Promoting Industrial Growth and Encouraging Foreign Direct Investment in Egypt
Pharmaceutical Industry
- The policy named the ‘Box’ , which regulates the registration of pharmaceuticals in Egypt, is abused by international pharmaceutical companies that hold the patents. These companies fill up a particular ‘Box’ with phantom products, thereby locking up the ‘Box’, and thus hinder effective competition of local companies, and limit the availability of affordable pharmaceuticals in the local market.
- Abolish the ‘Box’ system, and allow Egyptian companies to produce and register generic pharmaceutical products.
- Over the coming two years, complete the registration of all pharmaceutical products that are currently in the registration queue.
- In November 2018, Ministerial Decree No. 654 of 2018, concerning the registration of human pharmaceuticals, was issued. It stipulated that under certain conditions, biosimilars registration applications, which exceed the number of pharmaceuticals allotted to a biosimilar ‘box’ (referenced in Ministerial Decree No. 425 of 2015) will be accepted. Specifically, applications will be accepted for pharmaceuticals listed as in short supply and with no substitute, during the year preceding the issuance of the Decree, or in other cases determined by the Central Administration for Pharmaceuticals Affairs, according to market needs.