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Department of Regulatory
Affairs 1




PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese
regulatory agency, working together with Ministry of Health, Labour
and Welfare.

➢Our obligation is to protect the public health by assuring safety,
efficacy and quality of pharmaceuticals and Medical devices.
➢We conduct scientific reviews of marketing authorization
application of pharmaceuticals and medical devices, monitoring of
their post-marketing safety.
➢We are also responsible for providing relief compensation for
sufferers from adverse drug reaction and infections by
pharmaceuticals or biological products. 2 3


Pharmaceutical Laws and Regulations

Pharmaceutical administration in Japan is based on various laws and
regulations, consisting mainly of:
(1) The Pharmaceutical Affairs Law,
(2) Pharmacists 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 Psychotropic Control Law,
(7) Cannabis Control Law,
(8) Opium Law, and
(9) Stimulants Control Law. 4


The Pharmaceutical Affairs Law has 11 chapters and 91 articles as

Chapter 1: General provisions (Articles 1 and 2) (Purpose and
definitions of drugs, quasi-drugs, cosmetics, medical devices,
specially controlled medical devices, controlled medical devices,
general medical devices, specially designated medical devices
requiring maintenance, biological products, specified biological
products, pharmacies, manufacturing and marketing, in vitro
diagnostics, orphan drugs, orphan medical devices, and clinical trials)

Chapter 2: Prefectural pharmaceutical affairs councils (Article 3)
(Establishment of prefectural pharmaceutical affairs councils) 5


Chapter 3: Pharmacies (Article 4 – Article 11) (License standards, restrictions
on designation of pharmacies, supervision of pharmacies, duty of
supervisors, supply of information, etc. on pharmacy by proprietors,
requirements observed by proprietors, notification of suspension or
discontinuation of business, etc.)

Chapter 4: Manufacturers/marketers and manufacturers (Article 12 – Article
23) (License standards for manufacturers/marketers, licenses for
manufacturers, surveys by the PMDA, accreditation of foreign
manufacturers, manufacturing/marketing approvals, approval reviews
performed by the PMDA (KIKO), restrictive approvals, reexamination,
reevaluation, transfers, notification of manufacture/marketing, receipt of
manufacture/marketing notifications by the PMDA, drug master files,
registration by the PMDA, appointment of marketing supervisors-general,
items requiring compliance by manufacturers/marketers, notifications of
suspension or discontinuation, manufacturing approvals for drugs
manufactured overseas, notifications of changes in appointed
manufacturer/marketers, restrictive approvals of drugs manufactured
overseas, exceptions for drugs manufactured/marketed in pharmacies, etc.) 6


Chapter 4-2: Third-party certification bodies (Article 23-2 – Article 23-19)
(Certification of manufacturing/marketing of designated controlled medical
devices, appointment of manufacturer/marketers by overseas manufacturers
of designated controlled medical devices, cancellation of certification,
submission of reports, registration, standards for registration, disclosure of
registration, duties for reviews of criteria conformity certification,
operational standards manual, etc.)

Chapter 5: Retail sellers of drugs and retail sellers of medical devices
Section 1: Retail sellers of drugs (Article 24 – Article 38) (License for selling
drugs at stores, license for selling drugs by household distribution,
restrictions on drugs sold by household distribution, license for wholesale
distribution, and categories of non-prescription drugs, etc.)
Section 2 Retail Sellers, Leasers and Repairers of Medical Devices (Article 39 –
Article 40-4) (License for selling and leasing specially control medical devices,
appointment of managers, submission of notifications on selling and leasing
businesses of controlled medical devices, license for repairing medical
devices, etc.) 7


Chapter 6: Standards and government certification for drugs (Article 41 –
Article 43) (Japanese Pharmacopoeia and other standards, etc.)

