2023-06-21 18:19:20
149 new health supplies were approved: 25 medicines, 116 medical devices and eight clinical trials Biotechnological drug for acute lymphoid leukemia stands out
Mexico City, June 21, 2023.- The Federal Commission for the Protection once morest Sanitary Risks (Cofepris) announces that, according to the most recent Fortnightly report on therapeutic expansion149 health supplies were authorized in the categories of medicines, medical devices and clinical trials.
In the report corresponding to the first half of June, the authorization of 25 drugs is reported, including efavirenz/lamivudine/tenofovir disoproxil fumarate, a new molecule for the treatment of HIV, and L-asparaginase, a biotechnological agent for acute lymphoid leukemia. .
Likewise, 116 new medical devices obtained a health registration, of which 21 are for medical care; among them are: hearing aids; a closed wound drainage system; a system of osteosynthesis plates and screws and total knee and shoulder prosthesis. Likewise, 35 are medical equipment, among which a subdural anesthesia kit stands out; blood glucose meters; a flexible videolaryngoscope and instruments for hip prosthesis. Finally, 60 are for measurement of glycolized hemoglobin, liver function, hormones, copper, zinc, p24 antigen for HIV detection, tetanus toxin, trypanosoma cruzi and rheumatoid actor, among others.
Eight new clinical trials were also authorized: three for drugs for the treatment of cancer, one for children over 12 years of age and adults with severe hemophilia A or B, and a protocol to determine the effects of HIV treatment in people with obesity.
Through the work of the Sanitary Authorization Commission (CAS), Cofepris fully complies with guaranteeing access to health supplies, subject to strict review and opinion that verifies their safety, quality and efficacy, necessary to obtain the sanitary registry. .
The generation and publication of Fortnightly report on therapeutic expansion it is a full exercise of transparency of this authority towards the regulated industries and patients, the central objective of an agile, fair and transparent health regulation.
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