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Frequently Asked Questions (FAQ)

 

Pharmaceuticals and Medical Devices Agency (PMDA)

Q1-1
What does PMDA do?

PMDA is the regulatory agency which reviews quality, safety and efficacy of medical products to be marketed in Japan from scientific aspect. Please note that we do not provide the service to introduce/intermediate any company/organizations in Japan.
For more information: Outline of PMDA
 

Q1-2
May I use contents published on the PMDA website?

It is allowed to use contents of the PMDA’s website freely without any advance notice to PMDA as described in the “Website Policies” page unless otherwise specified.
Please make sure to confirm the website policies before using the contents of PMDA’s website.
 

Q1-3
May I use the PMDA logo?

All rights including the copyright of the PMDA logo belong to PMDA. Please contact us about the usage of the PMDA Logo from this E-mail form.

 

Q1-4
How can I get information on recruitment?

For the information on job openings in the PMDA, please refer to “Recruitment Information” page (available only in Japanese) and apply for a position that suits your skills.
For your information, Japanese language skill is required because our working language is Japanese.
 

Application for Product Approval

Q2-1
I would like to know about the Japanese approval system for pharmaceuticals / medical devices.

You can find information on Japanese approval system on “Outline of Reviews and Related Services” page.
 

Q2-2
What is the classification for application of the product in Japan (Pharmaceuticals, Quasi-drugs, Cosmetics, Medical devices, etc.)?

The procedure for classification varies according to each product. For this reason, the Ministry of Health, Labour, and Welfare (MHLW) is able to assist with questions related to the product. When you intend to take certain procedures pertaining to the Act on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices (PMD Act), you should confirm the requirements with the designated Marketing Authorization Holder in Japan.
Additional information can be found on MHLW's website.
 

Q2-3
I would like to know procedures for marketing medical devices in Japan.

If you would like to import and market a medical device in Japan, firstly you have to clarify if the product is classified as a medical device, which is regulated by the PMD Act. To find out if your product is considered as a medical device, please contact competent prefectural pharmaceutical affairs division where the distributor's office is located. If a product is categorized as a medical device, the product is necessary to be granted approval, certification or notification for marketing depending on the class of medical devices to which the product belongs. For the classification of medical devices in Japan, please refer to “Regulations and Approval/Certification of Medical Devices” page for details. These procedures should be implemented by Marketing Authorization Holders located in Japan.
For your information, you can also find information on “Accreditation of Foreign Manufacturers” page.
 

Q2-4
How can I learn whether our product is categorized as a medical device or In-Vitro Diagnostics (IVDs) in Japan?

PMDA does not make a decision on whether an individual product is categorized as a medical device or IVDs. If you would like a formal device determination, we suggest that you contract the Marketing Authorization Holder who resides in Japan (J-MAH) first, and consult through this J-MAH with the local authority which has jurisdiction over the J-MAH, or please contact the MHLW directly.
As for determination of eligibility for Software as a Medical Device (SaMD), you can use PMDA’s consultation service for SaMD (available only in Japanese) and consult through this service with Compliance and Narcotics Division of the MHLW.
 

Q2-5
Where can I find information on criteria of medical devices and In-Vitro Diagnostics (IVDs)?

You can find information on criteria for medical devices and IVDs on Criteria for Medical Devices.
 

Q2-6
Can I submit foreign clinical data based on the clinical studies conducted outside of Japan for Marketing approval for medical devices in Japan?

Yes, PMDA accept and review foreign clinical data of medical devices which are applied for Marketing approval in Japan. Please see relevant notifications:
- "Handling of the data of clinical studies for medical devices conducted in foreign countries (March 31, 1997, YAKUHATSU No. 479) (English)"
- "Handling of clinical study data on medical devices which was carried out in foreign countries (March 31, 2006, YAKUSHOKUKIHATSU No.0331006) (English)"
The past record of the number of foreign clinical data of medical devices PMDA has accepted is shown below.

  2012 2013 2014 2015 2016
Foreign Clinical Data Only 23 34 28 23 30
Both Foreign and Japanese Clinical Data 3 8 2 11 5
Japanese Clinical Data Only 23 24 11 24 9
Number of Medical Devices Approved with Clinical Data Review

You can also see the details of approved medical devices including the source of clinical data in PMDA annual reports, for example, "Reference 4 Medical devices approved based on clinical trial results" in the Supplementary Information section of the "PMDA Annual Report FY 2015 (English)".
 

