,2 min read
In Colombia, the process of modernizing the regulatory framework for biological medicines is advancing with concrete steps. On June 24, 2025, INVIMA held a technical roundtable with industry representatives to present the legal and technical guidelines supporting the migration from Decree 677 of 1995 to Decree 1782 of 2014.
This regulatory shift aims to align the country's processes with international standards by establishing differentiated procedures for biological medicines and strengthening key aspects such as traceability, quality, and safety.
What changes with this migration?
During the session, the main differences between the two decrees were explained. Unlike Decree 677, Decree 1782 incorporates stricter technical criteria and acknowledges the specific characteristics of biological products. Key changes include:
- Adoption of the CTD (Common Technical Document) format as the dossier structure.
- Mandatory inclusion of a Risk Management Plan (RMP).
- Requirements to comply with technical guidelines for immunogenicity, stability, and biosimilar comparability.
Additionally, the update of form ASS-RSA-FM110 was announced, along with recommendations for submitting modifications under Decree 334 of 2023. The new form will take effect in July 2025, and will include improvements such as a model protocol for product release.
What is the tentative timeline?
As a result of discussions with the industry, it was proposed that regulatory migration requests be submitted no later than December 31, 2025. Beginning in January 2026, INVIMA would start official reviews for products that have not initiated the modification process. While this proposal was well received, it has not yet been formalized as a mandatory requirement.
What could this process mean for companies in the sector?
This transition is more than just a formatting change or technical update. It requires companies to review their dossiers, adapt internal processes, and align documentation with a new regulatory logic. It also presents operational challenges, such as restructuring Module 3 to meet CTD criteria and updating all five modules of the dossier.
At the same time, it opens a strategic window for companies that anticipate the shift with a holistic regulatory strategy. Aligning with Decree 1782 may not only improve compliance but also accelerate future processes, streamline cross-border submissions, and strengthen technical credibility with the regulatory authority.
Policy Framework Support: The Role of CONPES
This regulatory change is not an isolated decision. It is backed by key public policy documents such as CONPES 3697 (2011), which promotes the development of biotechnology under principles of quality, sustainability, and international convergence, and CONPES 155 (2012), which outlines the national pharmaceutical policy.
From a strategic perspective, these CONPES documents:
- Provide clarity on the regulatory direction of the country.
- Reinforce the view that regulation is not just a requirement, but a tool for competitiveness.
- Validate the role of the private sector and technical-consultative partners in building a more modern and reliable ecosystem.
A Practical Approach for a Changing Environment
Freyr, your technical guide in regulatory transitions
In this context, specialized regulatory support not only facilitates compliance but also helps anticipate trends, assess risks, close gaps, and support informed decision-making. At Freyr, we:
- Review existing dossiers to align with the new Colombian regulatory requirements.
- Support the redesign of regulatory strategies under structured formats such as CTD, enabling a gradual yet consistent transition.
- Assist in complying with specific technical guidelines, integrating risk and opportunity assessment to strengthen companies’ preparedness for more demanding regulatory processes.
Our approach combines local and international expertise, up-to-date regulatory knowledge, and operational capacity to act quickly in evolving regulatory environments.
Does your company manage biologicals in Colombia or the broader region?
Let’s discuss how to prepare with clarity, technical rigor, and minimize unnecessary risks. Contact us.