The Social Security Fund (CSS) clarified its position regarding the concerns of the Federation of Patients with Critical, Chronic, and Degenerative Diseases (FENAECCD) about the tenders for biological and biosimilar drugs. The institution highlighted that the planned tenders are conducted under a solid regulatory framework and with stricter quality standards than the regional ones, built with contributions from patient associations, technical guilds, and clinical specialists. CSS recalled that the processes are supervised by the National Directorate of Pharmacy and Drugs and aligned with Law 419 of 2024 and Executive Decrees 27 of 2024 and 12 of 2025, which guarantee quality, traceability, and therapeutic safety. Among the requirements demanded from suppliers are certifications from high-standard regulatory authorities (FDA, EMA), Pharmaceutical Product Certificate, manufacturer identification, safety and efficacy studies for biological and innovative drugs, and the Manufacturer's Solidarity Commitment Letter. The entity warned that introducing requirements outside the current regulations would put the integrity of the process and the drug supply at risk. It reaffirmed its commitment to ensuring safe, effective, and timely products, prioritizing patients.
