Counterfeiting and piracy are one of the biggest issues of the global economy in the last two decades, facing all industrial sectors, including pharmaceutical industry. Counterfeiting of medicines is a growing phenomenon affecting all type of medicines including both innovative and generic and represents a serious public health problem and a problem of the trade competition as an intellectual property right infringement. In order to combat this problem, anti-counterfeit regulatory activities are undertaken on a global level through establishment of legislation, strengthening the regulatory activities, development of mechanisms for effective collaboration between the stakeholders on national and international level and communication for raising public awareness regarding the risk of using counterfeited medicines. The role of the pharmaceutical manufacturers, wholesalers and retailers in the fight against counterfeited medicines is essential for securing the supply chain and providing quality, safety and efficacy of the medicines that reach the patients from one side and for protecting their
brands and their profit from the other side.
The Regulatory Affairs as a field in the pharmaceutical industry has a lot of potential for individual professional growth. Formerly viewed as a clerical profession, growing requirements from competent authorities for a more regulated pharmaceutical industry resulted in growing interest and demand for regulatory proffessionals. The pharmacists working in a modern regulatory department unit are today viewed as key figures in obtaining the company’s goals and objectives. Their expertise can undoubtedly contribute to improving the strategy for the eventual market launch of a pharmaceutical product and provide for a better overall process in developing new products as well as maintaining ones that are already registered.
In this essay we delve inside the image surrounding this department, and try to bring forward what is actually behind it. We then look inside the organizational structure and everyday activities of a regulatory department, and offer our thoughts into making the processes in that department more efficient consulting the latest insights from leading experts on this subject.
Ultimately, we try to include the application of technological advancements into the picture and what their contribution would mean for managing information and thus an efficient way of functioning in such departments.
Keywords: Regulatory Affairs, technology, information, organization, efficient
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