Chapter 7: Handling of drugs
Section 1: Handling of Poisonous and Deleterious Substances, (Article 44 –
Article 48) (Labeling, restrictions on selling unsealed products, transfer
procedures, restrictions on supply, storage and exhibition)
Section 2: Handling of Drugs (Article 49 – Article 58) (Selling of prescription
drugs, items included on immediate containers and in package inserts,
prohibited entries, prohibition of manufacturing, giving and marketing of
drugs, etc.)
Section 3: Handling of Quasi-drugs (Article 59 – Article 60) (Items included
on immediate container, etc.)
Section 4: Handling of Cosmetics (Article 61 – Article 62) (Items included on
immediate container, etc.)
Section 5: Handling of Medical Devices (Article 63 – Article 65) (Items
included on immediate container, etc., prohibition of selling and
manufacture) 8


Chapter 8: Advertising of drugs (Article 68-2 – Article 68-11) (False
advertising, restrictions

Chapter 8-2: Exceptions for biological products (Article 69 – Article 77)
(Manufacturing supervisors, items included on immediate containers,
package inserts, etc., prohibition of selling and manufacture, explanation of
specified biological products by appointed health professionals, regular
reports on infectious diseases, preparation and retention of records on
biological products, guidance and advice, complication and examination of
information on regular reports on infectious diseases by the PMDA).

Chapter 9: Supervision (Article 6 9 – Arti cle 76-3 ) (On-si te inspe ctions, on-site

inspections by the PMDA, emergency orders, disposal, test orders, orders for

improvement, orders f or repl acemen t of m arketing superv isors-general,
supervision of househol d distrib utors, c ancellat ionsof a pprovals and licenses,
approvals to market dru gs man ufacture d overs eas, res trictive approvals and
accreditation of oversea s manuf acturers , proced ures for refusal of renewal of

licenses, exceptions for h earings, pharma ceutical affairs i nspecto rs) 9


Chapter 9-2: Handling of designated drug substances (Article 76-4 – Article
77) (Prohibition of manufacture, restriction of advertisement, inspection,
etc. of goods suspected of containing designated drug substances, disposal
and other measures, on-site and other inspections, and special handling of
designation procedures

Chapter 9-3: Designation of orphan drugs and orphan medical devices
(Article 77-2 – Article 77-2-6) (Designation, securing funds, tax relief
measures, notification of suspension of research and development,
cancellation of designations)

Chapter 10: Miscellaneous provisions (Article 77-3 – Article 83-5) (Supply,
etc. of information, promotion and enlightenment of proper use of drugs,
etc., prevention of hazards, reporting of adverse reactions, reporting of
recall, reporting, etc. to PAFSC, compilation and examination by the PMDA
of data from adverse reaction reports, preparation and retention of
records on specially designated medical devices, guidance and advice,
fees, conditions for licenses, etc., 10


application exemptions, etc., handling of clinical trial, review of clinical trial
applications by the PMDA, duties of prefectural governments, duties of the
Minister in emergencies, classification of clerical work of government
agencies, delegation of authority, interim measures, drugs for animals,
prohibition of manufacture/import of drugs for animals, prohibition of use,
regulations on the use of drugs for animals and regulations on the use of
other drugs)

Chapter 11: Penal provisions (Article 83-6 – Article 91) 11


Types of registration application 12



The Drug Master File (DMF) System, allows the manufacturers of Active
Pharmaceutical Ingredients (APIs) to submit the detailed information
(manufacturing methods, data, etc.) of APIs to the Review Authority
(PMDA).The registered information (manufacturing methods, data, etc.) is
quoted as the necessary information for an approval review of the
pharmaceutical products in which APIs is used.

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).

With the amendment of the Pharmaceutical Affairs Law enforced on April
2005, approvals for drug substances that had been necessary in the past
were no longer required (except for products listed in the Japanese
Pharmacopoeia) 13


and it is possible to omit documentation on drug substances attached to
applications if the marketing authorization holder presents a certificate in
writing of drug master file (MF) registration.

The MF system aims at protecting intellectual property of relevant information
and facilitating review work by allowing a registrant (master file registrant)
other than an applicant to separately submit information on quality and the
manufacturing method at the time of approval reviews of drug substances to
be used in drug products (Notification No. 0210004 of the Evaluation and
Licensing Division, PFSB dated February 10, 2005).

When an application to change of the MF is submitted, the marketing
authorization holder must submit a partial change application or a slight
modification notification for the MF depending on the contents of the change. 14


However, new registration applications are required in cases where there is
concern that the change in registered items will alter the basic nature of
registered items.

When approval applications are filed using MF registration, a copy of the
registration certificate and a copy of the contract with the registrant related
to MF utilization are required.

When inquiries concerning MF registration arise in the course of the review,
inquiries directly from the PMDA are made to the registrant or the drug
substance manager. When changes are made in the registered contents as a
result of the review, the MF registrant must submit an application for a
change in registered content 15 16


Thank You!! 17