This book compares national and centralised procedure practices and key performance metrics, including current approval times, review practices and pharmacovigilance standards, in the seven Gulf States. Opportunities for an improved regulatory system are identified, which, if fully implemented, could have a significant impact on patients’ access to new medicines. The Persian Gulf represents the next growth market for the global biopharmaceutical industry but to date there has been limited information about the regulatory review processes employed in these countries. A thorough examination of the strategies currently being implemented by the Gulf States is considered critical to the future regulatory environment in this region. Pharmaceutical Regulatory Environment: Challenges & Opportunities in the Gulf Region is a must read for those interested in pharmaceutical regulation in the Gulf region.

Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.

Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.

Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.

Learn how international governments have committed themselves to improving access to quality health care! International Drug Regulatory Mechanisms explores the environment, organization, structure, functioning, and finance of health systems and pharmaceutical markets in 19 countries. Local experts describe each country’s experiences with and lessons learned from the regulation of pharmaceutical products. This book will help government officials, pharmacy educators, and pharmaceutical industry leaders from around the globe identify and develop successful methods for controlling pharmaceutical drug prices and utilization. In International Drug Regulatory Mechanisms, you will learn about the health care system of each country and each government’s measures to control drug costs. This text shows you what government interventions are feasible as well as effective, and the impact of these measures on consumers, government agencies, and the pharmaceutical companies and distributors. Drug policies, reimbursement concepts, and health insurance companies are all examined to give you a better working knowledge of the methodology and guidelines involving drug control in nations such as: Iceland Canada Israel Malaysia Argentina Taiwan Mexico Italy International Drug Regulatory Mechanisms is an extensive text that shows how pharmaceuticals are regulated throughout the world. This book examines how—despite similar goals—price controls, utilization controls, record keeping, and quality requirements differ greatly between countries. Using numerous graphs, tables, and figures, this one-of-a-kind resouce provides you with new insight into which strategies are superior and how to implement these strategies in your own country.

Managing international regulatory affairs is amongst the most critical aspects of developing and marketing pharmaceutical product(s) for the global life sciences industry. Any mistake, no matter how minor, can delay product(s) approvals, manufacturing, launches, or cause widespread public relations disasters. The real challenges are the inability to meet stringent regulatory, clinical and safety requirements of national authorities. Failure rates are very high in drug(s) discovery and development. The cost of failure gets added to the cost of successful medicinal product(s), which get to the market. Therefore, an update with changing regulatory requirements is essential for successful marketing of pharmaceuticals in multi-markets. The research problem in hand is to study 'Impact of Regulatory Environment on Pharmaceutical Marketing'; leading to why marketing activities in a pharmaceutical are different than other industries. The detailed study of Impact of Regulatory Environment on Pharmaceutical Industry included in this book.