The national regulatory authority for approval of medicines in Iran, the Iranian Food and Drug Organization (FDO), has issued its new guidelines for registration of biologicals (recombinant medicines and monoclonal antibodies) in Iran. The guideline which was published online on 15 March 2014 describes the requirements for registration of both imported and locally manufactured biopharmaceuticals into the Iranian pharmaceutical market.
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Generics
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Biosimilars
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