Professional Documents
Culture Documents
1. Egypt:
Capital:
Cairo
Population:
99.4 Million
Currency:
Egyptian Pound
Official Language:
Arabic official language, 2nd preferred language is English.
Healthcare Budget:
Healthcare spending
200
150
100
50
0
2014 2015 2016 2017
Healthcare spending
Market Growth:
Average growth of 26% last year.
FDA:
The Egyptian Drug Authority (EDA) is the pharmaceutical regulatory body of the
Egyptian MoH. The EDA has three suborganisations - the Central Administration of
Pharmaceutical Affairs (CAPA), the National Organization for Drug Control and
Research (NODCAR) and the National Organization for Research and Control of
Biologics (NORCB).
Registration Time:
Validity of Registration:
For medicinal products according to Ministry Decree 425/2015 the renewal process
should be done every 10 years. (48) For Biologicals, a renewal of the marketing
authorization is required every 5 years.
Registration Fees:
The approximate fees for marketing application form is EGP 10,000. The registration
fee is EGP 1000 for each “Application Form”; the fee is non-refundable.
Type of Dossier:
In Egypt, the submission dossier cannot be submitted as eCTD sequence. The
applicant has to submit the dossier as simple PDF documents.
Disease Burden:
1.A new proposal for advancing public health in 1. Elevated political and security risks will continue
Egypt, with a focus on healthcare insurance. to discourage investment in the short-term at
2. A growing number of free trade agreements and least.
increasing political will to develop the healthcare 2. Rapid and unchecked population growth could
sector. derail government's plans to improve healthcare
3. Proposals for a new Egyptian Drug Authority. insurance and provision.