The Federal Commission for the Protection against Sanitary Risks (Cofepris) reported in its latest Fortnightly Report on the expansion of therapeutic authorization of 102 health supplies, covering categories of drugs, medical devices and clinical trials.
Through the Sanitary Licensing Commission (CAS), Cofepris has carried out a detailed review and opinion on these forces, guaranteeing their safety, quality and effectiveness, the basic requirements for obtaining a sanitary registry and ensuring access to certain therapeutic options.
In this report corresponding to the first half of May, 11 new drugs were approved, including tremelimumab, a biotechnological agent used in the treatment of lung cancer, anaplastic lymphoma and hepatocellular carcinoma. Also, Cofepris has approved betamethasone/calcipotriol, a pharmaceutical product for the treatment of plaque psoriasis.
In addition, they granted registration to 83 new medical devices, of which 21 were intended for medical treatment. These devices include ankle fixation implant systems and decellularized allografts, as well as soft tissue needle biopsy.
44 There were also thoughts on the diagnosis of various diseases such as cancer, diabetes, pneumonia, enteritis, cholera, chikungunya, herpes, celiac disease and heart failure, among others. Additionally, they tested 18 medical instruments, such as infusion pumps, surgical instruments and surgical microscopes.
There are eight new green studies on clinical trials. Among them, a phase I trial of an antibody used in the treatment of cancer stands out, as well as a phase II trial to evaluate the effectiveness and safety of the treatment for chronic obstructive pulmonary disease (COPD).
Strict regulation by the health authority in relation to drugs, medical discoveries and clinical trials, together with transparency in disclosing information, guarantees access to safe, effective and quality healthcare.