The article highlights the key points related to the regulatory framework for recalls introduced in Egypt.
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.
Introduction
Recalls are actions undertaken to remove or withdraw a drug from distribution or use due to reported deficiencies in quality, efficacy, or safety. These quality-related defects can include substandard, adulterated, or counterfeit medicinal products.
Recalls related to safety and efficacy encompass serious adverse reactions. Additionally, recalls cover medicinal products banned under the Pharmacy Profession Law, as well as products with suspended or revoked licenses.
This recall process applies universally to pharmaceuticals, including medicines, biological preparations, cosmetics, and medical supplies. As explained in the guidance, the rapid alert system is designed for scenarios where the urgency and seriousness of warnings do not allow for any delay.
The system requires an assessment of the defect’s severity and its potential harm to patients.
Regulatory Background
Under Law 151 of 2019, the Egyptian Drug Authority was established to regulate, implement, and supervise the quality, efficacy, and safety of medical products. The EDA oversees the production, circulation, and quality verification of medical products and devices, including raw materials, within and outside Egypt.
The EDA sets the rules and procedures for the import, export, registration, pricing, circulation, supervision, and inspection of medical products and devices. These processes are coordinated with relevant entities and aligned with international standards to ensure the integrity of Egyptian products domestically and internationally.
Recommendations provided in the present guidance apply to all reports of defective product quality and safety and efficacy incidents for all medications, including vaccines and biologics. They are intended for licensees such as manufacturers, importers, agents, distributors, and retailers.
Other agencies may apply this guideline if urgent action is required to protect public or animal health. The guideline provides stepwise actions for recall strategies, helping to assess recalls at each level and ensure compliance with the established timeframe.
This guideline primarily applies to distributed and marketed batches. In cases where non-conforming batches have not been marketed, there is no need to issue a recall.
Definitions
In order to assist the parties involved with interpreting the relevant regulatory provisions and requirements set forth therein, the document provides definitions of the key terms and concepts used in the context of recalls, including:
- Recall: The removal of marketed products due to a lack of quality, safety, or efficacy, including labeling violations.
- Batch Recall: The process of removing specific lot(s) from the market found to be defective and posing health risks.
- Batch: A specific amount of material produced in a process expected to be homogeneous within certain limits.
- Customer: Any person, institution, or entity purchasing or receiving goods from the company for storage, distribution, and sale.
- Substandard Medical Products: Authorized medical products that fail to meet quality standards or specifications.
- Falsified Medical Products: Products that deliberately misrepresent their identity, composition, or source.
Types of Recalls
In accordance with the existing regulatory framework, recalls are divided into two categories:
- Voluntary Recall: Initiated by a licensee due to quality issues identified during periodic reviews, market complaints, or other failures.
- Statutory Recall: Directed by drug control authorities after verifying a product’s violation of laws.
Documents and Notifications
The guidance also outlines the scope of general documentation pertaining to a recall. Under the general rule, it includes:
- Recall Letter: Issued by the EDA, it announces the withdrawal of marketed products due to lack of quality, safety, or efficacy, including labeling violations, directed to stakeholders and the public.
- Alert Notice Letter: Issued by the EDA to alert stakeholders and the public about the presence of counterfeit products.
- Public Awareness Letter: Notification published on the EDA website informing the public about the possible presence of substandard/falsified products.
Rapid Alert System
As explained by the EDA, the rapid alert system involves procedures for promptly notifying licensees, manufacturers, stakeholders, relevant organizations, and the public about the issuance of recall or rapid alert notice letters for substandard or falsified products that could impact public health.
The system uses a rapid alert contact list, which includes contact details such as telephone and fax numbers, and email addresses, and is used to notify relevant parties in case of a detected substandard or falsified product.
Waste Management
The guidance also outlines specific rules related to waste management.
- Cytotoxic Waste: Contains substances with genotoxic properties, including cytotoxic drugs.
- Infectious Waste: Includes all types of waste containing pathogenic microorganisms, such as live attenuated vaccines.
- Non-hazardous or General Waste: Waste that poses no particular biological, chemical, radioactive, or physical hazard. This category includes all expired pharmaceuticals, unsealed syrups or eye drops, cold chain-damaged pharmaceuticals, bulk or loose tablets and capsules (unless sealed and properly labeled), and all recalled and substandard/falsified products.
Conclusion
In summary, the present guidance document issued by the EDA provides a comprehensive overview of the regulatory requirements in the sphere of recalls to be initiated with respect to medical products in order to ensure public safety and health protection. The document outlines the key points to be taken into consideration by manufacturers and other parts involved as set forth under the existing legal framework.
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