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The Ecuadorian National Agency for Regulation, Control, and Health Surveillance (ARCSA) has issued a resolution introducing new reforms to the technical sanitary regulations for the registration of health products. The reform, which is part of a broader initiative to streamline administrative processes. 

The resolution, ARCSA-DE-2025-xxx-DASP, is built upon the Ecuadorian Constitution's commitment to public health and the authority granted to the nation's health agency. This includes maintaining conformity with national laws and international treaties, such as the Andean Decision 833, which mandates mandatory sanitary notifications for cosmetic products. 

Key Changes Introduced:

1. Product Certification and Documentation Requirements:
   The updated regulations call for more robust documentation for product registration and sanitary notification. Among the mandatory requirements are technical product sheets and manuals, which must include key details such as product names, intended uses, specifications, and production processes. For some products, especially medical devices, additional certifications and approvals are necessary, including those from the Comité de Ética de Investigación en Seres Humanos (CEISH) for in-vitro research use products.

2. New Definition for In-Vitro Use Products:
   In a significant update, a new definition for "Research Use Only" (RUO) products has been added to the regulatory framework. These products, intended solely for scientific or technological research, will now require specific documentation to ensure they are not used for clinical or diagnostic purposes. This includes manufacturer certifications, technical inserts, and ethical approval from research committees.

3. Enhanced Procedures for Registration:
   The resolution also introduces clearer procedural steps for obtaining sanitary certification. Applicants must submit their product documents via the Ventanilla Única Ecuatoriana (VUE), Ecuador's online platform for regulatory submissions. The process includes an official payment order and a defined timeline for submission and correction of any issues that arise during the review.

4. Streamlined Importation Controls:
   Products imported into Ecuador will now face more streamlined controls, with up to 10 products allowed per registration application if they share the same classification. This change is part of a broader effort to facilitate trade while maintaining high standards of product safety.

5. Monitoring and Future Reforms:
   The ARCSA has been tasked with continually reviewing the impact of these regulations, ensuring they align with national goals for economic competitiveness and transparency in regulatory procedures. The Comité de Comercio Exterior (Foreign Trade Committee) is empowered to periodically assess the implementation and efficiency of the new regulatory framework.

6. New Product Documentation Guidelines:
   The reform has introduced detailed guidelines for the documentation required for products, including:

   • A technical sheet or user manual detailing product specifications, intended uses, and more.

   • A certificate of origin and clinical studies where applicable.

   • Raw material analysis documentation, which should include sanitary notifications or certificates as evidence for the use of such materials in product manufacturing.

   • For medical devices and in-vitro products, manufacturers must include specific compliance documents, such as ethical approvals and institutional certifications.

7. Public Consultation on the Reform:
   In line with Ecuador's commitment to transparency and stakeholder engagement, the public consultation period for the reform will run from July 4, 2025 to August 1, 2025. During this period, stakeholders can submit their observations through the designated collection format via email at consulta.normativa@controlsanitario.gob.ec. This initiative ensures that the public, industry professionals, and other stakeholders have a chance to contribute feedback on the new regulatory changes before they are finalized.

In a major regulatory move aimed at strengthening public health safeguards, the National Agency for Regulation, Control, and Sanitary Surveillance (ARCSA) has issued Resolution ARCSA-DE-2024-058-DASP, enacting new technical regulations for the registration, control, and surveillance of general-use medicines. The regulation will officially enter into force on June 30, 2025. This resolution aligns with Ecuador’s constitutional mandate to guarantee access to safe, effective, and high-quality medicines, reinforcing compliance with international standards set by the World Health Organization (WHO) and the Andean Community (CAN).

Key Highlights of the New Regulation:

• Mandatory Registration: All pharmaceuticals intended for human use must obtain and maintain a sanitary registration certificate to be legally manufactured, imported, or sold in Ecuador.

• Stricter Quality Controls: Comprehensive guidelines have been introduced for good manufacturing practices (GMP), bioequivalence studies, and pharmacovigilance.

• Fast-Track Approvals: Medications already approved by WHO-recognized authorities may qualify for an expedited homologation process.

• Enhanced Post-Market Surveillance: ARCSA will conduct routine inspections and laboratory analyses to verify compliance with safety and quality standards.

• Labeling and Transparency Requirements: Pharmaceutical companies must adhere to updated guidelines on packaging, labeling, and patient information leaflets, ensuring clear and accurate information is available to consumers.

The resolution will take full effect on June 30, 2025, six months after its signing on December 30, 2024. ARCSA has urged all stakeholders in the pharmaceutical industry, including manufacturers, importers, and healthcare providers, to adapt to these changes to enhance Ecuador’s public health framework. For further details, you can find the Resolution here (in Spanish).