Last week’s round-up, 18-22 November 2019

By Stephanie Allampalli and Marthese Mifsud CHMP’s Position on NDMA in Ranitidine 21 November 2019 The CHMP has held discussions on the course of action to be taken within the EU over the presence of the carcinogenic impurity NDMA in some batches of ranitidine medicines. In order to assess the potential root causes and their […]

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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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Last week’s round-up, 23-27 September 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   EMA advises companies on steps to take to avoid nitrosamines in human medicines 27 Sep 2019 All EU marketing authorisation holders of medicinal products containing chemically synthesized APIs need to review their medicines for the possible presence of nitrosamines within the next six months. The EMA is sending a notice to […]

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