BioPhorum feedback on Columbia decree
This member only content is the Colombia decree consolidated feedback that BioPhorum organized with the biomanufacturers involved in Post Approval Change Management workstream, Colombia sub-team.
As a result of the appointment of a new health minister, there were changes to three Columbian decrees. The team consolidated the feedback of the new decrees in comparison with WHO guidelines for biologics with the aim of encouraging harmonization of these decrees with the WHO guidelines and therefore other markets and the rest of industry. All moves towards this improve our agility and prevent delays or potential patient outages.
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