Mexico's health regulatory agency Cofepris is implementing new digital tools to reduce clinical trial approval times to 30 days [1].
These changes aim to reduce bureaucracy and attract international investment to strengthen the national health industry. By speeding up the regulatory pipeline, the agency intends to make Mexico a more competitive hub for medical research and pharmaceutical development [3].
The agency is targeting a reduction in approval times from the current 45 days down to 30 days [1]. This acceleration is part of a broader effort to digitize the sanitary registration process, which has historically been a bottleneck for pharmaceutical companies entering the Mexican market [1].
As part of this digital shift, Cofepris introduced the Visor de Registros Sanitarios [2]. This tool allows users to verify the legality of medications in seconds, providing a transparent window into the status of sanitary registrations [2]. The tool is designed to simplify the process for both regulators and the public, ensuring that approved medicines are easily identifiable [4].
These regulatory shifts are already influencing private sector strategy. Bayer has announced plans to triple the number of clinical studies and related investments within Mexico [3]. The company's decision follows the agency's commitment to streamlining the path from research to market approval [3].
Cofepris said these measures are designed to foster an environment where innovation can happen more quickly. The agency intends to continue expanding its digital infrastructure to further prune administrative delays [1].
“Cofepris aims to reduce clinical trial approval time from 45 days to 30 days.”
The transition toward a 30-day approval window and the launch of digital verification tools signal Mexico's intent to integrate more deeply into the global pharmaceutical supply chain. By lowering the administrative barrier to entry, the country is positioning itself as a more attractive destination for multinational clinical trials, which can lead to increased high-tech employment and faster patient access to experimental therapies.
