The Egyptian Drug Authority (EDA) has announced a new mechanism to streamline the registration process and expedite import approvals for medical supplies, devices, and reagents. This initiative aims to enhance efficiency and support the medical industry in delivering critical products faster.
The new mechanism includes several key procedural updates. For companies listed on the white list, various easements have been introduced for registration and import approvals. Quality certificates that require communication will now be accepted based on correspondence from the European laboratory, provided that a commitment is made to address any discrepancies. Additionally, companies can now send their relationship documentation via official email, with the promise to submit certified originals within a specified period.
Trading certificates that do not mention the actual manufacturing site will be accepted if other quality certificates cover the actual manufacturer. Import approvals or notifications will be issued based on extended validity letters for CE certificates from reference countries. Procedures for issuing import approvals or registration notifications will proceed as long as the production is completed before the expiration of quality certificates.
Egyptian Drug Authority Implements New Changes to Streamline Registration and Committee Reviews
The General Administration for Registration has also implemented changes. Companies can now submit original safety commitment letters through express mail. Registration procedures will begin while verification of certificates covering manufacturers is ongoing. Samples required for registration will no longer need to be retained, and high-cost samples will only need to be presented to the scientific committee if requested, with CDs of the samples being sufficient.
Cases requiring scientific committee review have been divided into two groups. Some cases will no longer need to be presented to specialized scientific committees, such as those where the product has not been marketed in reference countries, has low sales during the reporting period, or has been marketed for less than three years. Conversely, cases involving more than 1% of incidents during the reporting period or any incidents related to the product will require committee review.
Egyptian Drug Authority Introduces Measures to Streamline Approval and Import of Medical Devices and Supplies
For medical devices and supplies, the Egyptian Drug Authority has introduced measures to facilitate their circulation. Import approvals will be granted for products even if one of the documents expires during the file review process, provided certain conditions are met. Medical devices that previously received conditional approval requiring re-evaluation will have their approvals renewed without re-presentation to the committee, given no imports occurred during the conditional period.
Additionally, new rules allow for the import of unregistered medical supplies and diagnostic reagents for urgent use, provided a registration file is submitted within six months. Companies with expired registration deadlines in the organizational guidelines will receive a six-month grace period for imports after paying the required fees.
These comprehensive updates by the Egyptian Drug Authority aim to streamline the approval and registration processes, ensuring timely access to vital medical products while maintaining high standards of safety and efficacy. This initiative reflects the Egyptian Drug Authority’s dedication to supporting the healthcare sector and improving patient care through efficient regulatory practices.
Resource: Egyptian Drug Authority, July, 2024
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