2023-08-22 22:00:47
Cofepris was born in 2001 and from its conception it was established as a decentralized administrative body of the Ministry of Health.
In addition to the authorization of the 24 new drugs, there are also 121 devices such as thrombectomy and coronary angioplasty catheters, as well as surface-mounted bone vibration digital hearing aids.
A clinical trial has also been approved to verify the efficacy of lenacapavir in HIV pre-exposure prophylaxis in persons 16 years of age and older.
Health is one of the bases within any government because it has a direct relationship with the integrity of all people. At the same time, it is one of the most closely watched sectors due to its relevance. For the authorization of new medicines the Federal Commission for the Protection against Sanitary Risks (Cofepris) is the maximum in charge in the matter.
Its creation took place in 2001 and from its conception it was established as a decentralized administrative body of the Ministry of Health (SSa). Its main task is to be the governing body in the field of health control and regulation throughout the country.
With this in mind, absolutely all health-related products, devices and establishments must have authorization to operate in Mexico. The same goes for the pharmaceutical laboratories, medicines, pharmacies and offices of all kinds.
For its part, the impact of this Commission is so great that regulates 44 cents of every peso spent by households in Mexico. The reason is because the three sectors it regulates are food, health care items, and personal care items.
Cofepris authorizes new medicines
For its part, as part of its daily activities, Cofepris publishes a biweekly report regarding its work. The most recent edition indicates that a total of 151 health supplies were approved.
The detailed information includes six new clinical trials, including one for to assess the efficacy and safety of long-acting lenacapavir. It is indicated to be administered subcutaneously twice a year and works for pre-exposure prophylaxis to HIV in people 16 years and older who are at risk of infection.
Pre-exposure prophylaxis (PrEP) is a preventive treatment for HIV transmission, which protects populations at higher risk of acquiring it. It consists of taking, daily and on a scheduled basis, a drug that generates protection in the person’s body to reduce the chances of acquiring the virus in case they are exposed to it.
Cofepris authorizes 151 new health supplies; highlights clinical trial of pre-exposure prophylaxis for HIV.#CofeprisTransparente
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— COFEPRIS (@COFEPRIS) August 22, 2023
The report also reports the authorization of 24 new drugs. Within the list there is a new molecule for the treatment of chronic myeloid leukemia and an innovative biotechnological agent against anemia. The complete list with all the new medicines approved by Cofepris can be consulted at this link.
New medical devices authorized for use in Mexico
In addition, a total of 121 medical devices were authorized, of which 32 are dedicated to medical care. In the list stand out thrombectomy and coronary angioplasty catheters, as well as bone-surface vibration digital hearing aids.
Among these inputs there are 59 new devices to diagnose toxoplasmosis, carbapenemase, and to measure the sensitivity of slow-growing non-tuberculous mycobacteria. There are also 30 new medical equipment, such as spectroscopy and intravascular ultrasound, and a Loop-X mobile imaging robot.
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