Argentina to Shorten the Clinical Trials Approval Timelines

On April 26th, The Ministry of Health in Argentina (ANMAT) has issued a new regulation that shortens the timelines for the approval of clinical trials from 160 business days to 70 days (60 days for review and 10 days for administrative paperwork). If ANMAT does not process the cases within that period, the approval would be automatic.

The new regulation comes after Argentina's president, Mauricio Macri, addressed the regulatory bodies to change the approval times during a meeting with the members of the national government in Casa Rosada, when he launched a state modernization plan.

According to President Mauricio Macri, ANMAT takes almost a semester to approve clinical studies. Argentina is expecting to double the trials running in the country in the next 24 months. In an effort to make Argentina a more agile state, the president urged the agency to shorten these deadlines to 70 days.

In addition, since many of these studies require temporary importation of equipment and drugs, customs also pledged to simplify their process and work alongside ANMAT.

The full resolution (ANMAT No. 6677/10) in Spanish can be accessed here:

http://www.anmat.gov.ar/boletin_anmat/BO/Disposicion_4008-2017.pdf