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Mexico to Issue Regulations for Approval of "Biocomparable" Drugs

By Donald Zuhn, Kevin Noonan, Chris Singer, Sherri Oslick, and Jason Derry

By Juan Serrano -- The Mexican General Health Law was reformed on June 11, 2009 to include an article 222 bis, which defined biotechnological drugs, and allowed for the approval of "biocomparables." The decree came into force on September 8, 2009, and the Ministry of Health had a 180-day period to issue all specific regulations pertaining to the approval of these biocomparables. Even though the 180-day period expired on March 8, 2010, work on the project of regulations has continued, with input being provided by both the Mexican Association of Pharmaceutical Research (AMIIF) and the National Association of Drug Manufacturers...

Full post as published by Patent Docs on July 28, 2010 (boomark / email).