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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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, 30 September – 04 October 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   Delays in treatment of requests for revision and renewal of CEPs 03 Oct 2019 The EDQM has communicated that it is currently experiencing some difficulty in achieving the assessment times for revisions and renewals of CEP applications. The delay is currently about 5 weeks and the EDQM has […]

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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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Last week’s round-up, 09-13 September 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   Stella Kyriakides has been named the new European Commissioner for Health 13 Sep 2019 Kyriakides will preside over the implementation of the EU Medical Devices Regulation and the In Vitro Diagnostics Regulation. Ursula von der Leyen has specifically requested that the new commissioner focuses on effective implementation of this new regulatory […]

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Last week’s round-up, 02-06 September 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   Has AI Discovered a Drug Now? Guess. 06 Sep 2019 The media is abuzz with reports that an artificial intelligence model has designed a drug in 21 days, however an opinion piece in Science Translational Medicine takes a more nuanced view. The software model is acronymed GENTRL (generative tensorial reinforcement learning), […]

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« Le Penseur » vu sur son côté droit by Flickr user couscouschocolat

Last week’s round-up, 26-30 August 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   Particulate Contamination: sub-visible particles in non-injectable liquid preparations 30 Aug 2019 A new draft chapter on particulate contamination by sub-visible particles in non-injectable liquid preparations has been released by the EDQM, within Pharmeuropa 31.4. Two methods through which such particulate contamination can be detected are specified within it: a light obscuration […]

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Last week’s round-up, 19-23 August 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   Administrative Law Overview | RAPS 23 Aug 2019  A comprehensive overview of the United States’ federal administrative processes as related to regulatory affairs has recently become available on RAPS. The publication explains the Federal Register, Code of Federal Regulations, and the Administrative Procedures Act through which stakeholders can […]

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Last week’s round-up, 12-16 August 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   MHRA’s no-deal Brexit guidance 12 Aug 2019 Updates to the MHRA’s no-deal Brexit guidance have indicated a shift in the government’s willingness to leave without a deal. The guidances typically started with the following statement, which has now been dropped: “Leaving the EU with a deal remains the […]

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