A national body to oversee the safety of pharmaceuticals, the Egyptian Drug Authority (EDA), was created in 2019. However, the following requirements pose obstacles for manufactures:

• The requirement that manufacturers obtain an import approval for each consignment of imported raw materials; the additional fees associated with this requirement result in raising the price of the final.
• The extreme processing delays in obtaining certificates of Free Sale and certificates of GMP negatively affects the exportation of products.
• The Central Administration for Pharmaceutical Affairs refuses to accept the trading certificates for non-sterile products, which are issued by the IDA and sent by express mail.
• Exporters must fulfill additional requirements to be able to export their products, including a commitment to provide production materials for a period of 6 months; receiving visits for verification; and obtaining the approval of the Public Authority for Unified Procurement.

• Abolish the requirement that manufactures obtain an import approval for each consignment of imported raw materials.
• Expedite the issuance of the certificates of Free Sale and the certificates of GMP.
• Refrain from issuing any new export requirements without consulting with exporters.

• On August 25, 2019, the President ratified Law No. 151 of 2019; Article 14 established the Egyptian Drug Authority (EDA), and Article 16 specified its mandate. According to Article 14, “A public service authority, called the Egyptian Drug Authority, is created; it has a juridical personality and is affiliated with the Prime Minister; the location of its headquarters is to be determined by the Prime Minister, and the board of directors may decide to open additional locations.” 
• Article 16 stipulates that “The new Authority aims to organize, implement, and control the quality, effectiveness, and safety of the medical preparations and devices provided for in the provisions of this Law.  It is also tasked with enforcing the  provisions of  the current law governing the practice of pharmacy, provided that they do not contravene any of the provisions of this law. To accomplish this, it shall also assume all the necessary powers, functions and legal actions.”