Modernizing Pharma Regulations: Exclusivity for New Chemical Entities

On March 10, 2025, a partial reform to Resolution ARCSA-DE-2024-023-DASP was published in the Official Register. This resolution regulates the Exclusivity Period for Test Data for Pharmaceutical Products containing New Chemical Entities. This update is fundamental for the pharmaceutical sector, as it ensures the protection of investment in the research and development of new medicines in Ecuador.

Context and Challenges of the Previous Regulation

The original regulation, issued on June 28, 2024 by ARCSA, defined “new chemical entity” in a complex manner. This definition generated inconsistencies with Andean Community Decision 486 and the Organic Code for the Social Economy of Knowledge, Creativity, and Innovation. These instruments are essential for protecting intellectual property rights in the pharmaceutical field and for fostering innovation.

New chemical entity. - It is the medicine, ingredient, or active principle for human use or consumption that has never been employed for any therapeutic indication worldwide. New uses or secondary uses, as well as innovations or changes in the following aspects, will not be considered as a new chemical entity: pharmaceutical forms, indications or secondary indications, new combinations of known chemical entities, formulations, dosage forms, routes of administration, modifications of any kind that do not affect the mechanism of action, marketing and packaging conditions, and in general, those that imply new presentations.

The Key Intervention of Meythaler & Zambrano Abogados

As a result of the proactive involvement and timely management by Meythaler & Zambrano Abogados, ARCSA submitted an inquiry to the Attorney General’s Office. This led to a binding pronouncement from that authority, which concluded that, for the definition of “New Chemical Entity” by ARCSA, the pertinent provisions of the Organic Code for the Social Economy of Knowledge, Creativity, and Innovation must be applied, ensuring proper alignment with the international instruments ratified by Ecuador on this matter. This intervention was decisive in aligning the regulation with both national and international standards.

Update of the New Chemical Entity Definition

As a result of this specialized legal advice, on February 10, 2025, ARCSA reformulated the definition in CHAPTER II of the Resolution, adopting the following wording:

New chemical entity. - It is the medicine, ingredient, or active principle for human use or consumption that has not been previously approved in Ecuador.

This new definition simplifies the interpretation of the term and allows for the recognition of the exclusivity period for test data for new medicines, effectively protecting the investment in innovation.

Benefits for the Pharmaceutical Sector

Protection of Innovation: The update guarantees that pharmaceutical companies have an exclusive period to leverage their test data, thereby incentivizing research and development.
Regulatory Alignment: It ensures compliance with international regulations and national legal instruments, strengthening Ecuador’s regulatory framework.
Promotion of Development: With the simplified definition, the process of registering new medicines is facilitated, boosting the growth of the pharmaceutical sector.

Commitment to Legal Excellence

Meythaler & Zambrano Abogados reaffirms its commitment to providing legal advice of excellence, driving the modernization of the regulatory framework, and fostering innovation in the pharmaceutical sector. Our efforts have been key to updating the regulation, protecting investment in research, and creating a favorable environment for technological and scientific advancement in the country.

The partial reform to the technical sanitary regulation constitutes a significant step forward for the pharmaceutical industry in Ecuador by aligning the regulation with international standards and promoting innovation in the development of new medicines.