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pharmaceutical industry in Egypt.pdf

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Sectoral Survey Pharmaceutical Industry in Egypt November 2010 Sectoral survey: Pharmaceutical Industry 2 I ndex Page 1. Introduction 3 2. Definition 4 3. Regulatory framework 4 3.1.Regulatory body 3.2.Pricing 3.3.TRIPS 4. Market analysis 7 4.1.Market structure 4.2.Consumption 4.3.Production 4.4.Key players
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    Sectoral Survey  Pharmaceutical Industry in Egypt November 2010    Sectoral survey: Pharmaceutical Industry    2 Index    Page    1.   Introduction 3 2.   Definition 4 3.   Regulatory framework 4  3.1. Regulatory body 3.2. Pricing   3.3.TRIPS 4.   Market analysis 7  4.1.Market structure 4.2.Consumption   4.3.Production   4.4.Key players 5.   Trade 5.1. Exports 5.2. Imports   5.3. Balance of trade 9 6.   SWOT analysis 11 7.   Outlook 12 8.   Recommendations 13 9.   Conclusion 13  Appendix References    Sectoral survey: Pharmaceutical Industry    3 1- Introduction Producing medicine is a strategic industry due to its importance on the social level and significant role in  protecting the human health. Billions of dollars are annually invested in research and development around the world to support this industry aiming to increase human's ability to face different kinds of diseases which is obviously reflected in the rising life expectancy for people especially in industrial countries where medicine production is highly concentrated in those countries .This industry has started in Egypt with Tal'at Harb and the establishment of the first Egyptian pharmaceutical company in 1939 under the name of Misr Company for Pharmaceuticals believing in the strategic importance of a strong national  pharmaceutical industry. It has undergone many changes along the history witnessing a wide variation in the key players controlling the market, attracting many investments to that growing field that forms about 30% of the pharmaceuticals supply in the MENA market, according to the American Chamber of Commerce in Egypt. So, this paper is spotting the main features of the pharmaceutical sector including demand, supply, patterns of trade and regulatory framework that organizes the sector. The paper also tackles strengths of the sector and particularly after liberalizing the industry, introducing an efficient registration system for new medicines and other factors that have collectively helped to make a leap in the  performance of this sector. However, it also mentions pessimistic views consider some threats endangering that sector like the new pricing system the Ministry of Health wants to adopt and the TRIPS agreement that may negatively affect the pharmaceutical industry in Egypt.    Sectoral survey: Pharmaceutical Industry    4 2- Definition The pharmaceutical industry develops, produces and markets drugs licensed for use as medication. There are different categories of medicine like: * OTC pharmaceuticals and prescription drugs  Over The Counter (OTC) pharmaceuticals can be taken with no need to a prescription in contrast to  prescription drugs. * Patented and generic medicine Patented medicine is the srcinal one that is firstly produced and generic medicine is the copy of the srcinal medicine. Patents form the major percentage of the value of drug demand. On the other hand, generic medicine represented 60.2% of the value of the pharmaceutical sector in 2008.   * Biologics & biosimilars Biological medicines are produced using biological processes and biosimilar medicines are copies of srcinal biological medicines. 3- Regulatory framework 3/1) Regulatory body The Egyptian Drug Authority (EDA), follows the Ministry of Health, is the regulatory body responsible for overseeing the pharmaceutical sector. Moreover, there are three sub-organizations follows EDA:   * The Central Administration of Pharmaceutical Affairs (CAPA) that is responsible for administrative regulations. * National Organization for Drug Control & Research (NODCAR) to supervise drugs. * National Organization for Research & Control of Biologics (NORCB) to control biologics meeting the WHO requirements and international standards.
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