New Regulation for Clinical Trials in Humans
The Ministry of Public Health and Social Assistance through Ministerial Agreement 206-2021 approves the new Regulations for Clinical Trials in Humans, which are effective from October 30, 2021. Ministerial Agreement 299-2019 of the Ministry of Public Health and Social Assistance, Regulations for the Regulation of Clinical Trials in Humans, is repealed.
This Regulation aims to unify the procedures that allow the promotion of policies aimed at health research and technological development of the country and thus comply with the provisions of Decree 90-97 “Health Code”.
It also modifies and nuances aspects that had already been included in previous Regulation and emphasizes respect for people, welfare and justice as ethical principles that should be applied when conducting clinical trials in humans and that these gather the main elements for an ideal progress in the country’s clinical studies.
It is important to mention that the new regulation has implemented clinical trials in public health emergency situations which is only applicable in cases of health emergency decreed by the Government of the Republic of Guatemala and will be effective only for the duration of such emergency. Establishing the applicable provisions and procedures. It is also important to note that the new regulation has implemented the Good Clinical Practices course which will aim to address special issues for the successful conduct of clinical trials.
Failure to comply with the new Regulation for Clinical Trials in Humans will give cause for the cancellation of the Trial in addition to the administrative, civil and criminal sanctions that would apply.