Q2-7
Does PMDA provide or recommend any English-language publications that may be helpful for becoming familiar with regulations concerning drug, medical device, and regenerative medicine products in Japan?

As PMDA is an independent administrative institution, it must maintain a neutral and impartial position, and as such PMDA is unable to recommend any particular company or publication. PMDA only provides information related to official government publications released by the MHLW. You may find a tentative English translation of the PMD Act on this Japanese Law Translation Database System managed by the Ministry of Justice. However, only the original Japanese text of this law shall have legal effect, and this translation is to be used solely as reference material to aid in the understanding of this law.
For your reference, regulatory information (e.g, Ministerial Ordinances, Regulatory Notifications, etc) is provided here:
Regulatory Information
 

Q2-8
Will PMDA provide a list of Japanese Marketing Authorization Holders?

PMDA is NOT able to provide specific information such as a list of Marketing Authorization Holders. For your information, we only provide a link page including Japan's pharmaceutical and medical device manufacture association which Japanese Marketing Authorization holders belong to at.
 

Q2-9
Can we file our application for product approval to PMDA in a language other than Japanese?

No, PMDA does not accept applications in other languages. Japan's Pharmaceutical Affairs Law requires all forms related to the marketing application to be submitted in Japanese.
 

Q2-10
How can our company receive PMDA’s opinion in regards to R&D or regulatory submission of our product in Japan?

Various types of consultation services are provided by PMDA. For further information, please refer to “Consultations” page.
 

Q2-11
Can PMDA provide me with information about the medical products under review?

No. PMDA does not provide information on any products of which application for marketing approval are already submitted or under review.
 

Reviews

Q3-1
Where can I find information on fees on this website?

You can find information on fees for reviews etc., consultations and PMDA’s inspections on:
“Fees for reviews and face-to-face consultations, etc.“ page (available only in Japanese).
 

Q3-2
Where can I find information on review timeline for medical products?

You can find information on standard review timeline on (available only in Japanese):

For your information, you can also find total review time for New Drugs and New Medical Devices from this Profile of Services.
 

Q3-3
I would like to know systems to further accelerate and improve product reviews in Japan.

You can find information on systems to further accelerate and improve product reviews on MHLW's website.

For details of each system, please contact the MHLW.
 

Master File System

Q4-1
I would like to know about an outline of the drug master file (DMF) system.

You can find information on the DMF system on “Master File System” page.
 

Q4-2
What is the confidentiality policy of the PMDA regarding DMF?

The provisions concerning confidentiality obligations are prescribed under the Articles 13 and 42 in Act on Pharmaceuticals and Medical Devices Agency, Independent Administrative Agency. The act is published only in Japanese at present. It is not a government publication material but is useful as reference. (ISBN: 978-4-8407-3999-3)
the Articles 13 in the Act on PMDA (Responsibility to Maintain confidentiality).
The executives, personnel or persons who formerly held such positions in the PMDA shall not leak or make fraudulent use of secrets learned during their work.
the Articles 42 in the Act on PMDA.
Persons violateing the provisions of Articles 13 shall be subject to penal servitude of one year or less or a fine of 1,000,000 yen or less.

 

Q4-3
Is there a list of approved DMFs (APIs) available for the industry to view on the PMDA website?

Manufactures of APIs can voluntarily register DMFs without any review by PMDA. Each DMF is not reviewed alone, but reviewed in the process of product review.
Information on whether or not an individual DMF was referenced in an application for a drug product is not disclosed.
Only a list of registered DMFs is disclosed (available only in Japanese).
 

Accreditation of Foreign Manufacturers

Q5-1
Please tell me about an overview of Japanese accreditation of foreign manufactures.

You can find information on Japanese accreditation of foreign manufactures on “Accreditation of Foreign Manufacturers” page.
 

Q5-2
My manufacturer has already obtained the accreditation of foreign manufactures in Japan, but has no certificate at hand. To whom shall I ask? How about renewal/change of accreditation?

Please contact your Marketing Authorization Holder or in-country caretaker in Japan. The accreditation certificate is sent from PMDA to them. If you need to reissue the certificate or renew/change the accreditation, please submit an application for reissuance/renewal/change through them. For further information on accreditation of foreign manufacturers, please refer to “Accreditation of Foreign Manufacturers” page.
 

Q5-3
How can I check the expiration and renewal status of my accreditation of foreign manufactures?

Please check the accreditation list provided on “Publication of Foreign Manufacturer Accreditation Number” page (available only in Japanese).
The expiration date and the status of the application of renewal of the current accreditation can be found on the list. If an "Application for Renewal of Accreditation" has been received by PMDA, open circle (○) is indicated.
 

