Australia to adopt EMA generics guidelines

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The Therapeutic Goods Administration (TGA), Australia’s regulatory body for therapeutic goods, announced on 10 April 2015 that it was carrying out public consultations on the adoption of European Union (EU) guidelines in Australia.

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The documents under question include guidelines on clinical pharmacology and pharmacokinetics, blood products and biological guidelines, and also include the European Medicines Agency’s (EMA) new concept paper on product-specific guidance for bioequivalence for generics.

EMA’s concept paper on product-specific bioequivalence was published for public consultation on 1 August 2013 and the consultation ended on 30 September 2013.

Concept paper on the development of product-specific guidance on demonstration of bioequivalence
EMA/CHMP/423137/2013
Date: 1 August 2013
End of consultation: 9 November 2016
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/07/WC500147001.pdf 

The concept paper outlines EMA’s plans to produce product-specific guidelines for generics. The agency also outlines the items that should be addressed in the product-specific guidance. These include:

• Classification according to the Biopharmaceutical Classification Scheme (BCS) if a BCS biowaiver seems possible.
• Design elements of a bioequivalence study, i.e. administration schedule, study participants, conditions for administration (fasting/fed), strength to be investigated, and number of studies.
• Analyte for the bioequivalence demonstration, i.e. parent/metabolite, compartment (plasma/blood/urine), and need for an enantioselective method.
• Criteria for bioequivalence assessment, i.e. main pharmacokinetic variables and width of confidence intervals.

The EMA first published product-specific guidelines in November 2013 [1]. Since then, the agency has finalized 26 product-specific guidelines and, as of 29 September 2016, had 10 further guidelines under public consultation.

TGA is asking for comments on the proposed adoption or non-adoption of the EU guidelines, and in particular as to whether stakeholders support the proposed adoption of the guidelines.

Feedback on the guidelines can be submitted to TGA until 9 November 2016 via post or email (euguidelines@tga.gov.au).

Related article
Australia to adopt EMA’s biosimilars guidelines

Reference
1. GaBI Online - Generics and Biosimilars Initiative. EMA releases product-specific bioequivalence guidelines [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 7]. Available from: www.gabionline.net/Guidelines/EMA-releases-product-specific-bioequivalence-guidelines

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Source: EMA, TGA

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