The formalization of the Biologics Control Act in 1902 due to the diphtheria epidemic and Upton Sinclair’s The Jungle, which was released in 1906, led to many countries taking regulatory affairs for the pharmaceutical industry seriously. As of today, most developed countries have set regulatory bodies that govern the practices employed by companies operating in the pharmaceutical space.
Title 21 of the Code of Federal Regulations has a mention of regulatory affairs pharmacy and its related clauses.
The first initiatives towards regulating pharmaceutical science and its related applications in the European Union started in the 1980s. After some work, the European Union formalized the New Approach Directives. They first applied the New Approach Directives to medical devices, and this was the first important healthcare regulation in centuries.
The New Approach Directives adopted by the European Union seems to be an intensive healthcare regulation model, which has also been used as an international template in the Global Harmonization Task Force, a voluntary group of representatives from leading healthcare regulation bodies like the FDA from the United States of America.
Regulatory-affairs pharmacy is thus an emerging science, which is yet to be applied to all realms of healthcare and pharmaceutical sciences. For now, its application to medical devices helps surgical devices’ manufacturers to follow the best practices and ensure that top quality devices are available for choice. This standard has made it possible for the use of sterilized needles for use in injections, a significant step in ensuring quality healthcare treatment is provided.
Experts agree that there is a lot of research left that needs to be done in this domain. The application to all aspects of medicine notwithstanding, regulatory-affairs pharmacy is indeed an emerging field of pharmacy that works to regulate activities in the domain of pharmaceutical sciences. Bodies like the Regulatory Affairs Professionals Society (RAPS), The Organization for Professionals in Regulatory Affairs (TOPRA), and others work towards the same goal.
http://en.wikipedia.org/wiki/Regulatory_Affairs