2023-07-21 18:00:25
During the first half of July 2023, Cofepris authorized 139 health supplies: 109 medical devices, 23 new drugs, and 7 clinical trials.
Within medical devices, 55 are for medical care, 28 medical equipment, and 26 for diagnosis.
The Commission regulates 44 cents of every peso spent by households in Mexico and the figure is obtained through three sectors that it regulates: food, beverages and tobacco; health care articles; and personal care items.
For the authorization of new medicines in Mexico it is necessary to abide by a strict process regulated by the Federal Commission for the Protection against Sanitary Risks (Cofepris). The objective is not only to verify its correct functioning, but also that it does not generate serious adverse effects.
For its part, one of the recent actions to keep the population informed is to publish the work done on this matter every fortnight. Furthermore, it covers not only drugs but also devices and other types of inputs related to health.
With this in mind, in the report corresponding to the first two weeks of July 2023 it was announced that the Cofepris authorized 23 new medicines, 109 medical devices and seven clinical trials.
The new health registrations issued to medical devices are divided into 55 for medical care. For example, transcatheter heart valve, coronary dilatation balloon catheter, cervical fixation systems, and synthetic bone substitute.
To these supplies are added 28 medical teams, of which the following stand out: extracorporeal blood pump, orthopedic surgical instruments and thromboelastograph. In addition to 26 diagnostic medical devices for the detection of cytomegalovirus, thyroid hormones, ethanol, among others.
New drugs approved by Cofepris
Regarding the therapeutic expansion of drugs, 23 drugs were authorized, among which are: alpelisib, for attention to breast cancer; atogepant, preventive treatment for episodic migraine; and clevidipine, for systemic arterial hypertension. The complete list can be consulted at this link.
Of the new authorizations in terms of clinical trials, two stand out for the search for new treatments for cancer; one for uveitic macular edema; one for axial spondyloarthritis; and one for hidradenitis suppurativa.
Creation and relevance of Cofepris
First of all, it is necessary to remember that the cofepris was born in 2001. From the beginning it was established that it would be a decentralized administrative body of the Ministry of Health (SSa), with technical, administrative and operational autonomy. Its main task is to be the governing body in the field of health control and regulation throughout the country.
Since then, it has been in charge of analyzing and authorizing the operation of all health-related products, devices and establishments. It ranges from pharmaceutical laboratories, medicines, pharmacies and offices of all kinds. In sum, all of them are equivalent to almost 10 percent of the Gross Domestic Product (GDP).
According to current calculations, Cofepris regulates 44 cents of every peso spent by households in Mexico. The figure is obtained through three sectors that it regulates: food, beverages and tobacco; health care articles; and personal care items.
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