The document outlines the updated regulatory framework and safety standards for the extraction, processing, and distribution of blood-derived medicinal products in Colombia, ensuring these products meet national and international quality and safety requirements.
This document covers the following information:
- Public consultation begins on 24-Mar-2026, and ends on 09-Apr-2026
- Legal basis and policy reasons for regulating blood-derived medicinal products to protect public health
- International recommendations and standards (such as those from the WHO) for the safe collection, processing, and use of plasma and serum for medicinal products
- Requirements for Good Blood Practices (GBP) and the traceability of plasma used in manufacturing medicinal products
- The importance of advanced testing, such as nucleic acid amplification tests (NAT), to prevent the transmission of infections through plasma-derived products
- The new classification and oversight of facilities involved in producing plasma and serum-derived medicinal products
- The promotion of domestic production and self-sufficiency in blood-derived medicines as part of Colombia’s health sovereignty strategy
- The clear definition of roles and responsibilities for institutions involved in the supply chain for blood-derived medicinal products
- Measures to ensure quality, safety, and accountability at every stage from donation to product distribution
- The alignment of local regulations with international standards to enable Colombia’s recognition as a reliable authority in blood-derived products
- This decree will be published in the Official Gazette and will come into effect eighteen (18) months after publication, at which time Decree 1571 of 1993 and all other provisions that conflict with it will be repealed
Source
Select Mandate HA
Select Mandate Function