The new article is dedicated to the rapid alert system implemented by the authority in order to ensure the important safety-related information associated with healthcare products allowed for marketing and use in the country is communicated and shared without undue delay.
Table of content
The Egyptian Drug Authority (EDA), the country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to recalls for medical devices. The guidance provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance.
At the same time, provisions of the guidance are non-binding in their legal nature. Moreover, the authority reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Rapid Alert System
According to the guidance, the Rapid Alert System is designed to swiftly transmit urgent information when immediate action is required to protect public health by recalling or withdrawing medicinal products with quality defects or that are falsified. This system ensures that alerts are communicated without delay, reflecting the seriousness and urgency of the situation.
Criteria for Rapid Alert Notification
The urgency of removing defective medicinal products is classified based on the severity of the defect:
- Class I defects are potentially life-threatening, thus, rapid alert notifications for these defects must be sent to all contacts on the rapid alert notification list, regardless of whether the batch was exported to that country. The transmission of a Class I rapid alert must occur within 24 hours, with a maximum of 48 hours from the issuance of the recall letter.
- Notifications should state the severity of the defect and use the fastest communication modes, including email, telephone, fax, and SMS, to reach the entire supply chain.
- EDA can provide guidance to the recalling firm to ensure the product is promptly removed or corrected.
- Alerts can be communicated through various forms such as press releases, telephone calls, telegrams, telefaxes, mailgrams, or first-class letters.
- Notifications should be concise, clearly identifying the product(s) with details such as product name, size, brand name, serial number(s), potency, dosage, type, model, and batch number.
- Notifications should be sent in the most expeditious manner appropriate to the hazard of the product being recalled and, where appropriate, with proof of receipt (e.g., by certified mail).
- The licensee or representative must inform the concerned regulatory authority where the product batch(es) in question was distributed immediately after the recall decision. Further actions will be based on the recall class.
- Class II defects could cause illness or mistreatment but are not life-threatening. Rapid alert notifications for these defects should be sent to all contacts on the rapid alert notification list, especially if the distribution of the product batch is unclear. If distribution is known, notifications should be sent only to the relevant contacts. The transmission of a Class II rapid alert should occur within 72 hours whenever feasible.
- Class III defects do not pose a significant hazard to health. Notifications for these defects should be sent to all stakeholders within five days of the recall letter issuance.
- Falsified Products. For falsified products where an alert notice letter or public awareness letter has been issued, rapid alert notifications must be sent to all contacts on the rapid alert notification list within 24 hours, with a maximum of 72 hours of issuance.
Maintenance and Documentation
The scope of the guidance also covers various aspects related to the functioning of the Rapid Alert System including, inter alia, the following ones:
- The contact list for rapid alert notifications should be used for transmitting notifications falling within the scope of this procedure and the GMP non-compliance procedure. Messages should clearly identify the subject and specify if they are for information or action.
- All procedures should be documented and maintained up to date.
- Rapid alert contact lists for officials and companies should be regularly updated and verified (e.g., annually as part of GMP inspections).
- Staff involved in receiving reports of suspected defective products or handling rapid alerts should be trained in relevant procedures and have access to necessary forms and documents.
Criteria for Recall Letter/Rapid Alert Notice Publication
Under the general rule, upon the issuance of a recall letter or alert notice letter by the EDA, publication on the EDA website should occur based on the risk category involved:
- Class I Recall: Publication within 24 hours, with a maximum of 48 hours.
- Class II Recall: Publication within 72 hours.
- Class III Recall: Publication within five days.
- Alert Notice/Public Awareness Letter: Publication within 24 hours, with a maximum of 72 hours.
Intervals for Efficient Recall System
The recall process must be executed within specific timeframes based on the category of risk:
- Class I Recall: Maximum of 14 days.
- Class II Recall: Maximum of 21 days.
- Class III Recall: Maximum of 30 days.
It is also important to mention that the EDA reserves the right to adjust these timeframes based on the urgency and health risks involved.
Conclusion
In summary, the present EDA guidance explains the basic principles of the Rapid Alert System introduced in the country, emphasising the key points to be taken into consideration. In addition, the document also outlines the relevant timeframes the parties responsible for healthcare products placed on the market should comply with when it comes to notifications and alerts.
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