Information

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¡ü ¡ÚFAQs¡Û What is the role of these FAQs?
¡ü ¡ÚFAQs¡Û How to purchase MedDRA Japanese version?
¡ü ¡ÚFAQs¡Û What is the difference between MedDRA English version and Japanese version?
¡ü ¡ÚFAQs¡Û What is J-currency flag?
¡ü ¡ÚFAQs¡Û What is the convention for J-currency maintenance?
¡ü ¡ÚPTC¡Û MedDRA® TERM SELECTION: Release 4.16
¡ü ¡ÚPTC¡Û MedDRA® DATA RETRIEVAL AND PRESENTATION¡§Release 3.16
¡ü ¡ÚPTC¡Û COMPANION DOCUMENT¡§Release 1.0, June 2018
¡ü ¡ÚRelated Documents¡Û MedDRA BEST PRACTICES DOCUMENT ¡Ê2018¡Ë
¡ü ¡ÚRelated Documents¡Û Unqualified Test Name Term List
¡ü ¡ÚRelated Documents¡Û Patient-Friendly Term List




¡ü ¡ÚFAQs¡Û What is the role of these FAQs?
JMO (MedDRA Japanese Maintenance Organization) is a partner of MSSO and the responsibilities of JMO are to maintain MedDRA in the Japanese synchronized with English version, to distribute within Japan and to promote the standardized utilization of MedDRA Japanese version.
Most of the JMO activities are performed with Japanese language. However, JMO has received several queries from overseas MedDRA users. These FAQs were developed based on those queries. If you have any questions or proposals for MedDRA/J or JMO activities, please do not hesitate to contact JMO. If your query seems to be suitable, JMO will update the FAQs section.
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¡ü ¡ÚFAQs¡Û How to purchase MedDRA Japanese version?
For MSSO subscribers outside Japan, please contact the MSSO. You can purchase MedDRA Japanese version from the MSSO.
In a case of a subsidiary company of a MSSO subscriber located in Japan, the subsidiary can purchase from JMO with Japanese language support, please contact with JMO.

If your company is not a current subscriber to MedDRA, and are a company headquartered in Japan, please contact the JMO. Companies headquartered outside of Japan should contact the MSSO.
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¡ü ¡ÚFAQs¡Û What is the difference between MedDRA English version and Japanese version?
The concept and the contents of MedDRA Japanese version are exactly the same as English and European-language versions. The update (version-up) timing is synchronized in both versions. However, due to language, culture, and medical practice differences between regions, there are some modifications. There are two major points.
One is MedDRA data model. MedDRA English version and European language versions are using the same data model. In the European language version, translated European terms are placed instead of English terms. In Japanese version of MedDRA English terms are the same as English version and Japanese terms are provided as additional ASCII files. So, MedDRA/J could be called as a bilingual, Japanese and English version.
The other major point is the J-currency flag. In MedDRA Japanese, each LLT has additional Japanese currency flag. This is explained on the next FAQ point.
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¡ü ¡ÚFAQs¡Û What is J-currency flag?
In MedDRA/J, there is an additional currency flag (located in a specific MedDRA/J ASCII file) for LLTs to address instances when two or more English LLTs are translated to the same Japanese term. Examples of these cases are British and American variant spellings, word order differences, singular vs. plural terms in English, word origin in Greek or Latin, etc.. MedDRA/J J-currency ensures the uniqueness of Japanese MedDRA terms by flagging only one of the duplicated translations as current for use. The Japanese MedDRA user believes that it is difficult to use the terminology without its ¡Æuniqueness¡Ç and that lack of uniqueness could lead to misunderstanding or confusion by the user. Just as users of English MedDRA require term ¡Æuniqueness¡Ç, so too do MedDRA/J users for Japanese terms.

Japanese regulations recommend (but do not mandate) use of Japanese current MedDRA terms for Japanese domestic cases. For foreign cases, only English current terms are required.

