In accordance with the directive issued by the Chairman of the Egyptian Drug Authority (EDA) dated August 13, 2025, the EDA announces the commencement of the unified registration file submission system (One Submission) for locally registered human pharmaceuticals (CTD) across all ministerial decisions, as follows:

Effective September 1, 2025:
- Companies may optionally submit products that have not yet been presented to any of the central departments of the EDA for technical study evaluation or analysis at the Central Administration for Pharmaceutical Control via the One Submission system.

Effective November 1, 2025:
- Submission of the unified registration file via the One Submission system becomes **mandatory** for all locally registered human pharmaceuticals (CTD).

Submission Conditions and Mechanism:
- The unified registration file must be submitted to the Regulatory Affairs Department for Human Pharmaceuticals at the General Administration for Registration, in accordance with the checklist published on the official EDA website.
- The Regulatory Affairs Department will forward the file to the relevant technical departments to initiate the technical evaluation and approval procedures.
- The company is required to conduct the analysis after receiving the registration notification, in accordance with the specifications approved by the Technical Affairs Department for Human Pharmaceuticals.
- The One Submission system does **not** apply to products that have already been submitted to any of the central departments of the EDA for technical study evaluation or analysis at the Central Administration for Pharmaceutical Control.