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EDA Guidance on Recalls: Initiation | RegDesk

The new article describes in detail how a recall action should be initiated, emphasizing the key points to be taken into consideration by the parties involved.

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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.

Initiation of Recall: Basics

The scope of the guidance covers, inter alia, the aspects related to the initiation of a recall intended to ensure the continuous safety of medical devices. As set forth under the applicable legislation, any batch of a product that does not meet specified quality standards must be withdrawn from the market.

The regulations further provide that recalls can be either voluntary or statutory, depending on the circumstances and the actions of the manufacturer or importer.

FDA Guidance on Distinguishing Medical Device Recalls from Enhancements: Key Concepts and Definitions

Voluntary Recall

Voluntary recalls are initiated by the manufacturer or importer of a medicinal product. The following information must be provided to the authority when requesting a voluntary recall:

  1. Product Details: This includes the product name (both generic and brand), dosage form, strength, batch or lot number, pack size, name and address of the manufacturer, manufacturing date, and expiry date of the recalled product.
  2. Reason for Recall: Detailed information about the defect or potential defect, the date, and circumstances of discovery.
  3. Distribution List: Information on the quantities produced or imported, the date distribution began, and a list of customers who received the product, including distribution dates.
  4. Recall Plan: A detailed plan and timeframe for the recall, proportional to the class of recall.
  5. Investigation Report: An investigation report detailing the causes of the defect and corrective and preventive actions undertaken.

The EDA will publish the voluntary recall on its website to notify the public after assessing the recall request’s risk. Manufacturers or importers must submit weekly progress reports during the recall and a final report after the recall’s completion, including reconciliation between delivered and recovered quantities.

If the manufacturer or importer does not comply with the recall plan, the EDA will mandate a statutory recall and take regulatory action if necessary.

Statutory Recall

A statutory recall is initiated by the drug authority under specific circumstances:

  1. Non-compliance with regulatory specifications found during post-marketing surveillance.
  2. Discovery of a defective batch during market complaint investigations.
  3. Negative quality impacts discovered during random conformity and validity investigations (e.g., potential contamination, mixing, deterioration).
  4. Unusual observations during visual inspections of retention samples indicating quality issues.
  5. Serious safety risks indicated by post-marketing monitoring or pharmacovigilance reports.
  6. Violations of laws, such as non-standard quality.
  7. Withdrawal of prohibited drugs.
  8. Promotional materials violating laws or errors in internal bulletins.
  9. Instructions from international bodies.

When evaluating a reported issue, the classification and level of recall action are determined following discussions among various EDA departments. The recall action level reflects the safety risk and distribution pattern of the product.

Factors Affecting Statutory Recall

Before initiating a recall action, certain factors must be considered to ensure that the findings are not influenced by external factors and to determine the necessity of the recall based on risk assessment.

Risk Assessment

As explained by the EDA, risk assessment includes the following considerations:

  1. Public Health Risk: The nature, extent, and urgency of the potential health risk.
  2. Likelihood of Occurrence: The probability of the issue occurring.
  3. Identification Capability: The ability of consumers, healthcare professionals, or caregivers to discover or identify the issue if it occurs.
  4. Specification Compliance: Whether the product meets approved specifications.
  5. Alternative Products: Availability of alternative products and the risks associated with not providing treatment if alternatives are unavailable.
  6. Correct Medication Risk: Risk of not receiving the correct medication.
  7. Short-Term and Long-Term Risk: Both immediate and long-term risks to consumers.
  8. Special Cases: For defective vaccines, a risk assessment should consider potential contamination and impact on national programs against viral diseases.

Further professional risk assessments should involve discussions with the manufacturer or importer and consider other related reports, distribution patterns, and stock levels.

On-Site Inspection

During routine investigations or in response to complaints, unusual observations may prompt consideration of a recall action. On-site inspections should address:

  1. Storage Conditions: Verify if incorrect storage could be the cause of the defect.
  2. Visual Inspection: Detailed description and identification of the defect, including whether it was found in new, previously unopened containers.
  3. Medical Devices: If the product is used with a medical device, check if the device could be the cause of the incident.
  4. Original Pack Comparison: Obtain an original pack for comparison with the suspected defective product.

Previous History

The concept of “previous history” includes previous reports from the manufacturing or importing site, comments on general GMP compliance, and information about related products manufactured or imported. On-site inspections may be required to assess batch records, plant records, and other potentially affected batches or products. Samples may be taken for further investigation, considering the quantity available and the tests required.

Conclusion

In summary, the present EDA guidance provides a detailed overview of the very first steps to be taken by the parties responsible for medical devices when initiating a recall. The authority emphasizes the importance of information related to the product in order to ensure the risks associated with the identified defects are duly mitigated.

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