The Disruption Series: MedDRA Now Impacted By Coronavirus

This is the ninth piece in the Lionbridge Disruption Series, a collection of commentary from life sciences experts on how the industry is changing as a result of the COVID-19 crisis.

Coronavirus now has such influence that multinational bodies are changing their reporting systems to create standardized MedDRA terms. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) announced on April 1 the availability of new MedDRA terms on the MSSO’s website for coding and reporting related to coronavirus.

The MedDRA (Medical Dictionary for Regulatory Activities) offers a single standardized and internationally harmonized medical terminology. Researchers, healthcare workers and governments use it for regulatory communication and data evaluation on human medicinal drugs. The official planned release of the next MedDRA, Version 23.1, is in September 2020.

MedDRA terminology is applicable throughout the life cycle of a medicinal product. This includes during clinical trials, regulatory drug registration and safety monitoring in post-marketing phase.

At the time of the ICH announcement, corona-related terms were available in English only but will be made available in all languages shortly. The current languages in the scope of the medical dictionary include Chinese, Czech, Dutch, French, German, Hungarian, Italian, Japanese, Korean, Portuguese, Brazilian Portuguese, Russian and Spanish.

Having a multilingual medical terminology database facilitates accurate data sharing across regulatory territories and analysis of medical events using a hierarchical structure.

Lionbridge Supports all MedDRA Languages and More

As a language service provider, the adoption of MedDRA terminology into the language technology stack is immediate for Lionbridge. We are dedicated to supporting clients in obtaining consistent and accurate terminology across all languages and phases of the drug life cycle.

Use of MedDRA standards for regulated content related to human medicines enables not only optimization of communication and regulatory processes. It also facilitates easy international exchange of data; cross references and analysis without distortion of data. In the case of a pandemic, international exchange of knowledge is key to reducing the impact of a disease around the world.

Lionbridge can apply MedDRA terminology to all regulated content throughout the life cycle of your medicinal products. This includes translations related to multinational clinical trials, drug dossier submissions under M4 CTD standards and safety reporting.

Our Lionbridge Life Sciences team is working around the clock to help our customers minimize business impact of the pandemic—and to stop the pandemic itself. Reach out to see how we can help.