Last week’s round-up, 25-29 November 2019

By Stephanie Allampalli and Marthese Mifsud   EMA to Implement Ombudsman’s Recommendations on Avoiding Bias 29 November 2019 The EMA has announced that it will be following the recommendations of EU ombudsman Emily O’Reilly, following an inquiry regarding the perception of bias in MA assessments. The inquiry was carried out due to concerns that interactions […]

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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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Last week’s round-up, 16-21 September 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   Biotech in Europe: A Strong Foundation for Growth and Innovation 21 Sep 2019 What makes European biotech attractive, what financing does it need to fuel growth, and what should biotech leaders and investors do to succeed? These three questions are the focus of a recent review by McKinsey & Company. Their […]

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Facilitating early access whilst maintaining quality: Highlights from a recent joint EMA-FDA workshop

By Tessa Fiorini-Cohen   The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) both have schemes to fast-track and support development of medicines which address unmet medical needs. Their underlying aim is to help patients benefit from such therapies as soon as possible. However, due to time constraints and novel situations, […]

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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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Malta Medicines Authority stakeholder meeting on 28th September 2016

Malta Medicines Authority stakeholder meeting – 28 September 2016

The Malta Medicines Authority (MMA) held its annual stakeholder meeting on 28th September. Two of us from Real Generics – Michelle Gafà and Tessa Fiorini Cohen – attended. The meeting was addressed by Helena Dalli, Minister for Social Dialogue, Consumer Affairs and Civil Liberties and by Anthony Serracino Inglott, Chairperson of the MMA. Various presentations […]

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Elemental impurities

Real Generics’ Regulatory News Digest For Generics – 10 August 2015

Draft ICH Guidelines for Consultation Mutagenic impurities ICH has released a draft addendum to ICH Guideline M7 on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk. The addendum summarises known mutagenic impurities commonly found or used in drug synthesis (e.g. aniline, dimethyl sulfate, ethyl chloride, hydroxylamine), providing acceptable […]

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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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