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). 

The Republic of Ecuador has announced significant amendments to its Sanitary Technical Regulation on Good Practices for Storage, Distribution, and/or Transportation for pharmaceutical companies and manufacturers of medical devices for human use. This update is formalized by Resolution No. ARCSA-DE-2024-047-DASP, issued by the National Agency for Sanitary Regulation, Control, and Surveillance (ARCSA) on December 12, 2024. The regulation will take effect six months after its signing, as stipulated in the addendum from the Ministry of Production, Foreign Trade, Investment, and Fisheries, ensuring that stakeholders have sufficient time to comply.

Key Details of the New Sanitary Technical Regulation:

Purpose and Scope of the Updated Regulation

The updated regulation focuses on modernizing certification procedures, strengthening operational requirements, and ensuring compliance obligations for establishments engaged in the storage, distribution, and transportation of pharmaceutical products and medical devices. It is aligned with international best practices to protect public health and improve regulatory oversight.

Key Amendments in Certification Procedures:

1. Certification and Compliance Enhancements:

   • Revised procedures for obtaining, renewing, and modifying certifications, including stricter documentation and validation requirements.

   • Introduction of transitional provisions allowing micro and small enterprises to undergo certification without inspection fees for a period of three years.

2. Operational Standards and Safety Measures:

   • Increased emphasis on temperature control and environmental mapping, requiring facilities to monitor and document conditions for at least seven days during initial validation and repeat the process every three years.

   • Enhanced requirements for security measures to prevent unauthorized access to storage facilities.

3. Third-Party and Subcontracting Processes:

   • Clear guidelines for facilities that outsource storage, distribution, or transportation, mandating formal notification to ARCSA, supported by signed contracts with certified third party providers.

   • Requirements for transparency and traceability of subcontracted services, ensuring compliance with regulatory norms.

4. Updated Definitions and Repealed Sections:

   • Inclusion of new terms such as “Notification of Contracted Services”, describing the obligations of facilities using external service providers.

   • Repeal of outdated sections, including those relating to certifications issued by accredited inspection bodies, as ARCSA assumes direct responsibility for certifications.

5. Audit and Inspection Framework:

   • Mandatory periodic audits during the validity of certifications to verify adherence to Good Practices and the conditions under which certifications were granted.

6. Labeling and Traceability Improvements:

   • New requirements for product labeling, specifying details such as product name, batch/lot number, expiration date (where applicable), and storage conditions.

   • Temperature-controlled products must have documented proof of compliance throughout the supply chain, including transportation.

Implementation Timeline

The Regulation will enter into force on June 12, 2025, ensuring a structured transition period. This timeline allows stakeholders to adapt their operations to the new requirements.

This amendment reflects Ecuador’s commitment to enhancing its regulatory framework for pharmaceuticals and medical devices. Stakeholders are advised to thoroughly review the regulation which can be found here (in Spanish).