Introduction
The comprehensive legal framework governing the medical devices and pharmaceuticals sectors in Egypt ensures the safety, efficacy, and quality of products available in the market. This guide provides an overview of the key laws and regulations relevant to these industries, encompassing aspects such as registration, marketing, and compliance protocols.
Regulatory Authorities
The Egyptian Drug Authority, established under Law No. 127 of 1955, governs and regulates pharmaceuticals and medical devices to ensure compliance with both national and international safety standards.
Important Legislations
- Law No. 127 of 1955 serves as the foundational legal framework regulating the corporate operations involved in the manufacture, importation, and distribution of pharmaceuticals in Egypt. It mandates that all pharmaceutical products must be registered with the Egyptian Drug Authority (EDA) prior to being marketed or sold.
- Ministerial Decree No. 100 of 2017 outlines specific procedures for registering pharmaceuticals and medical devices. It clearly defines the documentation and compliance requirements that applicants must fulfill to obtain regulatory approval.
- Law No. 151 of 2019 establishes the legal criteria for defining and classifying medical devices. It also sets forth the conditions that manufacturers and importers must meet to access the Egyptian market.
- The Egyptian Drug Authority (EDA) enforces Good Manufacturing Practices (GMP) to ensure consistent production and quality control of pharmaceutical products in accordance with established standards. These standards apply throughout the manufacturing lifecycle to uphold product safety, efficacy, and reliability.
Registration Procedure
Pharmaceuticals
To market a pharmaceutical product in Egypt, the procedures that will be followed by companies are as follows:
- Application Submission: Application submitted to the EDA including product information, clinical data, and details of manufacture.
- Review period: Review by the EDA which may take to some months depending on complexity.
- Approval: If approved, obtain registration number which allows one to market that pharmaceutical product within Egypt.
Medical Devices
Registration process of medical devices includes:
Devices are classified according to the risk they pose (whether it being low, moderate, or high) and this determines the regulatory pathway. Technical documentation should be submitted to substantiate safety and efficacy. After review, if the device is conforming to all the regulatory requirements, the EDA would issue authorization to market.
Marketing and Advertising
Such strict regulation governs the marketing of pharmaceuticals and medical devices in Egypt. The code revised by the EDA has to be followed by the companies, which says:
- Advertising: Any advertising must be truthful and not misleading.
- Approval: All marketing materials should be approved by EDA before release.
- Restrictions: There may be further restrictions on the advertisement of certain products, especially those related to prescription drugs.
Post-Market Surveillance
Manufacturers must conduct post-market surveillance to ensure the safety and efficacy of their products after they enter the market. This comprises of:
- Adverse event reporting: Companies must report the adverse event to the EDA within the time frame specified.
- Periodic safety updates: Reports must regularly update any safety issue regarding the product with the EDA.
Conclusion
The pharmaceutical and medical devices regulations in Egypt constitute a strong legal framework to protect public health and advance innovation. Any company wishing to do business within this ever-changing market place needs to comply with EDA regulations. Keeping abreast of changes in regulations will be vital for sustaining success in this evolving sector.
This article offers a general overview of the subject matter and is not a substitute for legal advice. For guidance tailored to your specific circumstances, professional consultation is recommended.
If you choose us to support your specific issue, please do not hesitate to contact us using Inquiries Form (link) or by sending an email to coop@youssrysaleh.com.
