Data Exclusivity: The Implications for India  By Alfred Adebare, Of Counsel, LexCounsel, Law Offices E-mail: aadebare@lexcounsel-india.com  What is Data Exclusivity:  Data exclusivity refers to a practice whereby, for a fixed period of time, test and other data provided to the drug regulatory authority ("DRA") of a country (to demonstrate the efficacy and safety of a medicinal product [1]) in order to obtain an authorization to place the product on the market in that country, are not allowed to be used to register a therapeutically equivalent generic version of that product. Oftentimes, this data arises out of many years of research and clinical trials and is very expensive for the originator of the drug to produce.  If you want to know more, take a look at  act practice test.  he framework for pharmaceutical regulation and authorization attempts to protect the investment of companies in their innovations by providing periods of so-called data exclusivity.  For example, in order for a generic drug[2] to be approved in the European Union ("EU"), it goes through what is called an abridged product license registration process. Generics companies have to prove bioequivalence to the original innovator's reference product, but do not have to conduct clinical trials that proved the efficacy and safety of the medicinal product. They are allowed to use the test and other data presented by the originator to gain the product license in a country. However, the generics companies are not allowed access to this data until the product has been approved in the EU for 6 or 10 years, depending upon the type of marketing authorization (centralized or otherwise), or the country of sale.  In essence, data exclusivity refers to a period during which no third party applicant can rely on data filed by the original applicant for a marketing authorization. Accordingly, during this exclusivity period any subsequent applicant would need to have generated its own data to support the safety and efficacy of the product. It has, therefore, been argued, that data exclusivity is a misleading term; a more appropriate term would be market exclusivity.  During the data exclusivity period, the so-called abridged procedure for third parties obtaining a marketing authorization will not apply. After the data exclusivity period, the DRA is able to internally refer to the data of the originator company in order to assess the generic application for safety and efficacy and the abridged procedure permits an applicant for a marketing authorization to omit the pre-clinical and clinical test results normally necessary to support an application in circumstances where the equivalent data has already been filed by a third party in relation to a product that has already been authorized for sale in circumstances where:  the medicinal product is "essentially similar" to the product which is the subject of the earlier authorization; the earlier authorization was granted within the EU and has been in force for the exclusivity period; and at the time of the abridged application, the earlier approved product is being marketed in the member State where the abridged approval is being sought. Data exclusivity in the EU is regulated by Article 4 of Directive 65/65/EEC (as amended from time to time) of the EU and interpreted in accordance with several judgments of the European Court of Justice. In terms of the most recent Directive 2004/27/EC, the 6 or 10 years exclusivity and protection periods has now been harmonized. The new Directive provides for 10 years of data exclusivity for results of preclinical tests and clinical trials that must be submitted when applying for marketing authorization, irrespective of the authorization procedure used. Though a generic applicant can file for approval on the 8th anniversary of the innovative product's approval, the generic authorization must await the 10th anniversary.  For more info, visit this site



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