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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