1.

Egypt:
Capital:
Cairo

Egypt, regularity and richness of the annual Nile River

flood, coupled with semi-isolation provided by deserts to
the east and west, allowed for the development of one of
the world's great civilizations. The region's most
populous nation, also boasts a pharma market on the up,
growing gradually with a high rate.

Population:
99.4 Million

Currency:
Egyptian Pound

Exchange Value in USD:       

1000 Egyptian Pound equivalent to 63.69 USD

Official Language:
Arabic official language, 2nd preferred language is English.

Destination Sea Port or Airport:   

Egypt has 15 ports, major Port is Alexandria. Alexandria Port, controlled by
the Alexandria Port Authority, is the country's largest and it handles approximately
55% of Egypt's international trade.

International Borders/Surrounding Countries:

Egypt is a country in northeastern Africa and southwestern Asia.
North - Mediterranean Sea
West - Libya
East – Palestine, Israel and Red Sea
South - Sudan
Egypt shares maritime borders with 9 countries.

Pharma Market Value:

Egypt pharma market is valued $3.8Bn with a growth rate of 26% over last MAT.
Alimentary and Anti-infectives are the top selling TAs together accounting for 36%
sales of the total market.
Novartis is the leading corporation with $301Mn sales in 2018 while Nestle (b. $27M)
is the fastest growing corporation, growing at 131% PPG over last MAT.
Market Share:

Top 20 Pharma Companies:

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.

Name of Tender Body:

Indian Pharma Companies:

On February 21, 2017, Sun Pharma opened its manufacturing unit in Cairo.

Characteristics of the market:

 Steadily growing population
 Increasing penetration (57%) of insurance
 Increasing aging population
 Growing healthcare awareness
 Growing demand for prescription medicine
  Encouragement by government to private sector to take lead role in providing
healthcare services.
 Decreasing fertility rate

Disease Burden:

Selected Adult Risk Factor Trends:

Top therapy areas:

Causes of Death and Disability compared with other locations:

Disease trend and Risk factors:

SWOT:

1.Well established manufacturing industry
comprised of both state-owned and privately
owned pharma companies.
2. Low labour cost and highly skilled doctors,
pharmacists, technicians and engineers.
1.A new proposal for advancing public health in
Egypt, with a focus on healthcare insurance.
2. A growing number of free trade agreements and
increasing political will to develop the healthcare
sector.
3. Proposals for a new Egyptian Drug Authority.
1. Strict pricing controls and reference pricing
system reduces innovative drugmaker potential
earnings.
2. Challenging regulatory regime for foreign firms.
Patent laws remain notably below international
standards, with data protection and enforcement
being major concerns.
1. Elevated political and security risks will continue
to discourage investment in the short-term at
least.
2. Rapid and unchecked population growth could
derail government's plans to improve healthcare
insurance and provision.