Test data protection

Data test protection is constituted by information resulting from tests conducted with a novel molecule, which have determined the efficacy and safety of it.

Decision 486 of the Andean Community provides the ability to protect this information in terms of exclusivity. It also allows each country member the choice of whether or not to include these periods of exclusivity in their territory.

Also, Legislative Decree No. 1072 provides for the protection of data tests in the registration process of a new chemical entity (NCE) for a period less than the validity period of a health registration, that is, less than five years, counted from the date it was granted the registration in Peru or from the first commercial approval worldwide, for the case where the registration is based on such an approval.

During the aforementioned period, the registrant shall enjoy the right to exclude any person from the use of test data or other undisclosed information submitted for the approval of the health registration. The same rule also states that a NCE is a biologically active fraction responsible for the physiological or pharmacological action of an active ingredient, which at the time of application for licensing has not been included in medical records previously granted in the country.

Similarly, the decree states what cases will not be considered to be NCEs: