The Federal Commission for Protection against Health Risks (Cofepris) issued a call for pharmaceutical companies to own Vaccines against COVID-19 can market their immunization products on the national market.
By a statement that Cofepris explained that the call is aimed at those pharmaceutical companies interested in starting the transition of vaccines “Emergency approval” A “Health Register”.
- The data: In 2020, regulators around the world implemented this “Emergency approval”. This as a temporary tool that made vaccines against it possible COVID-19 Quality, safety and effectiveness in record time.
Cofepris explained that “this is an unprecedented regulatory process” due to its technical complexity and exemplary due to the transparency that the Mexican authority will implement through the “glass box” principle that allows the population to know every step. of the approval process.
What should pharmaceutical companies do?
Before you get the health registration, you can market it vaccine against COVID-19, Pharmaceutical companies must verify the quality, safety and effectiveness of the protocols. These are assessed by experts who specialize in pharmaceuticals. biological and biotechnological.
With this process regulatory pioneer in the world, Cofepris reiterated its commitment to being an agile, fair and transparent health authority. Focuses on protecting people’s health and ensuring access to healthcare with high quality standards.
It was also stated that in accordance with the decree, the end of the health emergency is declared COVID-19the permissions of the Cofepris for medicines and vaccines provided under the National vaccination policy They are still valid and will continue to be universal and free.
The health authority urged the population not to use vaccines indiscriminately COVID-19 as it needs to be taken into account Risk-benefit every application.
Companies must refrain from any attempt to intervene directly or indirectly in the evaluation of the drug.