Approved at the Council of Ministers meeting held on Wednesday and announced today in a statement, two decrees establish a new regulatory framework for clinical research on devices and performance studies of medical devices.
“The new regime aims to ensure the robustness and reliability of the data produced, as well as the protection of the safety of people participating in clinical investigations and studies, in line with the objectives defined at the European Union level,” the executive stated.
Another legislative proposal was also approved to simplify and expedite the authorization procedures for clinical trials of medicines, introducing the possibility for participants to continue treatment with the drug in question after the trials.
The Government also approved a Decree-Law that redefines the model and criteria for approving the shifts of permanent service schedules for community pharmacies.
“This change aligns with the commitment to a network of proximity care, based on the direct and coordinated involvement of all public, private, and social institutions operating locally,” the statement added.
