Note: This blog post was originally written in Japanese for our Japanese website. We used our machine translation platforms to translate it and post-edit the content in English. The original Japanese post can be found here.
MedDRA is a terminology that is used when translating documents related to pharmaceuticals and medical devices. MedDRA is an essential topic for translators and reviewers in the medical field, so we will introduce it from the perspective of a translation company for those who are just starting out in medical translation.
What is MedDRA?
MedDRA is an abbreviation for Medical Dictionary for Regulatory Activities (developed by ICH*), and is a glossary of terms that is particularly necessary when applying for approval of drugs and medical devices, and when evaluating and exchanging safety information. It is used by regulatory authorities and companies in many countries at both the pre-marketing and post-marketing stages.
It is based on English and includes symptoms, signs, and disease names. It is also available in languages other than English, and the English-Japanese version is called MedDRA/J.
*ICH = The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Intended use of MedDRA
First of all, before drugs and medical devices are sold to the public, multiple tests are conducted over a long period of time, usually about 10 years. Even after the product is sold, safety information (side effects, malfunctions, etc.) is collected. If the terminology used during this process is not consistent, serious side effects may be overlooked, and it may also be complicated to share information from tests conducted overseas.
For example, during the development of a certain drug, a person taking part in the clinical trial* may report being bitten by a dog. This may not seem to have any medical relevance, but what if 99 out of 100 people taking part in the clinical trial had been bitten by dogs? Wouldn't it seem as if the drug has something to do with the trial participants being bitten by dogs?
In such cases, if there is no consistency in the words used in the reports, such as "bitten by a pet," "injured by an animal," "snapped at by a Chihuahua," each incident will be stored in the data as a separate event, and the fact that a large number of people had actually been bitten by dogs will not be apparent.
So, it's important to use consistent terminology, which is where MedDRA comes in. For this example, "Dog bite" is listed in MedDRA version 26.0 as a Lowest Level Term (LLT).
Any malfunction or problem that occurs during clinical trials or after the product is released on the market is reported to the government as an adverse event, even if the event appears to be unrelated to the drug or medical device used, and the data is accumulated.
*Clinical trials = Tests to confirm the effectiveness (safety and efficacy) of drugs and medical devices by actually using them on people in order to obtain government approval for their manufacture and sale.
How to use MedDRA
MedDRA is basically a paid service. In Japan, registration as a member of JMO (the organization that manages MedDRA) is required to use it. You cannot check it unless you register, and you cannot view it by searching on Google, etc.
Because MedDRA is essential for proper translation services, medical translation companies are often registered as members. If you are a freelance translator or reviewer and would like to use this service, consult with the translation company you work with regarding how to use it.
Main Features of MedDRA
There are several features, such as the use of Japanese synonyms* and SMQs (Standard MedDRA Queries), but we will introduce the most basic features here.
*Synonyms are different Japanese spellings (synonymous Japanese terms for one English term) that are organized to be associated with the corresponding MedDRA English spelling term.
Version
In principle, it is updated twice a year, so there are multiple versions. As of March 2024, the latest version is 26.1.
Since all kinds of health problems are reported as adverse events, including those with an unclear causal relationship to the drugs or medical devices used, terms are added and revised. Depending on the version, the same content may be expressed differently, so be sure to check which version to use.
Hierarchy
Because it contains a huge number of terms, it is stratified or grouped into five groups, as follows, in descending order from the uppermost hierarchy:
| SOC (System Organ Class) HLGT (High Level Group Terms) HT (High Level Terms) PT (Preferred Terms, Basic Terms) LLT (Lowest Level Terms) |
LLT, at the lowest level, belongs to PT, then PT belongs to HT, and so on. SOC is the broadest classification. For example, the common symptom "pyrexia" is included in the following PT and LLT.
| Hierarchy | Term |
| SOC | General disorders and administration site conditions |
| HLGT | Body temperature conditions |
| HTL | Febrile disorders |
| PT | Pyrexia |
| LLT | Pyrexia |
Since LLT is the most detailed classification, it may seem best to use LLT for reporting, however, the data specifications to be used for side effect reports are dictated by regulations, so it’s best to check which hierarchy to use for each case.
Currency
When searching for a term in MedDRA, you may find that multiple English words come up for one Japanese word.
Example:
- 発熱/Pyrexia
- 発熱/Fever
When using LLT terms, the currency flag (current or non-current) for each term is indicated as either N or Y. Y (current) terms are to be used unless otherwise specified.
Those with N (non-current) are not deleted for convenience but are generally not used because they are misspelled or outdated. Currency is written at the bottom of the LLT details on MedDRA, so please check carefully.
Summary
Proper use of MedDRA is essential in medical translation. However, depending on the type of document, the use of MedDRA may not be required. To avoid unknowingly making translation errors, translators should check with the translation company about the use of MedDRA before starting the translation.
Kawamura's medical translation services
Kawamura International excels at human translation through collaboration between professional linguists. For medical translation projects in particular, we have a specialized team that includes medical advisors. We also support translations from one language into multiple languages in a project.
Furthermore, our translation services include combination of machine translation and post-editing (revising the machine translation output), allowing us to propose optimal solutions to meet your quality and deadline requirements.
We achieve stable quality for both short-term and long-term projects with quality assurance based on statistical quality control methods. We are also certified with ISO17100, the international standard for translation services, and ISO27001 (ISMS certification), the international standard for information security. Feel free to reach out to us if you're looking for medical translation services.
