Messy Rules For Non‐Biological Complex Drugs Under Fire
Executive SummaryCalls are mounting for the EU to make the centralized procedure mandatory for follow-on versions of non‐biological complex drugs and for better regulatory alignment with the US and other countries.
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Plans to streamline the approval of generic medicines in Australia must include measures to ensure that safe and effective similar versions of non-biological complex medicines are available.
Australian Generics Approval Reform Is Opportunity For International Work-Sharing On Non-Biological Complex Drugs
Three companies are set to learn this week whether the European Medicines Agency will fast track its review of their soon-to-be-filed EU marketing applications.