The Healthcare Regulatory Framework in Egypt

Healthcare &
Life Sciences Focus

The Healthcare Regulatory Framework in Egypt

Rita Kevork
Associate,
Corporate Structuring

The healthcare regulatory framework is an essential component in the overall functioning and governance of the healthcare sector in Egypt. It sets out the guidelines, policies, and regulations that govern healthcare services, ensuring high-quality standards and patient safety. One of the key institutions responsible for healthcare regulation in Egypt is the Ministry of Health and Population (“MoHP”). The MoHP formulates and implements healthcare policies, regulations, and strategies to ensure proper planning, management, and delivery of healthcare services across the country. The MoHP oversees several bodies that play vital roles in healthcare regulation, such as the Egyptian Drug Authority (“EDA”), which oversees the registration, importation, circulation, quality control, and advertising of medical products and services.Generally, importers looking to import products into Egypt are required to be registered in the Importers’ Registry at the General Organization for Export and Import Control (“GOEIC”). However, in the case of importing healthcare related products, a license from the EDA is also necessary. The application process for such a license requires the submission of various documents, including: a certificate of pharmaceutical product for each product to be imported; a copy of the product registration certificate; and a copy of the manufacturing license of the foreign manufacturer. Once the license is obtained, importers must also comply with specific import regulations, including labelling requirements, packaging standards, and regulations for handling and storing the imported products. After the products are within the territory of Egypt, their advertisement and marketing is also subject to the prior approval of the EDA. The EDA reviews the content of the advertisement to ensure it complies with regulations and does not violate any laws in Egypt. Only registered medical products are eligible for advertising.

The EDA further has full supervisory authority concerning medical products, which includes the authority to inspect and investigate all activities relating to medicinal products along with the authority to request the disclosure of any information necessary for its inspections or investigations, regardless of its nature. In case of discovering violations, the EDA has the authority to impose penalties for violating its regulations, such as fines or withdrawal of products. Over the past couple of years, several various reforms have been introduced by the Egyptian government to improve the healthcare regulatory framework including the following: Universal Health Insurance Law no. 2 of the year 2018 (the “Universal Health Insurance Law”):
The Universal Health Insurance Law was first introduced in 2018 with the aim of providing universal coverage and granting access to Egyptians who had limited access to healthcare under the previous health insurance scheme. The Universal Health Insurance Law is expected to be progressively implemented across Egypt, with the aim of covering all Egyptian governorates by 2032.Digital Health Initiatives:
The Egyptian government has been investing in digital health initiatives to enhance the efficiency and effectiveness of healthcare services. This includes the development of electronic health records, telemedicine platforms, and mobile health applications.Health Facility Accreditation:
There has been a focus on improving the quality of healthcare facilities through accreditation programs. The MoHP has been actively working to ensure that hospitals and medical centres meet specific quality standards and adhere to best practices.While Egypt faces several challenges in the healthcare system, it is apparent that it is working relentlessly to enhance the healthcare regulatory framework, overcome the existing challenges, and ensure an inclusive and efficient healthcare system is in effect that prioritizes the health and welfare of all Egyptians.

For further information,
please contact Rita Kevork.

^{Published in January 2024}