Admission conditions for the results of Bioequivalence studies conducted abroad

Under Disposition No. 2434/2013, it was established that: "holders of medicinal specialty laboratories containing APIs, for which this National Administration requires the performance of Bioequivalence studies, who request approval of results of studies conducted abroad, must comply with the requirements detailed in Annex I of this Disposition…", which sets out the guidelines for accepting the results of bioequivalence studies conducted abroad.

ANMAT informs professionals and companies that, in the current context and in view of the needs identified during the time this regulation has been in force, this National Administration has decided to conduct a full evaluation of the results submitted under the terms of Disposition 2434/13, in conjunction with Disposition 5640/22, in the following cases:

• When the requesting laboratory cannot reliably demonstrate, with the relevant documentation, that the API of the medicinal specialty to be registered in the country has been declared bioequivalent, compared to the reference pharmaceutical product, by decision of the health authority with jurisdiction over medicines in the country of origin; and/or
• When the formula, pharmaceutical form, route of administration, concentration, or place of manufacture of the corresponding products do not match; and/or
• When the health authority in question does not have regulatory legislation that converges with national legislation on the matter.

For this purpose, the applicant must submit, through the Remote Procedures (TAD) platform, the following documents translated into Spanish by a certified translator: summary or synopsis of the study's clinical protocol; statistical data from the study required by ANMAT Disposition No. 5040/06, demonstrating that the test product is bioequivalent to the reference pharmaceutical product; the reference product used in the study, which must be the same as that adopted by this National Administration, except for its place of manufacture; approval, where applicable, of the biowaiver of the different concentrations of the test product; and, if changes have occurred, the declaration of post-registration changes to the test product.

This regulation will take effect as of January 29, 2025.