EMA adopts five product-specific bioequivalence guidelines / Guidelines / Home - GaBi Online

EMA adopts five product-specific bioequivalence guidelines

Home/Guidelines | Posted 11/08/2017 0 Post your comment

The European Medicines Agency (EMA) has adopted five product-specific guidance documents on the demonstration of bioequivalence. The guidelines were published on 10 July 2017 and will become effective from 1 January 2018.

Bioequivalence studies, consisting of single-dose pharmacokinetic evaluations, are required for the registration of generic drugs in order to demonstrate that they are bioequivalent to a reference medicine. In general, bioequivalence testing provides a useful comparison for different products containing the same active ingredient. Bioequivalence studies therefore play a key role in the development of new generics, as well as in post-marketing authorization variations, fixed-dose combinations, extension of indications and hybrid applications.

The guidelines cover an HIV antiretroviral therapy (elvitegravir) and combination therapies (elvitegravir/cobicistat/emtricitabine/tenofovir and emtricitabine/rilpivirine/tenofovir), an antidepressant (vortioxetine) and a chemotherapy treatment for non-small cell lung cancer (crizotinib).

The guidance documents are intended to help companies design study programmes that meet the expectations of European Union regulators. It is expected that following the requirements of these guidance documents will ensure that the data submitted in support of a marketing authorization application complies with the appropriate scientific, regulatory and legal requirements.

For each medicine, the documents provide guidance in the form of a table on:

biopharmaceutical classification system (BCS)
type of bioequivalence study design
analyte (parent drug or metabolite) to be evaluated
bioequivalence assessment.

The agency is also still reviewing comments from a draft guideline on anticoagulant drug dabigatran. The deadline for comments on the guideline was 31 March 2017.

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.

Source: EMA