Registration timelines decide when a product reaches patients. This page collects the official review targets published by six regulators, with a link to each source. Each target is as stated by the regulator at the linked source.
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Official registration timelines
- Saudi Arabia (SFDA): Verification pathway 30 working days; Abridged pathway 60 working days, counted from the date the Drug Sector approves the requested pathway. Official source
- UAE (MOHAP): Registration of a conventional pharmaceutical product takes 45 working days; certificates are valid for five years. Official source
- UAE (Emirates Drug Establishment): Marketing authorization for a drug or biopharmaceutical product takes 45 working days. Official source
- Egypt (EDA): Track A products are registered within one month and Track B within two months of receiving the complete dossier. Official source
- European Union (EMA): Evaluation takes up to 210 days; the European Commission decides within 67 days of the CHMP opinion. Official source
- United States (FDA): Review goal of 10 months for standard and 6 months for priority applications. Official source
Related guides
- SFDA Verification and Abridged pathways
- Pharmaceutical product registration in the UAE
- GCC central registration (GCC-DR)
- Medical device registration in the GCC
How HERMS supports
HERMS Consultancy DMCC, Dubai, supports healthcare and life sciences organisations across the product lifecycle, from regulatory and market access to marketing, supply, pharmacovigilance, compliance and quality. Contact HERMS.