Regulatory issues for export and import of pharmaceuticals and biologicla products in India, Brazil, Switzerland

Abstract

This article mainly focuses on the drug import and export from India, Brazil, Switzerland. Now a day’s foreign pharmaceutical companies have a better legal foundation for releasing new drugs. The medical regulatory system has become more complicated, and new drugs can take a year or more to be approved for marketing. Ever-changing laws and regulations are driving demand for regulatory affairs professionals to provide the current needs of industries for the global competition and who can help pharmaceutical companies to effectively bring their medical products to the countries. In today’s competitive scenario, the reduction of the time taken to launch the product is imperative and hence vital for company’s success. Biological products produced by biotechnological methods from living organisms are a diverse category derived. With the advent of new biotechnology techniques, the development of biological products has become safer and more consistent. A regulatory framework controls the manufacture, development, and use of biologics in clinical practice. Regulations are sets of standards and norms that manufacturers must follow to ensure maximum public protection from the developed products. Biological product regulation involves the overall management system to secure high levels of safety and quality of biological products.