It was released just few hours ago the news of an update of 23.0 MedDRA dictionary version. The Coronavirus (COVID-19) pandemic has prompted an urgent need for a harmonized and standardized approach for the coding and reporting of infection as a global health issue.
Although initially it was thought to introduce the new terms related to Coronavirus in the next version of the MedDRA dictionary, the 23.1, a few hours ago the ICH M1 Points to Consider Working Group and the MSSO MedDRA with the approval of the MedDRA management, decided to implement them immediately in the version 23.0, already released in March and mandatory from 4th May 2020. This is in fact currently being updated and it will be available on 19th April 2020.
New PT terms will include: PT COVID-19, PT SARS-CoV-2 test, PT SARS-CoV-2 positive test, PT SARS-CoV-2 negative test and others still being updated such as PT SARS-CoV -2 immunization, PT COVID-19 treatment, PT COVID-19 prophylaxis, PT Exposure to SARS CoV-2, PT Suspected COVID19..
An exceptional but indispensable act: “the COVID-19 pandemic is demanding flexible approaches to ensure that any scientific and medical information from COVID-19 outbreak can be captured, shared and analysed appropriately”, this is what is reported in the official communication.
MedDRA users are therefore encouraged to implement this new version within the set deadline and to put hold any activity that could be affected by this change.