Regulatory supervision of Egypt’s medical supplies sector continues to shape market dynamics and manufacturing practices across the country. Under the mandate of the Egyptian Drug Authority (EDA), contract manufacturing also known as toll manufacturing has emerged as a key model in ensuring product quality, supply continuity, and industrial efficiency.

Scope of Application

The new regulatory framework applies to any company involved in producing medical supplies through licensed third-party facilities. Both the manufacturing entity and the contracting party placing the product on the market are accountable, ensuring that regulatory responsibility remains intact even when production is outsourced.

By extending oversight into contractual arrangements, the EDA reinforces the principle that public health responsibility travels with the product throughout the manufacturing process, whether production occurs in-house or at a third-party facility. The approach aligns with global standards, which treat contract manufacturing as an integral part of regulated medical production rather than a peripheral business arrangement.

Registration Requirements

Companies planning to engage in contract manufacturing of medical supplies in Egypt must comply with a set of clear registration and approval requirements. These measures aim to ensure product quality, traceability, and accountability across the supply chain, while integrating contract manufacturers into the formal regulatory framework.

1. Pre-registration with the Egyptian Drug Authority (EDA)

Before beginning any production, companies are required to submit a registration application to the EDA The application typically includes company details, information about the product owner, a description of the intended manufacturing activities, and contact information for compliance officers. Early registration allows the authority to maintain oversight from the start and ensures that responsibilities are clearly defined.

2. Verification of Facility Licenses and GMP Compliance

Production must take place in a facility licensed by the EDA and fully compliant with Good Manufacturing Practices (GMP). Verification generally involves reviewing licenses and certifications, conducting on-site inspections to confirm production and storage capabilities, and examining quality control records. This step ensures that all manufacturing processes adhere to legal standards for safety and quality.

3. Submission of Product and Production Scope

Companies are required to outline product specifications, the stages of production undertaken by the contracted facility, and the division of responsibilities between the product owner and the manufacturer. This prevents ambiguity over accountability and facilitates effective regulatory monitoring.

4. Compliance with Storage and Distribution Requirements

Products must be stored in accordance with approved conditions, including adequate space, temperature and humidity control, and measures to prevent contamination or damage. Maintaining these standards ensures product quality after manufacturing and protects public health.

5. Prior Approval for Operational or Contractual Changes

Any changes to the manufacturing process, including switching facilities, altering the production scope, or modifying contracts, must receive prior approval from the EDA. This ensures ongoing regulatory compliance and prevents circumvention of established rules.

Conclusion

The new contract manufacturing regulations strengthen legal compliance, ensure product quality, and promote transparency across the supply chain. By clearly defining responsibilities and registration requirements, the framework not only safeguards public health but also provides a predictable and stable environment for manufacturers and investors in Egypt’s medical supplies sector.

Authored by our Junior Associate, Nahla Mohsen