Navigating Kuwait’s Pharmaceutical and Life Sciences Regulatory Landscape: (Part I of II) In an era where regulatory certainty underpins public trust in healthcare systems, few institutions command the same global stature as the U.S. Food and Drug Administration (the FDA). Renowned for its rigorous pre-market evaluations and robust post-market surveillance,…
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New Era of Pharmaceutical Regulation in the UAE: Changes to Federal Law No. 38 of 2024 For quite a while now, the United Arab Emirates has led in health care and pharmaceutical innovations across the Middle East. The UAE government passed Federal Law No. 38 of 2024, which became effective…
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A New Landscape for Import, Distribution, and Manufacturing of Pharmaceutical Products in the UAE The United Arab Emirates (UAE) presents a dynamic and rapidly growing market for life sciences companies. This promising landscape is shaped by evolving opportunities and challenges in the import, distribution, and pricing of medical products, including…
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Economic and Fraud Provisions in the Middle East “There is one and only one social responsibility of business – to use its resources and engage in activities designed to increase its profits so long as it stays within the rules of the game, which is to say, engages in open…
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Pharma 2020 Bahrain 1. What are the main laws governing the manufacture and sale of pharmaceuticals in Bahrain? Bahrain Decree-Law No. 18/1997 with Respect to the Practice of Pharmacists and Pharmaceutical Centres (as amended by Bahrain Decree-Law No. 20/2015) (the Law). 2. Are there any significant differences in this area…
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A Guide to Medical Malpractice: A Medico-Legal Team Is Central to Your Case A patient goes to the doctor or hospital, trusting the ability of the healthcare professional in curing any ailment. Complete trust is placed upon the doctor's skills and knowledge, his specialty, and the various professional degrees suffixed…
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Detailed FAQ on the Distribution and Import of Pharmaceuticals in India Distribution of Pharmaceuticals in India The Indian pharmaceutical distribution system has a limited number of orbits – the pharmaceutical manufacturers; the clearing and forwarding agents (CFAs/ depots); stockists; wholesalers; and retailers. Clearing and Forwarding Agents What constitutes the role…
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A Guide to Laws on Medical Negligence in the Middle East Since the middle of the twentieth century, the medical profession has demonstrated an increase in the incidence and severity of medical liability lawsuits. Some are of the opinion that the rise in litigation is useful as learning from errors…
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Distribution of Pharmaceuticals, Medical Devices and Medicines: Kuwait Introduction The area of the Gulf Cooperation Council (GCC) is regarded as an "emerging market" for pharmaceutical exports and bilateral trade. Learning this region's regulatory requirements can be beneficial for pharmaceutical exports. The Gulf countries ' regulations promote the importation of quality generic…
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Regulation on Medicinal Products, Clinical Trials and Pharmaceutical Industry in the UK Imagine that you are an entrepreneur in the pharmaceutical industry having recently made a scientific breakthrough in a critical field. Your first instinct is to get this breakthrough certified and licensed, so it can be manufactured and sold…
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Liberating Farmers’ Rights While Ensuring Food Security: The International Seed Treaty Three intricately related concepts: climate change, biodiversity, and food security have become a central discussion amongst international political bodies over the last three decades. Analyzed from a unidimensional perspective in respect to Earth’s exponential population growth and carbon-emitting…
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Recent Development in Abu Dhabi Healthcare Sector “It is health that is real wealth”- Mahatma Gandhi Introduction Over the past decades, the UAE health sector has witnessed a dramatic change along with impressive growth. UAE has a federal government which oversees the entire country’s health sector. The government also finances…
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CRISPR Gene Editing Technology The Human Advancement Human often marvels at the things they create. From large structure to technologically mind-blowing machines, many impressive achievements warrant awe and amazement. A close look at these things will reveal their workings and both their strengths and their flaws. However, surrounded by all…
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Pharmaceutical Industry in the UAE 1. What are the primary laws and regulations governing pharmaceutical companies in the United Arab Emirates? The primary piece of legislation governing pharmaceutical companies in the United Arab Emirates is Federal Law Number 4 of 1983 concerning the Pharmaceutical Profession and Pharmaceutical Institutions (the Pharmaceutical…
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