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¡ü ¡ÚFAQs¡Û What is the convention for J-currency maintenance?
The followings are conventions for maintaining the J-currency flag.
•All non-current terms in English MedDRA are flagged as non-current in MedDRA/J.
•LLTs that are identical to their parent PT are flagged as current in MedDRA/J. Any other LLTs which have an identical Japanese translation are flagged as non-current in MedDRA/J.
•When the same Japanese translation is given to several LLTs, and if none of those is identical to its PT, only one LLT which seems to be ¡Æmost appropriate¡Ç among them is flagged as current in MedDRA/J; all other LLTs are flagged as non-current. To determine the ¡Æmost appropriate¡Ç term, the JMO applies the following criteria:
-British spelling LLTs have priority of being flagged current in MedDRA/J.
-When several English descriptions share the same Japanese translation at the LLT level, the first term that is listed in the Japan Medical Terminology (compiled by Japanese Association of Medical Sciences Committee of Medical Terminology) is flagged as current in MedDRA/J. If none of them are listed in the Terminology, then descriptions in the main entries of Dorland¡Çs Illustrated Medical Dictionary and Stedman¡Çs Medical Dictionary receive preference for flagging as current in MedDRA/J.
-The English description which is most commonly used as medical terms in western countries is flagged as current in MedDRA/J.
-The term that is expressed in natural word order is flagged as current in MedDRA/J. For example, a term that is expressed as ¡Æadjective + noun¡Ç has preference over that of ¡Ænoun + adjective¡Ç.
-Acronyms, abbreviations, and terms containing have a lower priority for designation of currency in MedDRA/J.
-Terms containing conjunctions have a lower priority. For example, LLT Aortic aneurysm is flagged as current in MedDRA/J while LLT Aneurysm of aorta is non-current.

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¡ü ¡ÚPTC¡Û MedDRA® TERM SELECTION: Release 4.16
This MedDRA Term Selection: Points to Consider (MTS:PTC) document is an ICH-endorsed guide for MedDRA users. It is updated in step with new MedDRA versions. It was developed and is maintained by a working group charged by the ICH Management Committee.
The working group consists of representatives of ICH regulatory and industry members, the World Health Organization, the MedDRA Maintenance and Support Services Organization (MSSO), and the Japanese Maintenance Organization (JMO) (see the M1 MedDRA Terminology page under Multidisciplinary Guidelines on the ICH website for a list of current members).

And also, this PTC document is published on both website of MedDRA (http://www.ich.org/home.html) and ICH (https://www.meddra.org/how-to-use/support-documentation) at the same time.

¡¦Japanese MedDRA Term Selection: PTC document (MS-Word; docx) (HTML)
¡¦English MedDRA Term Selection: PTC document (MS-Word; docx) (HTML)
¡¦Japanese Redlined Document (PDF)
¡¦English Redlined (MS-Word; docx)
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¡ü ¡ÚPTC¡Û MedDRA® DATA RETRIEVAL AND PRESENTATION¡§Release 3.16
This time, it is a revised document (From release 3.15 to release3.16) for MedDRA version 21.1. Please refer the Redlined documents about summary of points of the changes.

And also, this PTC document is published on both website of MedDRA (http://www.ich.org/home.html) and ICH (https://www.meddra.org/how-to-use/support-documentation) at the same time.

¡¦Japanses MedDRA Data Retrieval and Representation: PTC document (MS-Word; docx) (HTML)
¡¦English MedDRA Data Retrieval and Representation: PTC document (MS-Word; docx) (HTML)
¡¦Japanese Redlined Document(PDF¡Ë
¡¦English Redlined Document (MS-Word; docx)
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¡ü ¡ÚPTC¡Û COMPANION DOCUMENT¡§Release 1.0, June 2018
MedDRA® POINTS TO CONSIDER COMPANION DOCUMENT has been considered as a part of ICH activities and this document version 1.0 was provided on June 2018.
It was developed and is maintained by a working group charged by the ICH Management Committee.
The working group consists of representatives of ICH regulatory and industry members, the World Health Organization, the MedDRA Maintenance and Support Services Organization (MSSO), and the Japanese Maintenance Organization (JMO) (see the M1 MedDRA Terminology page under Multidisciplinary Guidelines on the ICH website for a list of current members).

