Chile's plans to create drug regulatory agency
The Chilean parliament will examine legislation for a national medicines agency, which is good news for global drugmakers, according to Pharma Times.
Health Minister Jaime Manalich said he is sending legislative proposals to parliament to create the Agencia Nacional de Medicamentos (Anamed), which will take over drug regulatory responsibilities from the National Institute of Public Health (ISPCH). One important responsibility of the new agency will be enforcement of bioequivalence requirements—which will monitor manufacturing of “me-too” drugs.
Anamed will be particularly positive for international drugmakers, "which have been involved in long judicial battles against local manufacturers of 'me-too' drugs without bioequivalence accreditation," note analysts at IHS Global Insight.
The lack of effective patent enforcement in Chile and failure to adequately implement data protection continue to be major issues for U.S. drugmakers, who recently requested the U.S. Trade Representative (USTR) that Chile should remain on the US Priority Watch List of intellectual property rights (IPR) transgressors. Chile does appear on the Priority Watch List in the USTR's newly-published 2011 Special 301 Report on IPR, which says that “the U.S. urges Chile to provide adequate protection against unfair commercial use, as well as unauthorized disclosure, of undisclosed test and other data generated to obtain marketing approvals for pharmaceutical products."
Other areas of responsibility for Anamed potentially include: oversight of GMP, with a goal of accrediting at least 50% of manufacturers operating in the country; establishing an average 152 days for the registration of new drug products and 125 days for similar products; improving pharmacovigilance; creating a framework for drug trials in humans; strengthening cooperation with other Latin American drug regulators such as Argentina's Anmat and Brazil's Anvisa; and developing international partnerships in both the public and private sectors.