Welcome to MedDRA/ J
MedDRA/J & MedDRA
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) developed MedDRA, a rich and highly specific standardised medical terminology to facilitate sharing of regulatory information internationally for medical products used by humans. ICH’s powerful tool, MedDRA is available to all for use in the registration, documentation and safety monitoring of medical products both before and after a product has been authorised for sale. Products covered by the scope of MedDRA include pharmaceuticals, biologics, vaccines and drug-device combination products. Currently, its growing use worldwide by regulatory authorities, pharmaceutical companies, clinical research organisations and health care professionals allows better global protection of patient health. ICH has created a governance structure to nurture and protect the integrity of MedDRA. The ICH MedDRA Management Committee has overall responsibility for the direction of MedDRA, and oversees all the activities of the ICH MedDRA Maintenance and Support Services Organization (MSSO) which is tasked to maintain, develop and distribute MedDRA. ICH has also established a Japanese Maintenance Organization (JMO), which works in close collaboration with MSSO, to support users in Japan. The activities of JMO are limited to maintain the Japanese version of MedDRA (MedDRA/J) and to distribute and support companies in Japan. Companies whose locations are outside of Japan can purchase the Japanese version of MedDRA from the MSSO.
MSSO & JMO
The MSSO - Maintenance and Support Services Organization - serves as the repository, maintainer, and distributor of MedDRA as well as the source for the most up-to-date information regarding MedDRA and its application within the biopharmaceutical industry and regulators. MedDRA subscribers submit proposed changes to the terminology. The MSSO includes a group of internationally based physicians who review all proposed subscriber changes and provide a timely response directly to the requesting subscriber.
Please visit the MSSO website (http//www.meddra.org) or contact the MSSO Help desk (email@example.com).
JMO - Japanese Maintenance Organization - is a partner of the MSSO. JMO provides MedDRA support to companies headquartered in Japan as well as maintaining and distributing MedDRA/J. The JMO assists the MSSO in providing MedDRA-related information and services in Japan.
The responsibilities of the JMO are to maintain MedDRA in the Japanese language (MedDRA/J) synchronized with the English version, and to distribute and to promote the standardized utilization in Japan.
If you have any question regarding MedDRA Japanese version or MedDRA utilization in Japan, please do not hesitate to contact the JMO.
- 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.
- 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.
- 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.
- 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 ‘uniqueness’ and that lack of uniqueness could lead to misunderstanding or confusion by the user. Just as users of English MedDRA require term ‘uniqueness’, so too do MedDRA/J users for Japanese terms.
Until 2012, Japanese regulations, in principle, recommended that Japanese domestic cases use "Japanese current MedDRA terms", and foreign cases only required "English current MedDRA terms". However, after 2013, “English current MedDRA terms" are required based on the 2013 Japanese notice, for all ICSRs both domestically and internationally.
- 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 ‘most appropriate’ among them is flagged as current in MedDRA/J; all other LLTs are flagged as non-current. To determine the ‘most appropriate’ 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’s Illustrated Medical Dictionary and Stedman’s 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 ‘adjective + noun’ has preference over that of ‘noun + adjective’.
- -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.
How To Contact Us
JMO（MedDRA Japanese Maintenance Organization）
Pharmaceutical and Medical Device Regulatory Science Society of Japan
Nagai Kinenkan 3F 2-12-15 Shibuya, Shibuya-ku, Tokyo, 150-0002 JAPANContact form