The purpose of this Companion Document is to supplement the Points to Consider (PtC) documents by providing additional details, examples, and guidance on specific MedDRA-related topics of global regulatory importance. The companion Document Release 1.0 consists of two chapters of ¡ÈData Quality¡É and ¡ÈMedication Errors¡É. And also, the companion Documents intended to be a ¡Èliving¡É document and is updated based on users¡Ç needs, rather than being tied to the biannual update of the PtC documents that is performed with each MedDRA release. Like the PtC documents, the Companion Document is available in English and Japanese; however, if certain examples are not relevant or are difficult to translate, these will not be included in the Japanese version.
Users are invited to contact the JMO Help Desk with any questions or comments about the MedDRA Points to Consider Companion Document.

And also, this PTC document is published on both website of MedDRA (http://www.ich.org/home.html) and ICH (https://www.meddra.org/how-to-use/support-documentation) at the same time.

¡¦ Release Announcement of MedDRA® POINTS TO CONSIDERCOMPANION DOCUMENT¡§Bilingual in Japanese and English¡¡(PDF)
¡¦MedDRA® POINTS TO CONSIDER COMPANION DOCUMENT¡§Japanese¡¡(MS-Word; docx) ¡¡(PDF¡Ë
¡¦MedDRA® POINTS TO CONSIDER COMPANION DOCUMENT¡§English¡¡(MS-Word; docx) ¡¡(PDF)

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¡ü ¡ÚRelated Documents¡Û MedDRA BEST PRACTICES DOCUMENT ¡Ê2018¡Ë
¡¦MedDRA® BEST PRACTICES ¡§Japanese (PDF)
¡¦MedDRA® BEST PRACTICES ¡§English (PDF)
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¡ü ¡ÚRelated Documents¡Û Unqualified Test Name Term List
Unqualified Test Name List is designed as an optional tool to avoid the current situation of user confusion between the terms that include Symptom, Sign, Disorder, Diagnosis, Indication, etc. and the investigational test name terms linked to SOC Investigations for the ESTRI of ICH E2B ICSR (Individual Case Safety Reports). MSSO provide the such a term list from the each MedDRA version, which isn¡Çt recommended for the use other than the data field of Test Name of ICH E2B.

JMO provide the description document of the list and its Japanese translation.

Description
Unqualified test name terms, e.g., PT Blood glucose, are intended for use only in the test name data element in data transmission standards and are not meant for use in other data fields capturing information such as adverse events/adverse reactions, medical history, or indications. The Unqualified Test Name Term List could be helpful to users in regulatory authorities and industry as a standardized query to check data quality by identifying the inappropriate use of unqualified test name terms in data fields other than the test name data element.

¡¦Description¡ÚEnglish¡Û¡ÊPDF)
¡¦Description¡ÚJapanese¡Û(PDF)
¡¦Unqualified Test Name Term List(MedDRA Ver.21.1)(xlsx)
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¡ü ¡ÚRelated Documents¡Û Patient-Friendly Term List
JMO provide Japanese translation documents of the description and the term list of ¡ÈPatient-Friendly Term List¡É provided by MSSO.

The Patient-Friendly Term List is a subset of MedDRA Lowest Level Terms (LLTs) that has been derived from the most frequently reported adverse events by patients and consumers.
The list include approximately 1,400 LLT terms and is maintained by the MSSO with each release of MedDRA beyond the version 20.1.

The intended purpose of the list is to facilitate direct patient reporting of adverse events to regulators and industry via mobile applications and web portals by allowing patients to select terms with which they would likely be familiar.
The Patient-Friendly Term List is incorporated in the Yellow Card online form for the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.

Note: The Yellow Card Scheme is vital in helping the MHRA monitor the safety of all healthcare products in the UK (https://yellowcard.mhra.gov.uk/).

¡¦ Description¡ÚEnglish and Japanese¡Û¡ÊPDF)
¡¦ Patient-Friendly Term List¡¡MedDRA Ver.21.1(xlsx)
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