Harmonization Needed For Complex And Value-Added Drugs
As ICH Works Towards Global Harmonization On Generics
Complex generics and value added medicines share common challenges on harmonization of regulation, lack of incentives and clarity of guidelines, heard delegates to Medicines for Europe’s Regulatory & Scientific Affairs conference.
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For the first time, a working group within the International Council for Harmonization has started work on a regulatory topic specifically tailored to the global generics and biosimilars industry.
Aset of “internationally harmonised guidelines on scientific and technical standards for generic drugs” should be developed through the International Council forHarmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), according to a proposal that has been put forward by the US Food and Drug Administration (FDA).
While the AAM is lobbying for a renewed focus on domestic drug production amid fresh concerns about the globalization of the US pharmaceutical drug supply chain, the association has urged US Congress to have confidence in FDA oversight, insisting that “the US has one of the safest drug supply chains in the world.”