Argentina tightens requirements for clinical trial applicants
This article was originally published in SRA
Executive Summary
Argentina’s National Medicines, Food and Medical Technology Administration, ANMAT, has strengthened its regulations on clinical trials in response to the increase in the number of clinical trial applications that are being submitted and as a follow-up to the implementation of other rules earlier in 20081,2. The rules mainly deal with the functions and activities of ethics committees and the rights, safety and integrity of triallists.