- Among the new options there are 5 that are innovative and 15 generic.
- In addition, 10 clinical trials were authorized to evaluate new therapeutic alternatives for diseases such as hepatitis B, breast cancer, lupus nephritis, inflammatory bowel disease, and atopic dermatitis.
- Among the new drugs approved by Cofepris, encorafenib stands out, which is used for the treatment of colon cancer and advanced melanomas.
One of the responsibilities of the Federal Commission for Risk Protection Sanitarios (Cofepris) is to authorize the use of new medicines in Mexico. With this in mind, through a press conference, he released his second Fortnightly Report on Therapeutic Expansion. Among the main points, it indicates that during the In the last 15 days, 20 new drugs have been authorized, of which five are innovative and 15 are generic.
The technical work carried out by this federal commission makes it possible to guarantee the balance between innovative and generic medicines. Thus, the former represent new therapeutic alternatives in Mexico, while the latter expand therapeutic options, providing greater access at lower costs.
The owner of Cofepris, Alejandro Svarch Perezconfirmed that Mexico has an authority that provides reliable and effective protection against health risks, highlighting its operational technical and regulatory policy capacity.
Transparent information for the entire population
For his part, the interim representative of PAHO/WHO in Mexico, Juan Manuel Sotelo Figueiredohighlighted the exercise carried out by Cofepris to periodically publicize the drugs, medical devices and clinical trials approved by this health authority.
“People have the right to health and here we have been shown approved drugs, as well as clinical trials and medical devices. This will help people have more access to options and tools that will help them improve their health. This goes hand in hand with the fact of considering health as a human right”.
in the list of new drugs approved by Cofepris include encorafenib, which is used for the treatment of colon cancer and advanced melanomas, in conjunction with other therapies. It belongs to the group of kinase inhibitor drugs, which represent one of the greatest advances in the treatment of this type of tumor.
The new medicines authorized by Cofepris cover 11 different therapeutic groups
- Analgesics: paracetamol/tramadol; etoricoxib/tramadol.
- Anesthesiology: ropofol.
- Endocrinology: desmopressin; metformin/vidagliptin (2); teriparatide.
- Gastroenterology: esomeprazole.
- Hematology: tranexamic acid.
- Infectious disease: daptomycin.
- Neurology: carbidopa/levodopa; levetiracetam.
- Oncology: etoposide; encorafenib; vinblastine; tofacitinib.
- Psychiatry: amphebutamone; methylphenidate.
- Rheumatology: hydroxychloroquine.
- Emergencies: norepinephrine.
Registrations of new medical devices
In addition, Cofepris authorized 103 health registrations for medical devicesof which 70 percent is oriented to the diagnosis of diseases, 21 percent is for treatment, and nine percent corresponds to supplies for general medical care.
Among the approved products, a new alternative stands out for the detection of acute myocardial infarction, with greater opportunity than the usual options. It also allows the detection of highly specified proteins that occur in the early stages of this type of disease, as well as a device that helps manage complications caused by valve replacement surgeries.
Cofepris also authorized 10 clinical trials to evaluate new therapeutic alternatives for diseases such as hepatitis B, breast cancer, lupus nephritis, inflammatory bowel disease, and atopic dermatitis, among others.
As part of the strategy to be an agile regulatory agency, based on technical and scientific principles, the Health Authorization Commission (CAS) works with a large team of specialized reviewers who determine the authorization for the manufacture, marketing and use of medicines and devices. doctors who represent innovation in favor of the health of the population.
Cofepris issues sanitary records to those health supplies that verify compliance with standards through scientific and technical studies. In addition, the examiners of this authority periodically verify that the products that have already obtained registration maintain the quality and safety conditions.
This health authority reiterates its willingness to contribute with the best alternatives for the supply of effective and safe medicines, putting patients at the center of decision-making with the aim of protecting them and guaranteeing access to quality treatments. The biweekly reports can be consulted at this link.
Also read:
Cofepris authorizes 23 new medicines and 153 medical devices: This is the complete list
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List with the 83 new drugs approved by Cofepris during 2021