The Social Security Fund (CSS) clarified its position regarding concerns raised by the Federation of Patients with Critical, Chronic, and Degenerative Diseases (FENAECCD) about the tenders for biological and biosimilar medicines. CSS reaffirmed its commitment to quality, safety, and transparency in the acquisition of biological and biosimilar medicines. It reaffirmed its commitment to ensuring safe, effective, and timely products, prioritizing patients. CSS reminded that the processes are under the supervision of the National Directorate of Pharmacy and Drugs and are 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 of bidders are certifications from high-standard regulatory authorities (FDA, EMA), Pharmaceutical Product Certificate, manufacturer identification, safety and efficacy studies for biological and innovative products, and the Manufacturer's Solidarity Commitment Letter. The institution highlighted that the tenders scheduled for December are carried out within a solid regulatory framework and with stricter quality standards than in the region, built with contributions from patient associations, technical guilds, and clinical specialists. The entity warned that introducing requirements outside of current regulations would jeopardize the integrity of the process and the supply of medicines.
Panama's CSS reaffirms quality and safety of medicine procurement
Panama's Social Security Fund clarified its position on biological medicine tenders, reaffirming commitment to quality, safety, and transparency. Processes are conducted under strict supervision and comply with all regulatory requirements.
