Ecuador Implements New Sanitary Technical Regulations for Medicines

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).