Argentina Revises Drug and Vaccine Approval Policies
Argentina plans to review fast-track authorizations for costly drugs and mandate placebo groups in vaccine trials. The health ministry emphasizes patient safety and evidence-backed innovation, aiming to ensure public trust and system sustainability.
In a significant policy shift, Argentina's government announced plans to review fast-track authorizations for high-cost drugs. These changes will focus particularly on medications for children and rare diseases. The revised policy aims to strengthen evidence foundations, enhancing patient safety and ensuring the sustainability of the healthcare system.
The Ministry of Health stated that while innovation is crucial, it should not lead to rushed decisions without solid evidence. The government intends to initiate technical discussions on the approval criteria for these drugs, prioritizing patient safety above all.
Additionally, the government mandates that vaccine trials include a placebo control group, setting it as a minimum scientific standard. This move is aimed at improving scientific rigor and boosting public confidence in the nation's healthcare system.
(With inputs from agencies.)
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