COFEPRIS Accepts Foreign Evaluations to Speed Up Clinical Trials

SSA introduced a regulatory measure aimed at streamlining the approval of clinical research protocols by recognizing evaluations conducted by select international agencies. COFEPRIS issued an agreement that implements Regulatory Reliance Practices, allowing the acknowledgment of foreign regulatory decisions that adhere to both international standards and national regulations governing health research.

This measure aligns with the guidelines set forth by the WHO and PAHO. Through this agreement, COFEPRIS will recognize assessments performed by at least one of the following regulatory agencies: the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom, and Health Canada.

The agreement is intended to accelerate the evaluation of clinical research protocols, facilitating quicker access to innovative medical therapies while ensuring compliance with Good Clinical Practice standards, states SSA. It also aims to enhance regulatory efficiency by reducing redundant efforts and strengthening trust in emerging therapies under investigation.

By fostering collaboration with globally recognized regulatory agencies, the measure is expected to bolster Mexico’s position as a hub for clinical research and pharmaceutical development.