Regulatory and Legal Aspects of the Drug Lifecycle

The process to discover, develop, obtain, and maintain regulatory approval is highly controlled, and the pharmaceutical industry is considered to be one of the most highly regulated industries in the world with strict restrictions on patenting, testing, marketing and safety of the products supplied. Prior to obtaining approval to be placed on the market, numerous investigations are conducted both in the preclinical and clinical setting, all of which are regulated by various laws, regulations and guidance documents. Once all of the steps in drug development are accomplished and all information and results from preclinical and clinical studies are available, approval to place a new drug may be obtained. However, once obtained, the marketing authorization holder is obliged, according to applicable laws and regulations, to report to regulatory authorities all variations/post-approval changes to the previously authorized documentation throughout the drug’s life cycle. All of this is performed in order to maintain the safety of patients who are treated with these products.