Advancing Toward the Goal of Global Approval for Generic Drugs: FDA Proposes Critical First Steps to Harmonize the Global Scientific and Technical Standards for Generic Drugs.
Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug. In other words, their pharmacological effects are exactly the same as those of their brand-name counterparts.
Generic drugs play a major role in treating illnesses all over the world and many rely on those to treat themselves in better cost level. But the approval of these drugs are not so rosy. So FDA is proposing a better global solution for the problem.
FDA’s Proposal to Harmonize Standards for Generic Drugs
To advance all of these goals, FDA has submitted a proposal to International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (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 particular, to fill these gaps, we’re proposing that ICH develop a series of guidelines on standards for demonstrating equivalence (e.g., bioequivalence) for both non-complex dosage forms, and for more complex dosage forms and drug products. These activities include pursuing opportunities like a harmonized bioequivalence study design that could be expanded to include additional study arms to accommodate more than one reference product for bridging purposes.
We’re committed to pursuing other ways to harmonize international standards for generic drugs while advancing FDA’s gold standard for rigorous, science-based regulation. This initiative is intended to lower barriers to global generic entry and could expand opportunities for U.S. generic drug developers. We want to improve the economic framework for generic drug development and manufacturing. And we want to promote generic drug competition.
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. And we can promote more product competition for American consumers.
Access to drugs is a matter of public health. We believe that harmonizing scientific and technical standards for generic drugs will help us advance a robust generic drug market that drives product competition, lowers drug prices, and increases patient access to high-quality drugs worldwide. Our work on harmonization is not limited to these proposals or generic drugs and our efforts across the agency have propelled medical advancements and led to increased product competition. We will continue to work with our international regulatory partners to advance policies that will help us continue to accelerate innovator and generic product development in order decrease barriers to increased drug competition.
Read the complete article by Scott Gottlieb, M.D., is Commissioner of the U.S. Food and Drug Administration
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