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FDA Developing ICH Reflection Paper on Generic Drugs

Posted 05 September 2018 | By Zachary Brennan 

FDA Developing ICH Reflection Paper on Generic Drugs

An informal working group at the US Food and Drug Administration (FDA) is developing a reflection paper outlining an approach for developing and enhancing ICH guidelines to support the harmonization of scientific and technical standards for generic drugs, Theresa Mullin, associate director for strategic initiatives at FDA, told attendees of the Association for Accessible Medicines conference on Wednesday.

The proposed work, according to Mullin, would target scientific and technical standards of generic drugs and would not be an attempt to harmonize differing regional legal or regulatory requirements.

As far as areas for potential consideration, Mullin noted three possibilities:
  • A series of ICH guidelines on bioequivalence standards for simple dosage forms;
  • A series of ICH guidelines on bioequivalence standards for complex dosage forms;
  • A survey of existing ICH guidelines for updating as needed to incorporate recommendations for generic drugs.
Mullin explained how harmonizing the scientific and technical standards for generic drugs could improve public health, particularly as it may allow manufacturers to use data submitted in support of a generic drug application to meet other regions’ regulatory requirements for approval.

She also highlighted how such harmonization could increase the size of markets, attract more competition and lower costs and expand patient access to generic drugs.

The use of reflection papers is part of shift at ICH, according to Mullin, in trying to be more strategic on how to pick new topics, and part of a shift from mostly individual one-off topics to putting forward discussion papers on revisions or enhancements of guidelines.

In addition to the reflection paper that's in the works, Mullin also noted three guidelines working their way through ICH’s five-step process that are of interest to the generic drug industry: M9, M10 and Q12.

Categories: Regulatory News

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