Biosimilars and Pharma Innovations

Regulatory Affairs and Intellectual Property Rights

Regulatory Affairs contributes essentially to the overall success of drug development, both at early pre-marketing stages and at all times post-marketing. The pharmaceutical industry deals with an increasing number of interesting drug candidates, all of which necessitate the involvement of the quality assurance in regulatory affairs department.  The importance of intellectual property law is well established at all levels-statutory, administrative and judicial. It lays down minimum standards for protection and enforcement in member countries which are required to promote effective and adequate protection of intellectual property rights with a view to reducing distortions and impediments to international trade. The Agreement provides norms and standards in respect of following areas of intellectual properties are Patents, Trademarks, copyrights, Geographical indications, Industrial designs.