Regulatory affairs (RA), also called government affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, biologics and functional foods).
Regulatory affairs professionals (aka regulatory professionals) usually have responsibility for the following general areas:
Ensuring that their companies comply with all of the regulations and laws pertaining to their business. Working with federal, state, and local regulatory agencies and personnel on specific issues affecting their business, i.e., working with such agencies as the Food and Drug Administration or European Medicines Agency (pharmaceuticals and medical devices); The Department of Energy; or the Securities and Exchange Commission (banking). Advising their companies on the regulatory aspects and climate that would affect proposed activities. i.e. describing the "regulatory climate" around issues such as the promotion of prescription drugs and Sarbanes-Oxley compliance.
Regulatory Affairs independently and as a profession have important positions to play in positively impacting medication policy, medication use and results as well as other aspects of medical proper care. In many instances this will be through cooperation with other wellness care professionals at a community stage. The following are the various actions that comprise the application of drug proper want to individuals. If performed, in whole or in part, they will result in added value to medication treatment by making a beneficial participation to the safe and affordable use of drugs, leading to beneficial results and improved medical proper care. Obtain and maintain medication records and relevant wellness details, if they do not already exist. This detail is essential to evaluate personalized medication treatment. Identify, evaluate and assess: Medication related problems, Symptoms described by patients, self-diagnosed conditions. The elements of drug proper take proper individual sufferers, taken together, explain comprehensive drug proper care, the delivery of which requires an ongoing, covenantal relationship between the pharmacologist and the affected person.