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Data Exclusivity

Before a drug is placed on the market, it must receive approval, in other words, it must be registered. In order to be registered, the effectiveness and safety of the drug must be proven with research data. Data exclusivity encompasses the protection of all research data that the research-based pharmaceutical company provides to the Ministry of Health throughout the registration process. Today, in developed countries, data that are provided to authorized official entities are placed under protection for a certain period of time in order to prevent other companies from referencing and disclosing them, thereby preventing unfair competition. This implementation is referred to as "data exclusivity" in international law.

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© Association of Research-Based Pharmaceutical Companies Last Update : 02.02.2012
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