Regulatory Affairs Leaders in LATAM - 66 Observations Colombia Draft

We filed 66 formal observations to Colombia's draft clinical research Resolution. Not suggestions. Not a comment letter. Sixty-six line-by-line observations across five regulatory themes, submitted during the public consultation window to MinSalud. Most CROs read a new regulation after it passes and figure out how to comply. We read the draft while it was still open for input and told the regulator what needed to change. Theme 1 was risk-proportional review. The draft treated every study the same regardless of risk level. We proposed a low-intervention category and mandatory expedited pathways tied to actual risk, not institutional discretion. Annual reporting for every study regardless of complexity violates proportionality, and we said so. Theme 2 was timelines. The draft had no deadlines for INVIMA approvals or ethics committee decisions. No consequence for inaction. We proposed parallel review and administrative-silence rules so that sponsors are not held hostage by bureaucratic delay. Theme 3 was data protection. The draft created a conflict between deleting participant data on withdrawal and the scientific-integrity duty to preserve trial records. We proposed ISO 27001 standards and keeping the SIC as the competent data authority. Themes 4 and 5 addressed contradictory vulnerability definitions, overly rigid consent rules, and duplicative ethics reviews in multicenter studies. This was the most comprehensive formal response bioaccess® has ever made to a LATAM regulatory consultation. Because shaping regulation is part of the work. If you only react to rules after they are written, you are already behind. If you are a regulatory affairs leader, clinical operations director, or principal investigator working in LATAM clinical research, I want to hear your perspective on the Global Trial Accelerators™ podcast. DM me or comment below to be a guest. #ClinicalTrials #Colombia #LATAM #RegulatoryAffairs #MedTech #MedicalDevices #bioaccess