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FDA proposing to harmonise standards for generic drug approval.

Scott Gottlieb, head of the FDA is advancing the idea of streamlining drug approvals via regulatory convergence to enable a single global approval for multiple markets.

Considering it, this idea has a lot of attractions - it would enable pharma companies who develop generics to secure access to markets beyond their local ones. FDA has submitted a proposal to ICH recommending the development of internationally harmonized guidelines on scientific and technical standards for generic drugs. ICH is the global venue for harmonization of standards for pharmaceutical products, including both new drugs and generic drugs. Although many existing ICH guidelines are applicable to generic drugs, historically ICH has focused on standards for new drugs. As a result, there are areas specific to generic drugs where harmonized guidance is lacking. We anticipate that ICH will review FDA’s proposal and that the ICH Assembly will be invited to endorse the proposal at its next meeting in November 2018.

By collaborating with regulatory authorities and the pharmaceutical industry under ICH, we can identify areas where there’s a common interest in harmonization. And we can develop guidelines that will help streamline generic drug development and the regulatory review process across multiple regulatory regions, even in those that may have different legal requirements.

In pursuit of our longer-term goal of global approval of generic drugs, FDA plans to consider the possibility of a common reference standard in generic drug development.

By easing the barriers to global entry for generic firms and increasing commercial opportunities, FDA can support the economic stability of generic markets and encourage continued investment in this sector.