Information for Approved Products

Q6-1
I need a package insert and other information of a certain drug, a medical device, or a regenerative medical product.

Package inserts and other information of prescription drugs, some OTC drugs, medical devices, and regenerative medical products approved and distributed in Japan can be searched on “Search system for each product type” page (available only in Japanese).

Lists of new drugs (except for generic drugs and OTC drugs), some medical devices, and regenerative medical products approved after FY 2004 are provided on “Information for Approved Products” page.
 

Q6-2
Where can I find information on certified medical devices?

A list of medical devices certified by Registered Certification Bodies by Ministry of Health Labour and Welfare in Japan (RCB), i.e, Class II devices and some Class III devices, is published on “Publication of List of Certified Products” page (available only in Japanese) and you can search by certification number or name of the product.
 

GMP/QMS

Q7-1
Where can I find information on the results of GMP?

Though the list of Accredited Foreign Manufacturers is published on “Publication of Foreign Manufacturer Accreditation Number” page (available only in Japanese), whether the GMP inspection was conducted, inspection date and inspection result are not publicly available at present.
For more information: GMP
 

Q7-2
I would like to know the validity period of GMP certificate issued in Japan.

GMP certificates are issued by the MHLW, not by PMDA.
Those GMP certificates are issued without date of validity and reflect status of manufacturing site at the time of inspection.
For more information: GMP
 

Q7-3
Where can I find an English translation of MHLW Ministerial Ordinance No. 169, which specifies Japanese Medical Device QMS requirements?

PMDA provides an English translation of the latest QMS ordinance except Chapter 2 and 6 on “Revision of Japanese Medical Device QMS requirements” page.
In addition, PMDA also provides an English translation of comparison table between ISO 13485 and MHLW MO 169 Chapter 2.

 

Post-marketing Safety

Q8-1
How can we submit post-marketing safety reports of drugs, medical devices, and regenerative medical products?

  • Reports from Marketing Authorization Holder

Post-marketing safety reports have to be submitted by a Japanese Marketing Authorization Holder distributing the product in Japan as explained ”Reports from MAH” page (available only in Japanese). If the product is foreign-manufactured under Foreign Exceptional Approval, a designated Marketing Authorization Holder in Japan is required to submit post-marketing safety reports in good communication with its partner. Other considerations in safety reporting are explained in Article 68-10 of the PMD Act.

  • Reports from Healthcare Professional

You can submit safety reports from ”Reports from HCP” page (available only in Japanese).

  • Reports from Patients

You can submit safety reports from ”Reports from patients” page (available only in Japanese).
 

Q8-2
I would like to search or download information about case reports on suspected adverse drug reactions (ADRs) and malfunctions. I prefer the information in English, if available.

Please refer to the following pages to see information about case reports:
Drugs
Medical devices
Regenerative medical products
Regarding case reports on suspected ADRs, you can search the information on the website or download the information as a comma separated value (CSV) file from the website. As to case reports on suspected malfunction, you can search the information on the website, but the CSV format of the information is not available.
The information about case reports on suspected ADRs and malfunctions is available only in Japanese language.
 

Q8-3
I would like to learn about post-marketing pharmacovigilance for drugs and medical devices in Japan.

You can find information on safety measures in Japan on “Outline of Post-marketing Safety Measures” page.
 

Clinical trials

Q9-1
How can I get onto or learn about a clinical trial?

Unfortunately, PMDA does not provide the information on the specific clinical trials. Concerning the specific clinical trial, please contact directly those who develops. For your information, please refer to the Clinical Research Portal Website provided by the National Institute of Public Health (NIPH) of Japan. It can be used to cross-search the content of four national clinical research information registries:
Japan Registry of Clinical Trials (JRCT),
The University Hospital Medical Information Network Center (UMIN-CTR),
The Japan Medical Association Center (JMACCT),
The Japan Pharmaceutical Information Center (JAPIC).
 

Q9-2
I would like to learn about adverse event report during clinical trials.

Safety reporting to Japanese regulatory agency should be made in accordance with ICH E2B(R3).
For further detail on reporting, please refer to the following information:

If the sponsor does not reside in Japan, an in-country representative/agent needs to report adverse events to PMDA on behalf of the sponsor. Please ask your Japanese in-country representative/agent to contact PMDA regarding the format, mode, and contact for reporting.
 

