Colombia becomes the most clinical trial-friendly country in Latin America; it now boasts the best study protocol approval times in the region: 30 days for medical devices and 60 days for drugs
Colombia's National Institute of Food and Drug Monitoring (INVIMA), announced that it has reduced from 4.5 months (135 days) to 2 months (60 days) the processing time for the evaluation and approval of a clinical research study protocol involving an investigational drug. INVIMA announced this change on its website on April 12, 2016, and stated that it would achieve this time reduction by improving the efficiency of internal processes without compromising the quality of the evaluation of a study protocol. INVIMA can also approve a medical device study protocol in 30 days. With this change, Colombia becomes the most competitive country in Latin America —and one of the top most competitive countries in the world— to attract innovative life science companies to conduct clinical research at Colombia's over 120 ICH-GCP clinical research centers.
In the past, INVIMA had an internal serial —and lengthy drug research protocol evaluation process that involved first evaluating the technical components of the study protocol, and then the quality of the investigational drug. With INVIMA's new process, now these two activities are performed in parallel. INVIMA also announced that now the Clinical Research Group —under its Drugs and Biological Products Department— will be in charge of the evaluation of human research protocols involving investigational drugs; as opposed to the Specialized Committee for Drug and Biological Products before.
INVIMA assured that this greater efficiency and agility to approve an experimental drug study protocol would allow Colombians to have access to new treatment therapies and diagnostic mechanisms, and at the same time, ensuring the safety of study participants. INVIMA stated that this change will positively impact the health of Colombians. Also, INVIMA mentioned that this improved and faster evaluation process will result in the strengthening and encouragement of Colombia's domestic clinical research sector.
On August 20, 2015, representatives from Interventional Concepts and Colombia's clinical research industry associations met with high-level officials from Colombia's Ministry of Commerce, Industry and Tourism (MinCIT) to discuss the state of the global and domestic clinical research industry and why Colombia needed to make changes in its regulatory approval process to become more internationally competitive. Colombia's clinical research industry associations include Association for the Advancement of Clinical Research in Colombia —AVANZAR, Colombian Association of Clinical Research Centers —ACIC, and Association of Research & Development Pharmaceutical Laboratories —AFIDRO. Following this meeting, Interventional Concepts, AVANZAR, ACIC and AFIDRO worked on a formal request to MinCIT to work with INVIMA to improve its human research protocol approval process to make it more predictable, agile and internationally competitive. The final letter to MinCIT is available here: https://goo.gl/cbH1re
INVIMA's recent announcement that has drastically shortened —from 4.5 months to 2 months— the processing time to evaluate and approve a human study protocol for an investigational drug is the result of a concerted effort by the Government of Colombia working together with the domestic clinical research industry associations. They all collaborated to make Colombia the most competitive country in Latin America —and one of the top most competitive countries in the world— to attract innovative life science companies to conduct clinical research at Colombia's over 120 ICH-GCP clinical research centers.
Colombia's vision by 2025 is to become one of the top three innovative countries in Latin America by promoting human capital for the knowledge economy, research, and development (R&D) and innovation; and by raising awareness of science, technology and innovation in the Colombian society. Colombia is uniquely positioned to become a clinical research powerhouse. The country boasts a 60-day national regulatory approval time for investigational drugs —and 30 days for medical devices, a population of about 50 million with universal access to healthcare, and significant cost savings —over 30% of what it will cost to run a clinical research trial in the US or Europe.
Source: INVIMA (https://www.invima.gov.co/invima-reduce-el-tiempo-de-evaluaci%C3%B3n-de-protocolos-de-investigaci%C3%B3n-a-dos-meses)