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Argentina: ANMAT Issues New Regulations on Bioequivalence

Thursday, August 03, 2017: The Argentina’s National Administration of Drugs, Food & Medical Technology (ANMAT) has issued new regulations on bioequivalence, establishing new deadlines for the presentation of studies and detailing which active ingredients require it.

Specifically, on 3 August 2017 Resolution 9222 was issued, establishing a deadline of 120 days to file in vivo protocol equivalence studies, as well as a deadline of 6 months for the filing of final results (counted from the in vivo studies date of approval).

If 2 or more equivalence studies need to be done, a work schedule must be presented (with a maximum duration of 2 years for the entire procedure).

Additionally, on 28 July 2017 Resolution 8870 was issued, establishing 13 active ingredients that will not require bioequivalence.

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