The UAE has consolidated pharmaceutical regulation under one federal body. According to the EDE, it was established on 29 September 2023 and is the federal authority responsible for regulating medical and pharmaceutical products, including medical devices, blood derivatives, stem cells, medicated cosmetics and veterinary medicines.
What this means in practice
Single federal regulator: marketing authorisations, establishment licensing and pharmacovigilance services sit with EDE, taking over functions previously handled by MOHAP.
Digital-first services: EDE services are accessed online, with UAE PASS used for authentication on several services.
Marketing authorisation validity: EDE's service page states that marketing authorisation certificates are issued for five years or for the validity it grants.
Pharmacovigilance officers: Marketing Authorisation Holders apply to EDE to approve and register their Qualified Person for Pharmacovigilance (QPPV).
What companies should do now
Confirm that company, manufacturer and product records are correctly reflected under EDE.
Review renewal dates and variation plans against current EDE procedures.
Verify the status of your local QPPV and pharmacovigilance system documentation.
Monitor EDE legislation and guideline updates, which are published on its portal.
How HERMS supports
HERMS acts as a regulatory partner for companies entering or operating in the UAE: company and manufacturer registration, dossier preparation, submission management, renewals and variations, and pharmacovigilance support.
Unsure how the EDE transition affects your portfolio? Request a portfolio status review from HERMS. Contact HERMS →
References
EDE – About Us: https://www.ede.gov.ae/en/home
EDE – Issuance of Marketing Authorization: https://www.ede.gov.ae/en/w/issuance-of-marketing-authorization-for-a-drug-or-biopharmaceutical-product
EDE – Approval of the Pharmacovigilance Officer: https://www.ede.gov.ae/nl/w/approval-of-pharmacovigilance-officer-within-uae