Colombia, Chile, Peru, Argentina and Venezuela: the regulatory hurdles and opportunities for pharma

摘要

Colombia allows pharmaceuticals that have been submitted for regulatory review to reach the market faster than Chile, Peru, Argentina and Venezuela, a survey of the five Latin American countries has found.However, all five countries fare poorly in comparison with the time it takes to bring drugs to the market in the US. This is surprising, given that the product approval time ranges from just 90 days in Colombia to up to a year in Peru, compared with the 10 months within which the US Food and Drug Administration targets reviewing at least 90% of new drug applications for innovative medicines (not including priority review drugs). The time it takes to bring products to market in some of the five Latin American countries is likely to be largely a reflection of delays in terms of securing patents in these countries. It may also reflect delays in obtaining price approval and the fact that official approval targets are not always met. These observations are discussed in a report published by Scrip Insights, a sister publication of Scrip Regulatory Affairs.The report is entitled Emerging Pharmaceutical Markets in Latin America1 and is part of a series of six new pharmaceutical market reports, with the other five reports focusing on Colombia, Chile, Peru, Argentina and Venezuela individually.