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MedDRA, the importance of harmonisation

In a world that is more and more globalised, managing international issues was made easier by legal and procedural harmonisation in every field. Tools such technical harmonisation and mutual recognition agreements were actually very important to streamline and speed up the approval of medicines, manufacturing processes, reference standards.

At global level, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) represents a precious tool: in fact, the ICH gathers the regulatory authorities and pharmaceutical industries of several countries and organisations to discuss and harmonise technical and scientific aspects regarding human medicines, generating harmonised guidelines to be used as a reference point in all adhering countries.

Established by the European Commission, the US FDA and the Japanese regulatory agency, today the ICH counts 17 members and 32 observers, and also includes trade associations of the pharmaceutical industry (such as EFPIA, PhRMA and JPMA) and the regulatory authorities of Canada, Switzerland, Brazil, Singapore, Republic of Korea, China, Turkey and Taipei.
Its mission?

Achieving as greater harmonisation as possible all over the world to ensure safe, effective and high quality medicines, registered and maintained in the most resource-efficient manner without giving up high standards.

As of 1999, the ICH has produced several guidelines, harmonisation processes and standards, among which the standardised dictionary MedDRA is one of the most prominent.
MedDRA is an acronym of Medical Dictionary for Regulatory Activities. It is a rich and highly specialised collection of medical standardised terms, available in more languages to facilitate information exchange and to be used in the registration, documentation and monitoring of human medicinal products.

And product safety is just the sphere where the MedDRA dictionary is most widely known and used. It is in fact available in English, Japanese, Chines, Czech, Dutch, French, German, Hungarian, Italian, Korean, Portuguese, Brazilian Portuguese, Russian and Spanish. It is, therefore, a fast and flexible tool for safety information exchange between authorities (for which its use is free), and holders worldwide.

Every MedDRA term is in fact associated to a numeric code that remains unvaried in every updated version and is the point of reference based on which it is possible to track the exact translation of a given undesirable effect or a certain disease, thus ensuring accuracy and precision.

In order to meet the needs of the industry and regulatory authorities, continuously evolving due to scientific progresses and new health challenges, the dictionary is updated twice a year, with a new version released in March and a further revision available in September.

The consultation of the MedDRA dictionary allows holders of human medicines (including vaccines and biologicals) as well as regulatory authorities “to speak the same language” all over the world, so that when safety, efficacy and quality of medicines is at stake, there can be no misunderstanding that might put patient’s health at risk.

Written by: Maria Pia Felici

Foto di janeb13 da Pixabay