Medicinal Products

Drug Product Registration in Colombia – Overview

The National Institute for Food and Drug Surveillance (INVIMA) is Colombia’s national health authority responsible for regulating and supervising medicines and other health-related products.

INVIMA protects public health by overseeing the safety, quality, and efficacy of pharmaceutical products, as well as by monitoring risks associated with their manufacture, importation, commercialization, and use. INVIMA carries out its functions through regulatory control, surveillance, and sanitary oversight actions, in accordance with Colombian health regulations and aligned with international best practices.

These activities are supported by scientific evidence, technical expertise, and a risk-based regulatory approach, in coordination with other national health authorities. Through its specialized technical areas, INVIMA plays a central role in the evaluation and authorization of medicinal products, granting marketing authorizations and ensuring ongoing compliance throughout the product lifecycle in the Colombian market.

Classification of Medicinal Products in Colombia

In Colombia, the regulations of the National Institute for Food and Drug Surveillance (INVIMA) classify drugs into the following categories:

• Chemical Drugs (Small Molecules): Includes different drug classes based on their composition and therapeutic use.
• Biological Products:
  • Preventive Biologicals (vaccines and other immunization products).
  • Therapeutic Biologicals (monoclonal antibodies, recombinant proteins, among others).
• Herbal and Natural Products: Medications derived from natural sources with therapeutic properties.

Medicinal Product Registration in Colombia

The National Institute for Food and Drug Surveillance (INVIMA) regulates the drug registration process in Colombia. The classification of a pharmaceutical product determines the applicable regulatory pathway.

Foreign companies seeking to commercialize pharmaceutical products in Colombia must appoint a local authorized representative responsible for regulatory affairs and the registration process with INVIMA.

For imported drugs, the approval process includes obtaining a Sanitary Registration, which requires submitting a technical dossier that includes:

• Administrative and legal documentation (application form, cover letter, labeling, clinical trial information –if applicable – GMP and CPP certifications, LOA/POA, among others).
• Quality information (composition, specifications, analytical methods, stability studies, and manufacturing process details).
• Safety and efficacy data (clinical studies, bibliographic references, and safety reports when applicable).

INVIMA performs a comprehensive technical review, including document validation and product name approval. If the process is successfully completed, the Sanitary Registration is granted.

Product Maintenance and Compliance in Colombia:

Following the issuance of Decree 334 of 2022, as amended by Decree 1474 of 2023, marketing authorizations for medicinal products in Colombia now have indefinite validity. As a result, periodic renewal of sanitary registrations is no longer required under the Colombian regulatory framework.

This regulatory shift aims to reduce administrative burdens and enable the National Institute for Food and Drug Surveillance (INVIMA) to focus its resources on post-marketing inspection, surveillance, and control activities, strengthening oversight of the safety, quality, and efficacy of medicinal products available in the market.

However, indefinite validity does not exempt marketing authorization holders from ongoing regulatory obligations. Product maintenance is based on a continuous change management system, under which any relevant modification—including changes to formulation, raw materials, manufacturing process, manufacturing site, packaging, labeling, or storage conditions—must be properly assessed and submitted to INVIMA, as applicable.

Such changes are governed by the “Guideline for Submitting Modifications to Sanitary Registrations with an Impact on the Quality of Chemical Synthesis Medicinal Products” (code ASS-RSA-GU82, version 1, November 3, 2023). This guideline classifies variations according to risk level (minor, moderate, or major) and specifies the technical documentation and regulatory procedure required prior to implementation. Where applicable, it also allows for the grouping of variations, facilitating a more efficient review process.

In practice, the Colombian model shifts regulatory responsibility from a periodic renewal process to a continuous compliance framework, supported by quality evidence and subject to inspection, verification, and audit by INVIMA at any time.

Pharmacovigilance

At Freyr, we are committed to patient safety and regulatory management; therefore, pharmacovigilance constitutes an essential component of our service portfolio, aligned with the requirements of the applicable health regulations in Colombia.

In Colombia, pharmacovigilance activities are regulated by the National Institute for Food and Drug Surveillance (INVIMA). These activities include, among others:

• Receipt, management, and reporting of Individual Case Safety Reports (ICSRs).
• Preparation and submission of Periodic Safety Update Reports / Periodic Benefit-Risk Evaluation Reports (PSUR/PBRER).
• Literature monitoring.
• Development of Risk Management Plans (RMPs).
• Post-marketing surveillance studies.
• Safety signal detection and management.
• Additional pharmacovigilance activities.

All pharmacovigilance activities must be overseen by a duly appointed Local Person Responsible for Pharmacovigilance, before INVIMA.