pills

Last week’s round-up, 14 – 18 October 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   Updated product-specific bioequivalence guidance 18 Oct 2019 The EMA has finalised product-specific bioequivalence guidance for seven drug substances. The substances affected are alectinib, apixaban, cabozantinib, colchicine, ezetimibe, gefitinib, and palbociclib. All guidances were adopted on 15 October 2019. Those for apixaban and gefitinib will become legally effective on […]

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The EPO

Real Generics’ Regulatory News Digest For Generics – 24 November 2015

Planned changes to intellectual property protection in Europe Towards the end of October 2015, the European Commission published a working document entitled A Single Market Strategy for Europe – Analysis and Evidence. The document suggests a number of changes in intellectual property protection that would have a positive and significant impact on manufacturers of existing […]

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Real Generics’ Regulatory News Digest For Generics – 16 July 2015

EMA has issued product-specific bioequivalence guidance for: Sirolimus 0.5 mg, 1 mg and 2 mg coated tablets and 1mg/ml oral solution Sorafenib 200mg film-coated tablets Sunitinib 12.5mg, 25mg, 37.5mg and 50mg hard capsules Tadalafil 2.5mg, 5mg, 10mg and 20mg film-coated tablets Telithromycin 400 mg film-coated tablets Voriconazole 50 mg and 200 mg tablets and 40 […]

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