Mexico City. To grant sanitary registrations to medicines manufactured abroad, the Federal Commission for the Protection against Sanitary Risks (Cofepris) will accept the interchangeability tests carried out in the United States, Canada, Switzerland, Australia, Japan, among others. These studies prove that the products meet the quality, safety and efficacy requirements.
Specifically, that generics have the same result in the treatment and control of diseases, with respect to innovators.
The Official Gazette of the Federation today publishes an emergency modification to the Official Mexican Standard (NOM) 177-SSA1-2013, in order to facilitate the entry of medicines from abroad.
The interchangeability tests are part of the requirements to obtain the sanitary registration. This measure is in addition to previous provisions ordered by the head of the Executive Power to expedite the procedures and in relation to foreign products, which are concluded within a period of five days.
The foregoing, within the framework of the international tender organized by the United Nations Office for Project Services (UNOPS) and of which it is still pending to publicize the rulings and the assignment of contracts to suppliers of medicines and healing materials for the remainder of the year.
The process has had a series of delays since the end of last year and the latest information available is that deliveries of the medicines would begin “in a staggered manner” as of May.
Now, the emergency modification of the NOM indicates that the interchangeability tests, if they are carried out in national territory, must be carried out by authorized third parties, while for foreign-manufactured drugs, “interchangeability or biocomparability studies that have been carried out in the country of origin and must present in their extension the interchangeability tests carried out by Authorized Third Parties in the national territory with the Mexican population ”.
In the report on the Covid-19 pandemic in the country this Monday, it was reported that 139 thousand 158 vaccines against Covid-19 were applied on Sunday, with which the accumulated figure stood at 18 million 471 thousand 669. Of the total, 7 million 792 thousand 707 correspond to people who already have the complete scheme of one or two doses
Hugo López-Gatell, Undersecretary of Prevention and Health Promotion, reported that among older adults, 6 million 34 thousand 559 have full protection of biologicals, as well as 842 thousand 990 health workers and 915 thousand 158 members of the sector education in the country.
He said that although the national vaccination plan continues to advance, it is not at the speed “we would like” for lack of biologicals. He explained that these are produced in a few countries and only those who bought in advance, such as Mexico, are receiving them. Still, the delivery process has been slow.
He recalled that this Monday began the application of the first doses to people who are 50 years and older.
On the behavior of the Covid-19 pandemic, this day’s report indicates that in the past 24 hours 110 deaths were confirmed, for a total of 217 thousand 345. Active cases are 20 thousand 527, they represent less than one percent of people estimated to have had the infection.
José Luis Alomía, director of Epidemiology of the Ministry of Health, indicated that one million 872 thousand 375 individuals have recovered, while the trend of the epidemic curve accumulates 15 weeks of decline. In week 16 (from April 18 to 24) the reduction in infections was 13 percent compared to the previous week.
Regarding hospitalization, the official commented that it is also decreasing. Today 12 percent of general beds are occupied and 15 percent of those with a fan.
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