Last week’s round-up, 21 – 25 October 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   EMA to Cease Printing and Dispatching of CPPs During Relocation to Permanent Building 25 Oct 2019 The EMA will temporarily cease printing and dispatching of Certificates of Pharmaceutical Products (CPPs) during relocation to its permanent building. This temporary suspension will take place between 13th December 2019 and 18th […]

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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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Last week’s round-up, 07 – 11 October 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   ICH Reverts to Previous Version of Guideline on Residual Solvents 11 Oct 2019 The ICH has reverted to its previous version of the guideline on residual solvents. This change affects the Permissible Daily Exposure (PDE) for ethylene glycol. In October 2018, an error correction procedure was launched to […]

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Deconstructing the revised EMA guideline on manufacture of the finished dosage form

Source: Regulatory Rapporteur – Vol 14, No 9, September 2018 Authors: Tessa Fiorini Cohen, Claire Corinne Azzopardi, Michelle Gafa Our recently published Regulatory Rapporteur article, deconstructs the text of the final guideline (EMA/CHMP/QWP/245074/2015) comparing it to the outdated 1996 guideline and the 2015 draft version along with summarising the main differences and reviewing stakeholder comments […]

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