Snapshot

The Emergency Use Application & Approval (EUA) - Medicinal Products pathway has been developed by the of Egypt.

This pathway can be used where unlicensed medicinal products for use during public health emergency cases..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Australia Austria Belgium Canada Denmark Finland France Germany Iceland Ireland Italy Japan Luxembourg Netherlands New Zealand Norway Portugal Spain Sweden Switzerland United Kingdom United States WHO

In case of emergency, it is permissible to grant MA for any pharmaceutical product, with the exception of some conditions once the generic has been considered eligible for EUA procedure. PRE-SUBMISSION ACTIVITIES: Once the product has been considered eligible for assessment under the EUA procedure based on the eligibility criteria previously mentioned, a detailed technical report is prepared by the Central Administration for Pharmaceutical Products supported by scientific evidences, scientific committee advice (if considered necessary) and market studies to be presented to the EDA Chairman to be approved for permitting the registration requests. EDA should announce the permission of accepting registration requests for those generics on EDA website and start receiving requests from the applicants. SUBMISSION OF APPLICATIONS: EDA requirements should be submitted according to the submission guidance and checklists for each relevant unit taking into consideration the exceptions mentioned in this guideline. EDA will receive and evaluate the submissions to ensure that sufficient information is available to initiate the assessment based on the essential data requirements so that the applicant could get initial approval with 3 months’ validity that could be renewed once (if exceeded this timeline, the applicant should complete the registration process according to the registration normal track) to proceed to the manufacturing process of the drug product to complete its registration file and to grant an EUA. The applicant should submit the following documents for evaluation by EDA to grant a preliminary quality module approval which is a mandatory approval for proceeding to the manufacturing process: specifications & certificate of analysis for the drug substance; composition of the drug product; specifications of the drug product.; and the container closure system of the drug product.