REGULATORY CHALLENGES IN GLOBAL PHARMACEUTICAL MARKETAbstract
The global pharmaceutical industry “looks like the epitome of a modern, mature industry that has found a comfortable way to make profits by the billion: it’s global, hi-tech, and has the ultimate customer, the health care budget of the world’s richest countries. A number of factors contributed to the globalization of the pharmaceutical industry. Chief among these are the convergence of medical science and practice under the influence of modern communication technology and increased and information exchange. The global success of the Swiss pharmaceutical industry is only due to the high level of investment in research and development and the other fact is the favorable regulatory frame work. For the development of a new drug and generics pharmaceutical company have to face number of regulatory challenges such as bioequivalence, patent expiry, newer antibiotics ,and the complexity involved in the regulated market etc. Regulatory processes are also undergoing international harmonization. As international market becomes more important, pharmaceutical companies will require greater corporation among national regulators to get life saving products which will help them to market faster and reduce regulatory compliance.
Vibhu Yadav* and Deepak Kaushik
M. Pharmacy (Drug Regulatory Affairs), Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak, Haryana, India
07 October, 2011
04 November, 2011
29 January, 2012