COFEPRIS Shortens Pre-Approval Time For Clinical Trials


BMI View: Mexico's large and increasingly ageing population, high percent age 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 e n forcement 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)

As multinational pharmaceutical companies continue to outsource the research and development (R&D) to developing countries, there were more clinical trials conducted in developing countries. Mexico has recently improved its regulatory environment, reflected by the presence of foreign clinical research organisations (CROs) in Mexico increasing substantially. The international CROs Chiltern, Kendle, and Parexel have all expanded activity, following rivals such as Quintiles. US-based Parexel, which is already present in Brazil, Argentina, Peru and Chile, has pledged to 'formalise' its presence in Mexico, opening a consulting and clinical research office in Mexico City.

After COFEPRIS was recognised by the Pan-American Health Organization (PAHO) and the World Health Organization (WHO) as a National Regulatory Authority of Regional Reference of Medicines and Biological Products in July 2012, it also reduced the issue period for innovative drug approval from 360 days to 60 days if medicines are already approved in Europe, Canada, US and Switzerland. Confidence among Latin American countries (notably Chile, Peru, Colombia, El Salvador, Ecuador and Costa Rica) has been fostered to allow medicines approved by COFEPRIS to enter their domestic markets with a simplified process.

Mexico's improving regulation regime has encouraged multinationals to launch more innovative drug in the country and shorten the relative drug approval lags between Mexico and developed states. However, Mexico's progress has been hindered by institutional shortcomings, and regulatory agencies have been criticised for their weak enforcement of regulations. As the public institutions remain underfunded and there is a lack of well trained and experienced staff, clinical trial permits in Mexico have reportedly taken up to nine months to arrive, as opposed to three months in most of Western Europe, which has hindered foreign participation in this area. We believe that the new policy designed to tackle these issues will improve Mexico's clinical trial regulation regime, if reinforced properly.

This article is tagged to:
Sector: Pharmaceuticals & Healthcare
Geography: Mexico

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