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News Article

COFEPRIS Goes Digital

By Miriam Bello | Mon, 01/10/2022 - 11:09

Mexican regulatory agency COFEPRIS created the Procedure Digitalization Platform DIGIPRiS to help users carry out procedures related to personal consumption. A digital platform has been a long-time wish for the industry.

COFEPRIS had been trying to digitize some processes even before President Andrés Manuel López Obrador’s administration. Digitalization would be incredibly beneficial for the industry as it would greatly reduce approval times, said Josué Garza, Director of Business Development and Operations, Insumos para la Salud. “COFEPRIS had a digital platform that advertising third party reviewers could use to submit their advertising permit application. However, the current administration put pause to this effort.”

The digitalization of COFEPRIS “will make processes more efficient,” told MBN Américo García, Director General of Mexico and Latin America, Apotex. This change is being accompanied by the acceptance of documentation in English, which “is positive for foreign companies like Apotex because it saves time and money spent on translation,” said García.

In addition to those services, DIGIPRiS will overview the paperwork, allow users to monitor the progress of the procedure or service they request from admission to conclusion and integrate electronic files and databases. The online platform will also maintain a historical base for statistical purposes, which will help COFEPRIS meet and advance its mission to ensure the safety and effectiveness of products that are used by the Mexican population.

Foreign regulatory agencies, such as the EU’s EMA, are also actively using tech to improve processes. Currently, EMA uses AI to improve text analytics, process documents and analyze text and images. EMA also applies Natural Language Processing methodologies to extract content from documents, structure its information, extract entities, categorizes and clustering content to be analyzed afterwards.

The FDA is also an active user of tech. In 2020 the agency released its Technology Modernization Action Plan (TMAP), which has three components: modernization of the FDA’s technical infrastructure and operations; enhancement of the FDA’s capabilities to develop technology products; and communication and collaboration with external stakeholders to drive technological progress that is interoperable and delivers value to consumers and patients.

Miriam Bello Miriam Bello Journalist and Industry Analyst