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:

Purpose and Scope

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.

Main Amendments:

1. Certification and Compliance Enhancements:

   • Revised procedures for obtaining, renewing, and modifying certifications, including stricter documentation and validation requirements.
   • Introduction of transitional provisions allowing microenterprises and small businesses to undergo certification without inspection fees for a three-year period.

2. Operational Standards and Safety Measures:

   • Reinforced 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 establishments outsourcing storage, distribution, or transportation, mandating formal notification to ARCSA, supported by signed contracts with certified third-party providers.
   • Requirements for transparency and traceability in subcontracted services, ensuring alignment with regulatory norms.

4. Updated Definitions and Repealed Sections:

   • Inclusion of new terms like “Notification of Contracted Services”, describing obligations for facilities using external service providers.
   • Repeal of outdated sections, including those related to certifications issued by accredited inspection bodies, as ARCSA assumes direct responsibility for certifications.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 (for applicable products), and storage conditions.
   • Temperature-controlled products must have documented proof of compliance across 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 review the regulation thoroughly, which can be found here (in Spanish).

The National Agency for Regulation, Control, and Sanitary Surveillance (ARCSA) in Ecuador has released Version 2.0 of the External Instruction Document, detailing updated requirements for the registration, re-registration, and modification of sanitary notifications for industrial hygienic products, hospital disinfectants, and food-grade disinfectants. 

Expanded Scope and New Product Categories

The latest version introduces additional product categories under regulation:

• Hygienic disinfectant products for hospital use.
• Food-grade disinfectants. 

New Labeling and Reference Codes

To facilitate compliance, the guidelines now include a dedicated labeling guide for all regulated products:

• Industrial use: Reference Code N129PHI
• Hospital use: Reference Code N129PHHOP
• Food-grade use: Reference Code N129PHFV

This structured approach aims to simplify product identification and regulatory processes for manufacturers and importers.

Enhanced Compliance Requirements

Version 2.0 introduces stricter standards for product efficacy and stability studies:

• Efficacy Studies: Applicants must justify the properties of their products through comprehensive efficacy data.
• Stability Studies: The document mandates stability tests for three distinct product batches, alongside accelerated stability studies adhering to the latest norms.

These changes reflect ARCSA's focus on ensuring product safety and maintaining quality standards throughout a product’s lifecycle.

Evolution of Guidelines

The original guidelines were created in June 2020, but significant updates in December 2024 reflect an ongoing effort to improve regulatory oversight. Key changes include:

• Updated government branding on official documents.
• Clearer processes for modifying sanitary notifications.
• New labeling and study requirements to align with international best practices.

Regulatory Transparency and Accessibility

ARCSA emphasized that this document is solely for its intended purpose and that stakeholders must always consult the latest version available in the institutional repository. Printed or copied versions are considered uncontrolled and may lack the most recent updates.

A Step Forward in Hygiene and Safety

The revisions aim to streamline the registration process, enhance public safety, and provide clarity to stakeholders navigating the regulatory landscape. The agency encourages manufacturers, importers, and distributors to familiarize themselves with the updated requirements and ensure full compliance by referencing the institutional repository. For further details, External Instruction Document can be found here (in Spanish).