The Ministry of Public Health and Social Assistance through Ministerial Agreement 299-2019 approves the new Regulations for Clinical Trials in Humans, which are effective from December 31, 2019.
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 have incorporated the changes that have been made to the World Medical Association Declaration of Helsinki (2013); Royal Decree of the Spanish Medicines Agency (2015); the International Conference on Harmonization (ICH) (2016): and the International Ethical Guidelines for Health-related Research Involving Humans CIOMS/WHO (2017).
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.