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Top1. Introduction
In the Middle East, pharmaceutical companies are facing a heavy pressure from the regulatory authorities that are concerned with monitoring the medicines markets, by applying very tough regulations and standards to ensure the products quality. These regulations can be applied and mapped through implementing robust information systems (ISs). The advances in science caused major leaps forward to modern medicine from the nineteenth century onwards, and the evolution of scientific knowledge has pushed forward the growth of the modern pharmaceutical industries (Gribben, 2004). According to Abdulzaher (2013) “The Gulf countries are expected to invest USD 12 billion in the pharmaceutical industry by 2020 and Saudi has the largest market for medication in the region with USD 5.1 billion in 2012”. Alpen Capital’s 2014 report (Alpen Capital, 2014) estimated that the size of the Gulf Cooperation Council (GCC) healthcare market would become US$ 69.4 billion by 2018 from US$ 39.4 billion in 2013 with the 12% annual growth. Pharmaceutical companies are driven by many of the rigorous regulations and standards that are controlling and monitoring the drug development and production life-cycle. As shown in Figure 1 (Laínez et al., 2012), the finished product of the drug production starts from product development processes (which can take years until reaching the final formula), stability studies (which take 2-3 years in incubators in different temperature and humidity atmosphere), product registration (which will take also almost one year of the file submission), and then will start the manufacturing processes starting with material requirement planning, production and capacity planning, right down to delivering the finished product to the end user in the market (Laínez et al., 2012).
Figure 1. Product life cycle (Laínez et al., 2012)
All of the above aspects raise the need of having the right tools that ensures compliance with regulations. The information system (IS) is perfect in serving this purpose as it has the ability for managing the huge data records, and make it accessible, and easily analyzed. Therefore the advantages it offers include; (i) Comprehensive enhancement of the organization business processes, (ii) adaptation of all the desired standards and best practices to the environment and (iii) such an integrated and compliant IS would positively support strategic decision making.
The scope of this research work includes (i) identifying the standards and regulations that regulate and control the pharmaceutical industry in the Middle East, (ii) identifying the risks and problems that pharmaceutical companies are facing due to the lack of information, (iii) identifying the main factors of IS implementation success in the pharmaceutical industry, and (iv) addressing the impact of ISs on improving the management decisions. This research focuses on the pharmaceutical industry business in the Middle East due to the fast growth in this area of the world in healthcare sector, and the huge investment in this industry in the region. Although this paper is in favor of the extensive and positive effect of implementing ISs in such a highly regulated business environment, and in the same time will answer all the concerns that impose the other opinions that using ISs will make their tasks harder, and will make the business processes more complicated.