MODIFICATION OF THE REGULATION OF CLINICAL TRIALS.- By Supreme Decree No. 028-2023-SA, several articles were modified and incorporated into the Regulation of Clinical Trials, approved by Supreme Decree No. 021-2017-SA.
The most important modifications and incorporations are as follows: – It differentiates between minor change from substantial change to the protocol and/or consent format. The minor change requires the authorization of an Institutional Research Ethics Committee (CIEI). The second type of change, the substantial change, called an amendment, requires authorization from the INS Directorate of Research and Innovation. – New responsibilities are included for the sponsor to ensure that an IREC, registered and accredited by INS, approves all documents related to the clinical trial; and to ensure that minor changes in the protocol or consent form conform to clinical trial regulations.
DIGEMID
HIGH COST DRUGS AND BIOLOGICAL PRODUCTS.- Ministerial Resolution No. 1004-2023/MINSA established the threshold for high cost drugs and biological products at 6 UIT.
The term threshold refers to the economic amount that marks the point at which a drug or biological product is classified as high cost. This value is determined from the annual expenditure on drugs or biologicals used in the treatment of a patient.
This rule does not apply to oncological pharmaceuticals and pharmaceuticals for rare or orphan diseases, whose high cost thresholds are contemplated in Ministerial Resolution N° 964-2022/MINSA and Ministerial Resolution N° 109-2022/MINSA, respectively.
