The art of writing is the art of discovering what you believe.
Gustave Flaubert

Tuesday 12 July 2011

Regulatory Data Protection

A form of data exclusivity, protecting the data generated by the pharmaceutical and agro-chemical industries and submitted to the relevant authorities when applying for market authorisation. TRIPs requires that such data be protected: it does not specify a period, but 5 to 10 years from approval of new chemical entities (NCEs) is common. RDP keeps the information submitted to regulators confidential, and prevents others being able to rely on the originator's data in connection with approvals for generic alternatives. RDP therefore provides protection for the financial investment involved in discovering and developing these products, not entirely unlike what patents do. RDP is even sometimes referred to as a form of intellectual property.
Not to be confused with data protection, which is generally used to refer to the protection of personal data against invasions of privacy. For more information, see

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