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FDA Looks to Harmonize Generic Drug Scientific and Technical Standards via ICH

Posted 18 October 2018 | By Zachary Brennan 

FDA Looks to Harmonize Generic Drug Scientific and Technical Standards via ICH

The US Food and Drug Administration (FDA) revealed Thursday that it’s offering a proposal to the International Council on Harmonisation (ICH) to better harmonize scientific and technical standards for generic drugs.

The plan is to allow generic drug developers to implement a single global drug development program, with common elements of applications to file, to allow for simultaneous approvals in multiple markets.

“This would make it easier for developers that would otherwise only seek generic drug approval in one region to also seek approval in the United States, increasing competition in America. And it would also make it easier for developers that would otherwise only seek generic drug approval in the US market to gain access to other markets,” FDA Commissioner Scott Gottlieb said in a statement.

More specifically, FDA is 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. FDA expects that ICH will review FDA’s proposal and that the ICH Assembly will endorse the proposal at its next meeting in November 2018.

As far as areas for potential consideration, Theresa Mullin, associate director for strategic initiatives at FDA, told attendees of the Association for Accessible Medicines (AAM) conference in September, of the possibilities:
  • A series of ICH guidelines on bioequivalence standards for simple and complex dosage forms;
  • A survey of existing ICH guidelines for updating as needed to incorporate recommendations for generic drugs.
“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,” Gottlieb added.

Manufacturing specifications may also differ between countries.

“For example, right now a specific drug may need to be tested under different dissolution methods and acceptance criteria to satisfy both the FDA and the European Medicines Agency’s (EMA) regulatory requirements,” Gottlieb said, noting that the lack of harmonization across basic components of generic drug development reduces the opportunities for generic drug developers to use their data and information across multiple applications in different jurisdictions.

AAM said in a statement that it supports FDA in this initiative and looks forward to working closely with them on it.


FDA also recently conducted a preliminary analysis that found there are significant opportunities to expand the availability and increase market competition for generic drugs beyond their current markets.

In particular, FDA explored the question of whether there appear to be opportunities for countries to gain access to generic drugs not currently available. In addition to the US market, FDA used data available from 2017 for a sampling of nine other countries including five in the EU (France, Germany, Greece, Poland and the UK), Japan, Canada, Switzerland and Australia.

“First, FDA looked at whether the top 100 drugs dispensed in the U.S. were also available in those nine other countries and found that all of the nine experienced some lack of availability of these drugs, which ranged from 5 (of 100) unavailable in Canada to 25 (of 100) unavailable in Japan,” Gottlieb said.
“Next, FDA examined the set of approximately 400 generic drugs with the lowest volumes sold in the U.S. used as a proxy for lowest level of U.S. availability. FDA found that only 35 percent of these drugs were available in the other nine countries and 65 percent of these drugs appear to be unavailable,” he added.


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