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Clinical Trial Evaluation Revolution: COFEPRIS Introduces New Transparent Model in Mexico

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The Federal Commission for Protection against Health Risks (COFEPRIS) marked a significant advancement in healthcare regulation with the announcement on May 14, 2024, of a groundbreaking new model for evaluating clinical trials. This innovative model is meticulously designed to optimize and bring unprecedented transparency to the clinical trial evaluation process, setting a new benchmark in healthcare standards. The initiative is a crucial development in the field of medical research in Mexico, as it aims to enhance the efficiency and clarity with which clinical trials are assessed.

This transformative approach by COFEPRIS not only aims to streamline the assessment procedures but also ensures that these evaluations align with international standards of practice. By introducing this model, COFEPRIS is looking to significantly bolster clinical research activities within the country. The model is expected to have a profound impact on the management and evaluation of clinical inputs across Mexico, potentially leading to faster and more efficient development of new medical treatments and innovations.

Moreover, the initiative reflects a strategic move towards enhancing the national infrastructure for clinical trials, which is fundamental for fostering an environment that supports medical research and development. With this new model, COFEPRIS is committed to improving how clinical studies are conducted, making it easier for researchers to navigate the regulatory landscape. This is crucial for ensuring that new medical products and therapies are brought to the market swiftly and safely, benefiting the public health sector at large.

COFEPRIS’ New Evaluation Model Positions Mexico as a Leader in Clinical Trial

In sum, the new evaluation model introduced by COFEPRIS represents a significant step forward in making Mexico a leader in clinical research and development. It is designed to ensure that all clinical trials conducted within the nation meet rigorous safety and efficacy standards, thereby enhancing the overall quality of healthcare services and products available to the Mexican population.

COFEPRIS’s latest initiative involves a comprehensive model that fully acknowledges the evaluation criteria and results authorized by ethics, research, and biosafety committees presented by applicants. This model aligns closely with international best practices for clinical research as established by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), of which Mexico has been a member since November 2021.

One of the key features of this new model is the optimization of import procedures for health inputs needed for clinical research conducted within the national territory, thus speeding up the response times to meet legal deadlines. Additionally, the evaluation process will be free from interruptions caused by administrative issues such as insurance validity, typographical errors, or form-filling errors, which do not fundamentally impact the research protocol evaluation.

Clinical Trial

COFEPRIS Launches Digipris Platform to Enhance Transparency and Efficiency in Clinical Trials

To foster complete transparency in health regulation, COFEPRIS will make the evaluation criteria publicly available for applicant review. This measure promises to transform the historical dynamics between regulated entities and the regulatory institution, offering a clearer, more direct pathway for submitting new protocols or changes to already authorized ones through the new Digital Platform for Research and Clinical Trials (Digipris).

The implementation of Digipris is strategic for attracting investments in research and the medical industry, significantly enhancing the clinical trial landscape in Mexico. By making the evaluation process more accessible and efficient, COFEPRIS aims to ensure that health products developed and tested in Mexico are effective, safe, and suitable for diagnosing, treating, and preventing diseases.

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COFEPRIS extends an invitation to specialists from both public and private sectors engaged in human clinical research to utilize Digipris for submitting new protocols or amendments to existing ones. This digital platform is expected to streamline the administrative processes associated with clinical trials, reducing delays and improving the management of clinical research projects. With these steps, COFEPRIS is setting a new standard for the regulation and support of clinical trials in Mexico. The health authority is committed to enhancing the infrastructure for clinical research, thereby ensuring that all health products are thoroughly evaluated and meet the highest safety standards before they reach consumers.


Resource: Gobierno De Mexico, May 14, 2024

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