The bill sets forth clear guidelines for the management, processing, and utilization of tissues, cells, and other human-derived components, encouraging their use in the development of biological medicines, cell therapies, and advanced diagnostic tools. According to the legislative text, the Ministry of Health and INVIMA will be responsible for regulation, inspection, and oversight, ensuring high standards of biosafety, quality, and transparency.
Among the most notable elements of the initiative are the prioritization of authorizations for Spin-off companies emerging from universities and research centers, as well as the requirement for Good Manufacturing Practices (GMP) certifications. Furthermore, the bill provides for the creation of a national technological platform to register and monitor the use of these materials, promoting traceability, accountability, and public trust.
Senator Flórez emphasized that this law would position Colombia at the forefront of precision medicine and advanced therapies, strengthening cooperation among academia, the government, and the private sector. If approved, this regulation could represent a key step toward technological self-sufficiency in health, the sustainable use of biological resources, and the generation of high-impact knowledge for the benefit of the population.
