Snapshot

The Biological Products Reliance Pathway (decree 343/2021) pathway has been developed by the of Egypt.

This pathway can be used where Biological products.

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 Norway Portugal Spain Sweden Switzerland United Kingdom United States

Reliance activities at EDA are applicant driven. Two approaches with different levels of reliance and different time frames are set according to the submitted documents as follows: 1. Level 1 (Abridged Registration / 30 days) - For products approved by EMA and/or FDA approval, with the submission of full assessment report and/or list of questions and answers in addition to CTD. 2. Level 2 (60 days) - In case of products with EMA and/or FDA approval with the submission of CTD only. PROCEDURE FOR SUBMISSION. 1. Submission of application: - An optional pre-submission technical support step, through the technical support administration, can be implemented to verify the submitted documents and guide the company to the most suitable registration pathway for the product in addition to determining the analysis requirements. - The applicant should submit the request inquiry through the relevant program and specify the desired pathway according to the attached documents uploaded (CPP, payment receipt, all data required to be filled in the program) - Request inquiry approval is issued in 5 working days from completion of documents uploaded on the program including the transfer to pricing administration within 30 days of approval issuance. - The applicant can request directly to submit the complete file to registration administration with proof of payment (after the submission of pricing file). - Upload all the annexed documents to be reviewed by all concerned administrations within the specified timeline. 2. Assessment of information received: - Evaluation of the submitted dossier and documents will be performed in compliance with the above-mentioned time frames on basis of verification of sameness and/or selective detailed review as deemed necessary by each unit / administration. - Any questions that may arise during the evaluation process will be addressed directly to the applicant and the reply should be submitted within specified timeframes. - In case of conditional approval of the product's registration by the reference agency, EDA may take the same decision as that of the reference agency and may also grant the product a conditional approval.