COFEPRIS Shortens Pre-Approval Time For Clinical Trials
BMI View: Mexico's large and increasingly ageing population, high percentage of drug-naïve patients and improved regulatory environment, as well as the low cost in clinical research, has made it an attractive location for clinical trial outsourcing. However, growth of clinical trial sector has been hindered by institutional shortcomings, such as weak enforcement of regulations and a lack of well trained and experienced staff in the regulatory agencies. The new policy designed to tackle these issues will improve Mexico's clinical trial regulation regime, and provide more investment opportunities for multinationals.
Mexico's Federal National Commission for Protection against Health Risks (Comisión Federal para laProtección contra Riesgos Sanitarios, COFEPRIS) has changed its clinical research protocol to reduce the pre-approval time for clinical trials from three months to one month. COFEPRIS has also authorised the National Institutes of Health, as well as speciality hospitals, to assist its clinical trial evaluation process. Mikel Arriola, head of COFEPRIS, said that it will improve Mexico's global competitiveness in the pharmaceutical research and development (R&D) sector. 'We want pharmaceutical companies to do more research in Mexico on Mexican patients to provide better treatments,' Arriola stated 'Big pharma should increase R&D investment in Mexico to leverage the high quality local research institutions.'
Mexico's large and increasingly ageing population, high percentage of drug-naïve patients and improved regulatory environment, as well as the low cost in clinical research, has made it an attractive location for clinical trial outsourcing. As such, more clinical trials are taking place in Mexico. According to ClinicalTrials.gov, a service of the US National Institutes of Health, the number of clinical trials being conducted in Mexico has increased from 2 in 2001 to 196 in 2012, and most of the studies conducted in the country were phase III clinical trials to test the large-scale safety and efficacy of new molecules in drug development. In the Latin America region, behind Brazil (288), Mexico was the region's second largest clinical trial centre.
|Clinical Trials Increased|
|Mexico Clinical Trial Studies (2009-2012)|