Q9-3
I would like to know how to import/supply/use of unapproved drugs or medical devices for clinical trials.

In order to import unapproved drugs or medical devices for the use of clinical trials in Japan, you need to obtain "Yakkan" certificate from Regional Bureau of Health and Welfare.
For details, please contact Regional Bureau of Health and Welfare that resides in the airport where you will import your products.
Please note that the required documents are different depending on whether the importer is a company or a doctor, etc.
 

Medical advice

Q10-1
Can PMDA give me any advice on my treatment or medical condition?

No. PMDA cannot advise individual patients on their treatment or condition. We suggest that you discuss these issues with a healthcare professional, such as your doctor or pharmacist.
 

Pricing, reimbursement and patents

Q11-1
Does PMDA have any information on the price or reimbursement of medical products?

No. Pricing and reimbursement of medical products falls under the jurisdiction of the MHLW. Please contact the MHLW.
 

Q11-2
Can PMDA provide me with information on patents on medical products?

No. PMDA is not responsible for patents on medical products in Japan. Trademarks of all products, including medical products, are registered with the Japan Patent Office (JPO). Please contact the JPO.
 

Food products including supplements and cosmetics

Q12-1
How can I learn about the regulation of supplements?

Supplements are generally classified as food products in Japan, and food products including supplements fall under the jurisdiction of MHLW. Please contact the MHLW.
 

Q12-2
How can I learn about the regulation of cosmetics?

To sell cosmetic products in Japan, regulatory application for marketing approval is not necessary but the product needs to comply with the Standards for Cosmetics.
The Standards for Cosmetics and MHLW notifications related to cosmetics and quasi-drugs are available on this MHLW's webpage (available only in Japanese). For details, please contact the MHLW.
Please note that products contain active ingredients are generally classified as quasi-drugs in Japan and regulatory application for marketing approval is necessary.
 

JP-related questions

For questions on Japanese Pharmacopoeia (JP), please refer to this JP FAQ.
Note: The Japanese Pharmaceutical Excipients (JPE) and Japanese Pharmaceutical Codex (JPC) fall under within the jurisdiction of the MHLW.
 

Others

Q14-1
How can I learn about the pathway in Japan to provide access to unapproved medical products?

Information about the Expanded Access Program (Clinical Trials Conducted on Ethical Grounds; Japanese Compassionate Use System) in Japan is provided on PSEHB/ELD Notification No. 0122-7.
Please refer to the list of on-going clinical trials conducted on Ethical Grounds on “Disclosure of clinical trial information” page (available only in Japanese)
In terms of access to unapproved medical products whose clinical trials are not conducted, please refer to this MHLW's webpage (available only in Japanese) on the coverage of medical expenses combined with treatment required by patient outside insurance coverage "Kanjya Moushide Ryouyou" system of the MHLW.
Though it will not be covered by Japanese National Health insurance system, it is allowed to privately import unapproved medical products and use them for patients at a physician's responsibility unless the product is prohibited to import by the Narcotics and Psychotropics Control Act or Stimulants Control Act.
Please contact the regional Bureau of Health and Welfare, where the customs office which you request customs clearance for private import is located, for detailed information on required processes.
 

Q14-2
How can I get information on distribution and import of medical products?

The matters regarding distribution and import of medical products fall under the jurisdiction of the MHLW. Please contact the MHLW.
 

Q14-3
How can I get information for those who are bringing medical products for personal use into Japan distribution and import of medical products?

The matters regarding private import of medical products fall under the jurisdiction of the MHLW. Please refer to MHLW’s website. For details, please contact the MHLW.
 

Q14-4
Does PMDA have information on the license such marketing license for medical products and license for wholesale distribution?

No. For the matters relating to marketing license (including appointment of marketing directors) for medical products and license for wholesale distribution, please contact responsible department of the Japanese prefectural government where the place of a business office is located.
 

Q14-5
I would like to know the regulation of medical products for animal use in Japan.

The regulation of medical products for animal use in Japan falls under the jurisdiction of the Ministry of Agriculture, Forestry and Fisheries (MAFF). Please contact the MAFF.
 

Q14-6
I would like to make a report concerning an act in violation of the PMD Act, etc. within the enterprise.

You can submit a report concerning an act in violation of the PMD Act, etc. (including Japanese ministerial ordnances such as GCP and GMP/QMS) through this MHLW’s webpage (available only in Japanese) since the MHLW has an official reporting channel for whistleblowing.
 

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Chiyoda-ku, Tokyo 100-0013 Japan

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