Mexico to Issue Regulations for Approval of “Biocomparable” Drugs
BY JUAN LUIS 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[...]
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