTD) format.
◦ Pre-IND meeting.
◦ Subsequent to the application submission, PMDA
evaluates the application with respect to the preclinical
data and protocols for clinical studies etc.
◦ It may probably take 30 days for initial IND and 14
days for second IND.
◦ After PMDA completes the review, the IND fill will be
transferred to the IRB board for the review.
◦ IRB takes 1-4 weeks of time for the complete review.
◦ Once IRB approved the review than the clinical trials
on human beings will be started.

13.  The entire process of approval review from review-
related inspections and clinical trial consultation to
review works is undertaken by the PMDA.
 Application forms for drug marketing authorization
are submitted to the PMDA.
 When application forms for new drug s marketing
authorization are received by the PMDA, a
compliance review of the application data
(certification from source data), GCP on-site
inspection, and detailed review are undertaken by
review teams of the PMDA and the team prepares a
review report.

14.  The approval review process consists of expert meetings
of review team members and experts to discuss important
problems.
 A general review conference attended by team members,
experts and representatives of the applicant is held after
the expert meeting.
 It is necessary to submit a “list of persons involved in
compilation of attached data” and a “list of competitive
products and companies” in relation to persons who
participated in clinical studies submitted as application
data immediately after application submission, prior to the
expert meeting, and prior to meeting of the Committee on
Drugs.

18. ◦ Post-marketing surveillance (PMS) to assure the quality,
efficacy and safety of drugs after they go on the market and
to establish proper methods of use of drugs consists of three
systems: the ADRs and infections collection and reporting
system, the re examination system, and the revaluation
system.
◦ The re-examination system for new drugs was introduced in
the October 1979 amendment of the Pharmaceutical Affairs
Law, and Good Post-marketing Surveillance Practice
(GPMSP) came into effect from April 1993 to assure proper
implementation of PMS and also to assure the reliability of
such PMS data.

20. ◦ Cosmetic products in Japan are regulated by Ministry of
Health, Labour and Welfare (MHLW) under the
Pharmaceutical and Medical Devices Law (PMDL, formerly
Pharmaceutical Affairs Law). According to PMDL, beauty
products are divided into cosmetics and quasi-drugs and
regulation differs greatly between cosmetics and quasi-
drugs.
◦ Cosmetics refer to articles with mild action on the human
body, which are intended to be applied to the human body
through rubbing, sprinkling or other methods, aiming to
clean, beautify and increase the attractiveness, alter the
appearance or to keep the skin or hair in good condition.

21. ◦ Before obtaining license of marketing or importation,
manufacturers/importers of cosmetics shall submit 2
notifications to the competent authority:
 Cosmetic marketing notification
 Cosmetics (foreign manufacturer, importer) notification.
 The two notifications must either be accompanied by a list of
full ingredients from the importer’s supplier or manufacturer
or, if this list cannot be obtained, a record of the testing and
inspection results confirming the product does not contain any
prohibited ingredient combinations instead.

23.  Pharmaceuticals and Medical Devices Agency [Internet]. Pmda.go.jp. 2019
[cited 27 April 2019]. Available from: https://www.pmda.go.jp/english/.
 Pharmaceuticals and Medical Devices Agency, Japan - drug approval
[Internet]. Ss.pmda.go.jp. 2019 [cited 27April 2019]. Available from:
https://ss.pmda.go.jp/en_all/search.x?q=drug+approval&ie=utf8&cat=0&p
agemax=10&imgsize=1&pdf=ok&zoom=1&suggest=1&counsel=1&ref=w
ww.pmda.go.jp&pid=cGCqvKFAypc38kBls6lHVg..&qid=XWa44tkTt9qK
BO6nc1TrrEXm9Eg3J02D&d=Drugs.
 Organization | Pharmaceuticals and Medical Devices Agency [Internet].
Pmda.go.jp. 2019 [cited 27April 2019]. Available from:
https://www.pmda.go.jp/english/about-pmda/outline/0003.html.
 Guidance on Drug Master File System in Japan [Internet]. Pmda.go.jp.
2019 [cited 27 April 2019]. Available from:
https://www.pmda.go.jp/files/000227208.pdf.

24.  Master File System | Pharmaceuticals and Medical Devices Agency [Internet].
Pmda.go.jp. 2019 [cited 27 April 2019]. Available from:
https://www.pmda.go.jp/english/review-services/reviews/mf/0001.html.
 Drug Approval System of Japan - Google Search [Internet]. Google.com. 2019
[cited 27 April 2019]. Available from:
https://www.google.com/search?rlz=1C1RLNS_enIN743IN743&ei=RibFXJ1
NbS0mgfnioLoAQ&q=Drug+Approval+System+of+Japan&oq=Drug+Approv
al+System+of+Japan&gs_l=psyab.3..0i22i30j0i333l3.67937.70585..71559...1.
0..4.584.1596.0j2j3j5-1....3..0....1j2..gws-wiz.....6..0i71j35i39.4hjcWErlAYc.
 POST-MARKETING SAFETY MEASURES IN JAPAN [Internet].
Pmda.go.jp. 2019 [cited 27 April 2019]. Available from:
https://www.pmda.go.jp/files/000152319.pdf.
 The Regulation of Cosmetics in Japan [Internet]. Yakujihou.com. 2019
[cited 28 April 2019]. Available from:
http://www.yakujihou.com/img/CosRegulationJapan.pdf.