The Saudi Food and Drug Authority (SFDA) has been elected to the Management Committee of the Medical Dictionary for Regulatory Activities (MedDRA), reinforcing Saudi Arabia’s global standing in the pharmaceutical industry and reflecting international confidence in its regulatory expertise.
MedDRA is an internationally recognized system used to document, register, and monitor the safety of pharmaceutical products throughout their lifecycle. This includes medicines, biologicals, vaccines, and combination products involving both drugs and medical devices.
The election took place in May during a meeting of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Management Committee, held in Madrid, Spain.
SFDA’s selection highlights its significant contributions to ICH initiatives—particularly in implementing and translating MedDRA terminology into Arabic. From May to October 2022, the SFDA successfully reviewed and translated more than 20,000 MedDRA terms, enhancing the dictionary’s accessibility for Arabic-speaking regulatory and healthcare professionals and supporting pharmacovigilance efforts.
Originally developed by the ICH in the late 1990s, MedDRA has become a vital tool for regulatory communication. While it was initially intended to support drug safety monitoring, its role has expanded to promote the global exchange of pharmaceutical regulatory information.
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