Pharma and Drug Safety

Regulatory Affairs and Intellectual Property Rights

Intellectual property (IP)  is a category of property that includes intangible creations of the human intellect.Intellectual property encompasses two types of rights: industrial property rights (trademarks, patents, designations of origin, industrial designs and models) and copyright.It was not until the 19th century that the term "intellectual property" began to be used, and not until the late 20th century that it became commonplace in the majority of the world

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 (medical affairs) professionals (aka regulatory professionals) usually have responsibility for the following general areas;

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.

The Agreement provides norms and standards in respect of following areas of intellectual properties are Patents, Trademarks, copyrights, Geographical indications, Industrial designs.