ICH proposes harmonization of standards for generics

Home/Guidelines | Posted 15/02/2019 post-comment0 Post your comment

As part of its efforts on harmonizing guidelines around the world the International Conference for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has released a reflection paper on the scientific and technical standards for generics.

Harmonize V13F28

The reflection paper, which was endorsed by the ICH Assembly on 13 November 2018, was released on 6 February 2019. The reflection paper outlines recommendations to develop a series of ICH guidelines on standards for demonstrating equivalence, e.g. bioequivalence, for (1) non-complex dosage forms and (2) more complex dosage forms and products. To accomplish this work, the ICH proposes that a generic drug discussion group be established to assist in assessing the feasibility of harmonization of standards for generics and to prioritize work areas.

ICH Reflection Paper: Further Opportunities for Harmonization of Standards for Generic Drugs
Date: 13 November 2018

The ICH says that ‘at present, a lack of harmonized standards reduces the number of potential markets in which data and information submitted in support of a generic drug marketing application can be used by a developer to support marketing authorization in another jurisdiction’. This, according to the ICH, can lead to monopolies in individual markets.

Harmonization, says the ICH, would prevent this from happening, and ‘may increase the size of generics markets and thereby attract more competition from developers, lower costs by increasing the number of market entrants, and expand patient access in jurisdictions in which developers otherwise may have decided not to pursue marketing authorization’.

The release of this reflection paper comes after the US Food and Drug Administration asked the ICH in November 2018 to advance the harmonization of scientific and technical standards for generics [1].

Related article
Generics group calls for say on ICH standards

1. GaBI Online - Generics and Biosimilars Initiative. FDA proposes standardization of generics standards [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 15]. Available from: www.gabionline.net/Generics/General/FDA-proposes-standardization-of-generics-standards

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2019 Pro Pharma Communications International. All Rights Reserved.

Source: ICH

comment icon Comments (0)
Post your comment
Related content
FDA updates generics guidance due to COVID-19 pandemic
34 AA010660
Home/Guidelines Posted 01/10/2021
WHO guidelines on pharmaceutical pricing policies
Pay for Delay DrugsMoneyGeneric V13F21
Home/Guidelines Posted 24/09/2021
Mexico introduces new decree on health regulation
Home/Guidelines Posted 27/08/2021
Most viewed articles
About GaBI
Home/About GaBI Posted 05/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010