- Biotech medicines are innovative pharmaceutical products made from living organisms.
- These drugs are used to treat autoimmune diseases, certain types of cancer, rare diseases, and genetic disorders, among others.
- Currently, most of the drugs of this type that are consumed in Mexico are manufactured abroad.
As part of the Regulatory Certainty Strategy for the Pharmaceutical Sector, the Federal Commission for Protection against Sanitary Risks (Cofepris) released a new project. Through various health promotion actions, it seeks to guarantee that the population of Mexico and the countries of the region have access to quality biotechnological medicines and biosimilars.
This health authority aspires to achieve innovation through various plans and projects, among which stands out potentiate in the pharmaceutical industry established in Mexicothe production and development of biotechnological and biosimilar medicines, the importance of which will continue to grow as we move into the era of personalized medicine.
The biotech drugs they are innovative pharmaceuticals, made from living organisms that offer more effective and less toxic treatments for a wide range of diseases. These drugs are used to treat autoimmune diseases, certain types of cancer, rare diseases, and genetic disorders, among others.
Achieve more and better medicines
To materialize this project, the collaboration of the private and academic sectors is essential. For this reason, Cofepris convened representatives of both sectors and presented the general strategy, while establishing a permanent working group that will be headed by this authority, in favor of the development of innovative therapies in Mexico.
This meeting represented the beginning of long-term vision and collaboration. It was proposed that the academy, as well as the regulatory and regulated entities, establish the key areas to review, such as the improvement of the regulatory framework applicable to this type of product, considering the life cycle in a comprehensive manner and the recommendations of international organizations such as the World Health Organization (WHO) o Pharmaceutical Inspection Cooperation Scheme (PIC/S) Guidelines.
Most of today’s biotech drugs are manufactured abroad
Currently, the The majority of biotechnologicals and biosimilars consumed in Mexico are manufactured abroadTherefore, effective regulatory coordination is required so that these high-quality medicines are available in the national market, through actions that promote the health self-sufficiency of the country and the region.
This strategic project promises not only to transform the medical landscape, but also to strengthen the national economy. By encouraging each sector, from its trenches, to contribute to the promotion of biotechnologicals, we are tracing a path towards scientific and technological excellence, guaranteeing safety, certainty and regulatory efficiency.
The Mexican pharmaceutical sector, in its different stages, and especially during the recent COVID-19 pandemic, has shown that it has the necessary tools to excel in the manufacture of innovative, safe, effective and high-quality medicines.
The Regulatory Certainty Strategy for the Cofepris Pharmaceutical Sector promotes the manufacture of biotechnological and biosimilar medicines in Mexico, with the purpose of contributing to the health self-sufficiency of our country and the Latin American and Caribbean region. The actions towards its implementation not only expand the therapeutic offer, but, more importantly, improve the quality of life of people through innovative treatments and products.
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