In the dynamic world of the healthcare industry, venturing into new markets presents both exciting opportunities and unique challenges. Understanding the intricacies of the evolving landscape of the healthcare system, intellectual property rights, and regulations within each country or region is indispensable for success.
Colombia offers a diverse landscape for growth but requires an expert approach to navigate its regulatory framework effectively.
For instance, recent adjustments to the structure of INVIMA (the Colombian FDA) in Agreements 7 and 8 of 2024 involve changes in the profile of the commissioners of the technical advisory board and an increase in the number of INVIMA officers. These adjustments aim to address the problem of backlogs in Marketing Authorization and other related proceedings.
Additionally, Circular 18 of 2024 by the National Commission for Medicine and Medical Devices Prices (NCMMDP) sheds light on changing pharmaceutical pricing regulations.
It evidences the need for a comprehensive understanding of the criteria for assigning a drug to either the surveilled freedom or direct control regimes. Factors such as foreign prices and the methodology for international referencing play a crucial role in calculating the maximum sales value for Colombia.
Ongoing changes in the healthcare system must be continuously monitored to identify new opportunities and identify potential risks to businesses.
Navigating Colombia’s regulatory landscape requires more than surface-level knowledge; it demands the expertise of local professionals who understand the nuances and can guide companies through the intricacies.
In conclusion, as Colombia continues to shape its regulatory environment to align with global standards, companies must invest in local expertise to capitalize on opportunities, streamline processes, and effectively mitigate risks.
