Uruguay advances towards a regulatory framework to enhance drugs control
23 mayo 2018

On May 10, Health Minister Jorge Basso and Industry Minister Carolina Cosse from Uruguay announced that they are working on the creation of a drug regulatory authority and a regulatory framework for quality control of imported drugs. These statements were made at the 39th Latin American Pharmaceutical Industry Forum held in Montevideo.

Latin American pharmaceutical companies asked national health authorities to develop quality control mechanisms for imported drugs so that they meet the same quality requirements as those produced in the country. In response to that complaint, the Minister of Industry stated that “we are working on a regulatory framework that, if approved, will confer authority to the Technological Laboratory of Uruguay (LATU) to assess whether the imported products comply with the same processes as the national ones and act as the guarantor of certification of the imported products”.

Health Minister Basso further said that the Uruguayan pharmaceutical industry, responsible for 90 % of the medicines used in the country, “needs to have an authority to avoid compulsory outsourcing to other regulatory agencies.” One month after the approval of the first biosimilar drug manufactured in Uruguay, the Latin American Association of Pharmaceutical Industries (ALIFAR) gave a strong support to the regional development of biosimilars and condemned “unfair practices by multinational laboratories that restrict competition and monopolize the market for high-cost products”.