The term ‘Data exclusivity’ sometimes mentioned in the refers toa)The...
Option (a) is the correct answer.
Option a is correct. Data exclusivity is protection of clinical trial data which is submitted to the regulatory authorities to prove safety, quality and efficacy of a new drug, and preventing the generic drug manufacturers from relying on this data in their own applications.
Option b is incorrect. Patents are an important form of intellectual property, but are not themselves necessarily sufficient to create the favorable environment needed to support the development of medical advances. Data exclusivity is not an extension of patent rights, and it does not prevent the introduction of generic versions of the innovative drug during the data exclusivity period, as long as the marketing approval of the generic version does not use or rely upon the innovator’s test data. Patents and data exclusivity are different concepts, protect different subject matter, arise from different efforts, and have different legal effects over different time periods.
Option c is incorrect. The critical data which is not meant to share with foreign countries without the consent of citizens is Data Protection through data localisation.
Option d is incorrect. The data of intellectual property can be shared for generic medicine development without the consent of patent owners after a certain period of time is called compulsory licensing.
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The term ‘Data exclusivity’ sometimes mentioned in the refers toa)The...
Data exclusivity is a term often mentioned in the context of regulatory approval of pharmaceuticals and refers to:
Protection of Clinical Trial Data
- Data exclusivity refers to the protection of the clinical trial data that pharmaceutical companies submit to regulatory authorities for the approval of new drugs.
- This protection ensures that the data submitted by the companies is not used by competitors to gain approval for generic versions of the same drug for a certain period of time.
- It allows the original pharmaceutical company to have exclusive rights to the data for a specified period, usually ranging from 5 to 10 years, depending on the jurisdiction.
In conclusion, data exclusivity is a crucial aspect of the regulatory framework for pharmaceuticals, ensuring that companies are incentivized to invest in research and development by providing them with a period of exclusivity to market their products based on the data they have generated through clinical trials.