ORGANIZATION OF PMDA /2 /JAPAN . PPT

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ORGANIZATION OF PMDA

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.

Types of registration application

 

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DMF SYSTEM IN JAPAN

 

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).

Notes) In Japan, the Drug Master File (DMF) is called “Master
File” or “MF

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) 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). MF
registration is optional. When an overseas drug substance

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manufacturer submits an MF registration application, it is
necessary to appoint a drug substance manager to handle the
activities of the MF registrant in Japan. When the registered
contents of the MF are changed, an application to change the
MF or a slight MF modification notification must be submitted.
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 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. However, when a change or changes are slight,
the marketing authorization holder is not required to submit a
partial change application or a slight modification notification of
approved items. In both cases, MF registrants must notify the
marketing authorization holder or the manufacturing approval
holder of the change(s). 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 or a slight modification notification
without delay.

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The Purpose of DMF is to protect the “know-how” of API
manufacturing methods against the marketing authorization
applicant (MAA) / holder (MAH) of pharmaceutical products.
DMF is not a patent.

 

DRUG REGULATORY APPROVAL PROCESS

PMDA provides the following services in drug regulatory

• Consultation
o Pharmaceutical affairs consultation on R&D strategy
o Clinical trial consultation

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• Regulatory review
o Pre-market review
o Re-examination
o Re-evaluation
o Use-results evaluation

• GLP/GCP/GPSP compliance assessments
• GMP/QMS/GCTP inspections
• Standards development

o Safety measures
o Relief services for adverse health events

 

 

REGULATORY CONSIDERATION FOR MANUFACTURING
,PACKAGING AND LABELLING OF PHARMACEUTICALS IN
JAPAN

To market the beauty products in Japan, one needs to know
answers to the following questions

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• How are cosmetics regulated in Japan?
• What are the regulatory requirements and processes for

different categories of cosmetic products?
• What are various licenses required for marketing?
• How do foreign manufacturers market their cosmetic

products in Japan?
• How to import cosmetic products after obtaining the

required approvals?

Let’s see how you can market your cosmetic product in Japan
stepwise.

Step 1: Review, categorize and perform ingredient analysis
for your product.

The application process for marketing licenses and
manufacturing licenses for quasi-drugs is the same as
cosmetics. But, the requirements and regulators vary as the
quasi-drugs. Regulators inspect Quasi-drugs more keenly for
safety.

The requirements and regulations vary between the category of
the product. Hence, before initiating any registration process,
you need to review and find your product category first.

The next step is to conduct ingredient analysis on samples by
testing at the facilities designated by the MHLW, owned or
contracted by manufacturers/importers. It includes analyzing
the list of ingredients whether it complies with Japanese
standards for cosmetics. However, this is not a mandatory
process, but authorities may ask for these reports during the
inspection.

Step 2: Obtaining Required Licenses.

The next step is obtaining the required licenses such as
Cosmetic Manufacturing License and Cosmetic Marketing
License from the respective regulatory authorities.

Foreign manufacturers, who intend to manufacture quasi-drugs
in foreign countries and export them to Japan, should be

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accredited by the MHLW as an “Accredited Foreign
Manufacturer”.

A Japanese marketing license holder who markets quasi-drugs
manufactured by a foreign manufacturer can make an
accreditation application on the manufacturer’s behalf.

Three categories of accreditation include,

• Accreditation for all or part of the manufacturing process
of quasi-drugs. and sterile quasi-drugs.

• Accreditation for packaging, labeling, or storage during the
manufacturing processes of a quasi drug.

Marketing License holders have to implement a set of
standards called

• Good Quality Practice (GQP) for maintaining the quality
of products, and

• Good Vigilance Practice (GVP) for undertaking
appropriate actions for safety management.

GMP (Good Manufacturing Practice)

PMDA conducts on-site and document-based GMP inspections
of domestic and foreign manufacturing sites for high-risk
products. The GMP inspection to ascertain whether the
manufacturing facilities and manufacturing and quality controls
comply with standards such as the Good Manufacturing
Practice (GMP).

Step 3: Cosmetic & Quasi-Drug Marketing Notification
Submission.

After the manufacturers obtain the license and before initiating
the import & selling, they shall submit cosmetic marketing
notification to the same authority who issued the cosmetics
marketing license.

1. Cosmetics Import Notification for Manufacture and Sales
2. Cosmetics (foreign manufacturer, importer) notification

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Step 4: Import your Cosmetics and Quasi Drugs into Japan.

All the requirements mentioned above have to be implemented
by importers with some slight differences. An importer can
handle the importation or distribution of its products by opening
a local subsidiary. In this case, the local company should follow
specific regulations to be an importer.

For the import of cosmetics and quasi-drugs into Japan, you
need to obtain

• Primary distribution approval
• Cosmetic Manufacturing License (packaging, labeling, and

storage)

 

Labeling & Claims For Cosmetics

Specified items must be entered on the immediate container of
drugs. The package inserts must contain indications,
dosage/administration, precautions, and precautions for
handling. All ingredients used as excipients must be included in
the package inserts of prescription and non-prescription drugs.
Entries in the package inserts of biological products are
specified in Notification No. 0515005 of the PFSB dated May
15, 2003 and labeling on the immediate container or packaging
of biological products is specified in Notification No. 0515017 of
the PFSB dated May 15, 2003. These specifications came into
effect from July 30, 2003. According to the Pharmaceutical
Affairs Law amended on April 1, 2005, a new regulatory
category for prescription drug labelling “Caution: Use only with
a prescription from a physician” and a labeling item for
manufacturer/marketing business instead of manufacturer or
importer were added (refer to Chapter 5). The Law for Partial
Amendment of the Pharmaceutical Affairs Law issued on June
14, 2006 (Law No. 69 enforced in 2009) requires the
manufacturer of non-prescription drugs to prescribe in labeling
matters specified in the Law in accordance of the level of
potential risks. To prevent medical accidents due to

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misunderstandings and assure traceability, implementation of
barcode labeling for prescription drugs (excluding in vitro
diagnostics) (Notification No. 0915001 of the Safety Division,
PFSB dated September 15, 2006) and preparation of
medication guides for patients are being promoted so that the
patient understands the prescription drug correctly and serious
adverse drug reactions can be discovered at an early stage
(Notification No. 0228001 of the Safety Division, PFSB and No.
0228002 of the Compliance and Narcotics Division, PFSB
dated February 28, 2006). Article 28 (Second-Class License for
Selling Drugs) and Article 29 (Prohibition of Selling Designated
Drugs) were amended by Law No. 69 dated June 14, 2006
entitled “Law to Partially Amend the Pharmaceutical Affairs
Law”, and the regulatory classification “designated drug” was
abolished on June 1, 2009. After amendment of the Law, it is
no longer necessary to specify “designated drug” but as an
interim measure, the old labeling system can be used in
manufacturing for one year and in product marketing for 2
years

Cosmetic labels need to be in Japanese, and full ingredient
labeling in Japanese is mandatory on the outer package of
cosmetics. Labeling with misleading expressions and
unapproved claims of functionality or efficacy are prohibited.

The Japan Cosmetic Industry Association (JCIA) has compiled
a Japanese version of the “List of Cosmetic Ingredient Label
Names” to use this in compliance with the PMDL’s
requirements to list all ingredient names on the labeling.

Companies can refer to the document to standardize the
Japanese name of ingredients. Companies can refer to the
document to standardize the Japanese name of ingredients
and can also file a request with the JCIA to revise a new label
name.

 

Post-marketing surveillance (PMS) system GVP, GPSP (GCP)

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Adverse reaction and infectious
disease reporting (ADR) system