Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory Affairs in Egypt

Mohamed Amer (Abschlußjahr: 2020)

Summary
Language: Englisch
Egyptian health authorities have a quite old structured dividing system. The EDA is divided into 3 sub authorities, CAPA, NODCAR and NORCB who carry different responsibilities. CAPA is responsible for registering pharmaceutical products, issuing licenses for the establishment of pharmaceutical entities, and licensing the importation and exportation of pharmaceutical products. NODCAR works as a quality control authority responsible for ensuring the quality, safety, and effectiveness of pharmaceutical products, medicines, cosmetics and insecticides. NORCBs main function is to ensure the quality, safety and efficiency of all imported, exported and domestic biological products whether for human being use or for veterinary consumption. The submission process is quite complex and difficult to understand, especially for foreigner pharmaceutical companies willing to register medicinal products in Egypt. According to the latest information available on the internet until the date of writing this thesis, no digital submission portal is established for the EDA. CTD submission is possible though by handing in a CD. Variation Guidelines are well illustrated and are available to download on the EDA website. Furthermore, they are authored in English, which makes it more practical to use for all MAHs. Submission of Variation form can be conducted per email. Nevertheless, depending on the type and quantity of changes, a personal presentation of the MAH could be required.  
The biggest challenge for any foreign investor in Egypt remains the complex pricing system. Egypt has established a very strict pricing system, which forces MAHs of imported drugs to apply very low prices compared to the country of origin. In my opinion, that is one of the main reasons for the remarked medicine shortage in the last years.
Besides, the financial and commercial difficulties facing the country in the last years, like for example the devaluation of the local currency and the high inflation rate, which makes it even less attractive for pharmaceutical companies to enter the private market.
Nevertheless, special medicines like Oncology or Rare diseases drugs can enjoy the fast track evaluation. In some cases, even a special import permit can be granted without having a local registration. In this case, only an access to the private market is accepted.
The Egyptian authorities should work on initiating an easily accessible online database for all current regulations and guidelines to avoid confusion. Some of the old not any more valid guidelines are still on the website of the Egyptian Drug Authority (EDA), which leads to misunderstandings, especially for those who don’t speak Arabic. A part from that, an English translation is not available for all ministerial decrees.
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