- With strict technical-scientific criteria, the record authorization is reached
of 176 inputs for health, exceeding more than 11 per day. - Agile regulation represents innovation in favor of the health of the population
- Among the new drugs recently approved by Cofepris, four oncologicals and a highly complex input such as the mechanical ventilator stand out.
The Federal Commission for the Protection against Sanitary Risks (Cofepris) announced during the press conference the First Fortnightly Report of Therapeutic Expansion, which in the last 15 days has evaluated more than 300 medicines and 450 medical devices, issuing health registration for 23 new medicines and 153 medical devices.
As part of the strategy to be an agile regulatory agency, based on technical-scientific principles, the Sanitary Authorization Commission (CAS) works with a large team of specialized reviewers. They are the ones that determine the authorization for the manufacture, commercialization and use of medicines and medical devices that represent innovation in favor of the health of the population.
The owner of Cofepris, Alejandro Svarch Perez, pointed out that this commission has a clear vision of access. The more efficient the health authority is, there will be a direct impact on more therapeutic alternatives for patients, whether it is a new innovative medicine that treats a disease for which we currently have no treatment or to reduce costs, giving more options for therapeutic offers in the market.
List of new drugs approved by Cofepris
Among the authorized medicines, during the month of March, which expand the therapeutic offer for the Mexican market, four oncological ones stand out: dexrazoxane, fluorouracil, methotrexate, and arsenic trioxide.
The distribution of therapeutic groups by medical specialty is integrated as follows:
- Analgesics and others: celecoxib; ketorolac/tramadol; paracetamol/amantadine/chlorpheniramine
- Anesthesiology: sugammadex
- Endocrinology: rosuvastatin
- Gastroenterology: mesalazine; omeprazole
- Gynecology: norestigmate/ethinyl estradiol
- Hematology: enoxaparin
- Infectious diseases: albendazole/quinfamide; oseltamivir
- Pulmonology: indacaterol/mometasone
- Neurology: natalizumab; pregabalin
- Oncological: dexrazoxane; fluorouracil; methotrexate; arsenic trioxide
- Psychiatry: desvenlafaxine; duloxetine; lemborexant
- Rheumatology: glucosamine/chondroitin; infliximab
Newly Approved Medical Devices
During the same period, it was also awarded health registration for 153 new medical devices. This expands the options for medical care in the country for the benefit of public health. Within the diversity of medical devices, a highly complex mechanical ventilator stands out. To know the complete list with all the names you can consult this link.
For its part, Cofepris recalled that it 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.
The protection of the health of the Mexican population is the priority of the regulatory authority. For this reason, an agile regulation of medicines and supplies that have an impact on people’s health is of the utmost importance.
The regulation carried out by the health authority on medicines and medical devices and the transparency in the exercise of reporting, guarantee access to safe, quality and effective health products.
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