PRINCIPLES AND GUIDELINES FOR REGULATORY AFFAIRS OF PHARMACEUTICAL PRODUCTS

Abstract

The regulation of medical products has been expanding since early 20th century. Regulatory agencies are being established in an ever increasing number of countries across the globe. Those that have established are reorganizing their systems and attempting to harmonize with organizations of other countries . The pharmaceutical, biotechnology and medical devices are among the most highly regulated industries in the world. Regulatory affairs (RA) professionals are employed in pharmaceutical industry, government, academic research and clinical institutions. The Indian Pharmaceutical industry is one of the fastest growing industries in India, with a compounded annual growth rate (CAGR) of over 13 % in last 5 years and it is expected to grow at a higher rate in coming 10 years. It is valued at $ 8.0 billion approximately and ranks 4th in terms of volume and 13th in terms of value globally2 . All companies engaged in R&D worth its salt has an individual RA department to aid them in new product development. The clinical research industry, which provides opportunities for RA professionals, is also growing at an unparalleled rate. It has opened up new vistas of employment for a large number of trained professionals. The clinical trials market worldwide is worth over USD 52 billion. A study by Ernst and Young indicates that the total market value of Clinical Research activities performed in India is expected to grow to around USD 1.5-2 billion. There is expected to be a huge demand for qualified RA personnel in clinical research.