Ecuador
has three main documents that together establish
the rules for chemical industry in the country:
-
Technical Regulation 078 on transport,
storage, and management of hazardous materials
-
Acuerdo Ministerial 099 on instructions for the registration of
hazardous chemical substances and environmental obligations
-
Decreto 752/2019 that states the creation of a chemical
inventory and a chemical registry
Additionally, Ecuador is
part of the Andean Community, which indicates that the communal regulation for
chemical pesticides for agriculture is in place (Resolución 2.075/2019).
Jan-29-2025
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).
Jan-24-2025
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 through 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 stakeholders have adequate time to comply.
Key Details of the New Sanitary Technical Regulation:
The updated regulation emphasizes modernizing certification procedures, reinforcing operational requirements, and ensuring compliance obligations for establishments engaged in the storage, distribution, and transportation of pharmaceutical products and medical devices. It aligns with international best practices to protect public health and improve regulatory oversight.
Certification and Compliance Enhancements:
Operational Standards and Safety Measures:
Third-Party and Subcontracting Processes:
Updated Definitions and Repealed Sections:
Audit and Inspection Framework:
Labeling and Traceability Improvements:
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 review the regulation thoroughly, which can be found here (in Spanish).
Global Product Compliance (GPC) specializes in Global Regulatory Compliance Solutions across sectors
globally. SSS Europe, a familiar name in chemical regulatory and compliance services now formally belongs
under the umbrella of GPC Holding Sweden.
Since 2008, we have emerged as one of the leading names among Global Regulatory Compliance Service
Providers with Representation services in Europe, Asia and Middle East for respective chemical
regulations.
© Copyright 2025 | Global Product Compliance