Riyadh: The Saudi Food and Drug Authority (SFDA) has been elected as a member of the Medical Dictionary for Regulatory Activities (MedDRA) Management Committee, marking a significant milestone in enhancing Saudi Arabia’s international presence and confirming global confidence in its competence within the pharmaceutical sector.

According to Saudi Press Agency, MedDRA is a widely recognized tool for documenting, registering, and monitoring the safety of pharmaceutical products both before and after authorization. This encompasses pharmaceutical preparations, biological products, vaccines, and combination products that integrate medicines with medical devices.

The election occurred in May during the meeting of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Management Committee, which was held in Madrid, Spain.

This appointment underscores the SFDA’s active role in ICH working groups, particularly in implementing the MedDRA dictionary and translating its terms into Arabic. The SFDA completed the review and Arabization of over 20,000 terms within a five-month period, from May to October 2022, supporting the dictionary’s use in pharmacovigilance.

Established by the ICH in the late 1990s, the MedDRA dictionary serves as a comprehensive reference for regulatory medical terminology. Initially designed to support pharmacovigilance activities and safety information, its use later expanded to facilitate the international exchange of regulatory data concerning pharmaceutical products.