The Networking Issue Feature: Introduction
Balancing Global and Local Concerns in Manufacturing and the Supply Chain
The pharmaceutical industry is increasingly global in nature. Drug companies began outsourcing to contract research and manufacturing organizations to realize cost and efficiency gains. Many APIs found in generic and even branded small molecule drugs are now produced in China, India and other emerging markets, and biosimilars are increasingly produced across the world.
The continued growth of the industry and — particularly the rapid development and commercialization of antibodies and next-generation medicines, such as antibody–drug conjugates and cell and gene therapies — has led to an explosion in the number of clinical trials conducted. Finding patients for all of these trials is not possible in the developed world alone. Trials for orphan drugs — an increasing fraction of the pipeline — present even greater recruitment challenges.
Improved economies and an expanding middle class with greater buying power is driving growth in demand for state-of-the-art medicines in emerging markets, leading governments to require local pharmaceutical production and the inclusion of members of their populations in clinical trials.
The consequences of this globalization are extensive. Drug manufacturers must often conduct multiple clinical studies to satisfy varying requirements of different national regulatory agencies, leading to higher costs and longer approval times. However, many emerging economies lack the requisite infrastructure, skilled labor/expertise and established regulatory frameworks.
Pressure has increased to align pharmaceutical regulations on a global basis. Regulatory harmonization on standards, methods and scientific principles is occurring on a global and regional basis.
The World Health Organization and the International Council on Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) have been instrumental in establishing standards and guidelines for the global pharmaceutical industry.
Membership in ICH continues to expand, and global regulatory authorities have recently formed organizations to tackle the challenges of harmonization. The United States and the European Union are implementing a formal mutual recognition agreement, while regional efforts have been initiated in Africa, Latin and South America, Asia-Pacific and the Middle East.
Further globalization — and glocalization — of the pharmaceutical industry is expected. All members of the pharmaceutical value chain must be prepared to collaborate and cooperate on true global regulatory harmonization to lower drug costs, reduce time to market, expand access and, most importantly, ensure the development and manufacture of safe and effective medicines.
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