Snapshot

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

This pathway can be used where unlicensed biological 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

PRE-SUBMISSION ACTIVITIES: If considered necessary or desirable by the applicant and EDA, scientific advice request may be performed and a discussion may be held before the actual evaluation process starts. SUBMISSION OF APPLICATIONS: The applicant must submit an application letter to EDA Registration directorate. The application letter should include details of country and sites of manufacture, as well as the presentations proposed for the product. ASSESSMENT OF INFORMATION RECEIVED: Once the product has been considered eligible for assessment under the EUA procedure, a product evaluation team is established within 2 WD. The product evaluation team will perform the screening of the submission to ensure that sufficient information is available to initiate the assessment based on the essential data requirements within 7 WD. Rolling submissions procedure is followed for evaluation of data & EDA requirements / reports are continuously sent to applicants as an outcome for each roll, rolling evaluation is performed within 20 WD. In practice, where there is an urgent public health need, assessment timelines will be reduced to the absolute minimum. Applicants should promptly submit any additional information on the development of the product to EDA particularly if it may affect the product’s benefit/risk assessment. REQUIREMENTS FOR BATCH RELEASE: Each lot of biological products is subjected to lot release procedure before marketing in Egypt by EDA through applying risk based approach. The assessment and testing of biologicals is based on the degree of risk associated with the product. There are technical and logistic issues for pandemic emergency which could affect the EDA lot release policy for biologicals. Biological products received for batch release in Egypt should be produced in compliance with GMP and tested for quality and safety by the manufacturer. For emergency situations, first priority in lot release procedures should be given to review of the manufacturer’s protocol and should always be part of the lot release by EDA. Protocol review: A summary protocol should be submitted to the EDA. It should be complying with the national and international regulations, as well as literature to support scientific consensus on aspects related to the specific type of product. Sample testing: In case of emergency, biological product could be released into the market after performing the minimum testing items that assure safety and quality of the product based on risk assessment in accordance to each product type and laboratories capabilities. ASSESSMENT AND ISSUANCE OF EUA: The product evaluation team prepares a technical assessment report for submission to the emergency committee who will give the recommendation regarding issuing EUA for the product submitted. The conditional time-limited EUA is issued from the relevant Central Administration after the recommendation of EDA chairman deputy recommendation and endorsement of EDA chairman.