The Egyptian Drug Authority (EDA), represented by the General Administration for Stability, announces the release of the second edition of the updated requirements for variation files submitted directly to the General Administration for Stability. This update also includes specific requirements in cases where deviations occur in the storage conditions used during stability studies.

Requirement for Post-Approval Stability Studies Submission (Shelf-Life Extension / Change In-Use Study / Change in Stability Storage Conditions / Change in Short-Term Excursion Outside the Label Storage Conditions)

This update is part of the EDA’s ongoing efforts—through the Central Administration for Pharmaceutical Products—to facilitate procedures for company representatives, expedite the reception of supplementary stability study data, and accelerate the issuance of stability approvals for these products.

To view the service recipient notice, please click the link.