CHAPTER 15
Regulatory Requirements in Pharmaceutical Industry
15.1 OVERVIEW OF REGULATORY REQUIREMENTS IN THE PHARMACEUTICAL INDUSTRY
The pharmaceutical industry is one of the most regulated among its peers. The evolution of pharmaceutical regulations is linked to the development of science and economic progress. Perhaps, that is why developed countries have a more evolved and complex regulatory system.
There are hundreds of regulations related to pharmaceuticals all over world. Almost every country has got their own regulations, in addition to global agencies like World Health Organization (WHO), have developed their own guidelines which may be followed in some countries, mostly developing ones who do not have their own. Also, for export of ...
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