Colombia Moves to Finalize Medicinal Cannabis Regulations by March

The national government and health authorities are currently working to define the technical framework that will govern medical cannabis in Colombia.

The National Institute for Food and Drug Surveillance (Invima) has until next March to finalize the regulations that will give definitive shape to this industry, in a context of high expectations for both the health system and the market. The urgency is significant: globally, the sector projects revenues of $26.92 billion by 2026, after closing 2025 with more than $21.83 billion, figures that position medicinal cannabis as a rapidly expanding business.

Colombia advances new regulations to strengthen medicinal cannabis oversight, boost medical confidence, and position the country in the rapidly growing global market

The regulatory roadmap in Colombia is based on Decree 1138 of 2025, a regulation that seeks to address persistent gaps and provide legal certainty to a sector that, despite its growth, has been marked by ambiguity. With the issuance of new technical standards, the Government and Invima aim to strengthen the confidence of physicians and patients, eliminate legal gray areas, and consolidate Colombia as an exporter of finished products, beyond simply supplying raw materials.

The authorization granted allows the company to produce and ship psychoactive extracts as part of the extracts agreement announced in January of this year, destined for the German market.

From the industry perspective, the emphasis is on strengthening clinical confidence. Juan Romero, CEO of Carmen’s Medicinals, explains that the core of the regulation will be updating packaging, dispensing, and quality control procedures, as well as establishing mandatory analytical standards for cannabinoids such as THC and CBD. The goal, he states, is for cannabis derivatives to cease being viewed as alternative therapies and to be fully integrated into conventional medical practice, with the same scientific and regulatory rigor as any chemically synthesized drug intended for medicinal use.

Before the March deadline, Invima must finalize eight critical guidelines that will govern the sector’s operations

These include defining Good Manufacturing Practices (GMP) for compounded medications; adopting supplementary guidelines for clinical trials; and establishing clear rules for low-risk products or those containing non-psychoactive cannabinoids. In addition, the process for dispensing and delivering medications to patients in Colombia must be updated, inspection and surveillance protocols must be created, and strict regulations on labeling and advertising must be implemented to prevent misleading messages or unsubstantiated therapeutic claims.

A central component of the new regulatory framework in Colombia will be full product traceability. To achieve this, interoperability with the Ministry of Justice’s SEED system will be implemented, allowing the plant to be tracked from cultivation to its arrival at the patient. This control aims to close any gaps in the supply chain and strengthen health surveillance, a key aspect for building trust with both the medical community and end users.

According to the executive at Carmen’s Medicinals, one of the main challenges the regulations aim to address is the reluctance of healthcare professionals and the distrust of patients, stemming from years of regulatory ambiguity in Colombia. The new regulations directly target this legal and clinical uncertainty by eliminating gray areas and fully implementing Decree 1138. This reduces doubt regarding medical responsibility and the type of evidence required for prescription, ensuring that the use of medicinal cannabis has explicit state support.

Quality control will be another cornerstone of the new system in Colombia

In this same vein, Invima will precisely define which products are suitable and for which specific pathologies, establishing indication criteria that reduce the risk of unsafe use. This safeguard will be complemented by unified prescription and monitoring protocols, while the Ministry of Health will update the technical guidelines on dosage, contraindications, and discontinuation criteria, with the aim of standardizing care throughout Colombia.

Quality control will be another cornerstone of the new system in Colombia. The regulations will require that medicinal cannabis maintains the same potency and ingredients in every bottle, without variations that could compromise the treatment. Furthermore, the labeling must provide clear information about how the medication works and its potential risks, under conditions similar to those of any pharmaceutical product available in a pharmacy.

For the industry, this regulatory package represents a turning point. On the one hand, it offers the scientific and legal backing that physicians have demanded to prescribe safely; on the other, it lays the groundwork for Colombia to consolidate its position as an exporter of finished products in a rapidly expanding global market. With March as the deadline, Invima faces the challenge of completing the regulatory cycle and translating expectations into clear rules that define the future of medicinal cannabis in the country.

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(Featured image by Jhonny Estrada via Unsplash)

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First published in EL TIEMPO. A third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.

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