All medicines must be approved by regulatory bodies in the countries where they are to be put on the market. In Europe, this approval is called “marketing authorisation” (MA). To obtain MA, pharmaceutical companies (along with other developers of medicines such as academic institutions, or individual researchers) must submit a comprehensive marketing authorisation application (MAA) and undergo a rigorous multi-step evaluation. For this paper, the word “company or companies” will be used to cover all “medicine developers” and this term also includes individuals and institutions. In Europe, the EMA issues recommendations to the European Commission regarding the potential grant of a MA, who then makes a legally binding decision. To secure these benefits, the company must request what is called “New Active Substance” or NAS designation or status, as part of its marketing authorisation application. NAS designation requires that the medicine meets certain criteria and if adopted, it prevents other parties from bringing a generic version of it to market for 10 years. Although the NAS status is a regulatory concept with defined criteria, demonstrating that an active substance has not been previously authorised in Europe often requires significant support from the Intellectual Property Department, as this is where most research on the product and its novelty has already been conducted for patentability purposes. Further, the criteria for granting NAS status have recently been made more stringent by the EMA. Obtaining market exclusivity for a product can help predict a company's value and growth thus it is important for companies to obtain this NAS status for their products. In this article we explore how different information resources and strategies were used by our company in two case examples to help verify NAS status in Europe. These case studies are based on a presentation given at the CEPIUG conference in 2023 and are not intended to be an in-depth guide.
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