Last week’s round-up, 13-17 January 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud   The Art of doing Clinical Regulatory well 17 January 2020 The landscape of clinical regulatory is becoming increasingly challenging to navigate, with over 8000 clinical trial applications in the EEA every year and increasingly diverse requirements to fulfil. These challenges have pushed clinical trial sponsors into […]

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Heartburn by Flickr user Christopher Dart

Last week’s round-up, 06-10 January 2020

By Tessa Fiorini-Cohen, Stephanie Allampalli and Marthese Mifsud   Decentralised Procedure – Requests to act as RMS 10 January 2020 National competent authority instructions for DCP RMS slot requests have been updated: http://bit.ly/RealGenerics-2NgpZTs   The Decade In Global Health: New Drugs, Faster Trials, Social Media To The Rescue 09 January 2020 When it comes to […]

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Round-up, 23 December 2019 – 03 January 2020

By Tessa Fiorini-Cohen, Stephanie Allampalli and Marthese Mifsud   European Paediatric Formulary online 03 January 2020 The EDQM has announced that the European Paediatric Formulary can now be accessed free of charge on a dedicated online platform. The project, launched by the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH) and the European Pharmacopoeia Commission, […]

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Round-up, week 16 – 20 December 2019

Round-up, week 16-20 December 2019 By Tessa Fiorini-Cohen, Stephanie Allampalli and Marthese Mifsud   Pharmtech series of articles on Pharmacopoeia Compliance 16 December 2019 Pharmtech has published a  series of articles on Pharmacopoeia Compliance. The articles include: Why Pharmacopoeia Compliance Is Necessary Why Pharmacopoeia Compliance Is Difficult A Brief History of Pharmacopoeias: A Global Perspective […]

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

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud Nitrosamine risk assessments for all substances for pharmaceutical use? 12 December 2019 The Ph. Eur. Commission has proposed an update to the monograph on Substances for Pharmaceutical Use, to introduce nitrosamine risk assessments for all substances (active substances and excipients), not only those obtained through chemical synthesis […]

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

By Stephanie Allampalli and Marthese Mifsud   Metformin is being evaluated for nitrosamine impurity content. 06 December 2019 The Singaporean Health Sciences Authority has recalled some metformin products due to unacceptable levels of NDMA. On 5th December, the US FDA issued a statement saying that it has started evaluating metformin products for nitrosamines. (See link […]

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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, 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, 11 -15 November 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   ICH Survey Shows Wide Adoption of Guidelines Among Regulators, Industry 15 November 2019 A recent survey shows wide adoption of ICH guidelines across regulators and industry. The survey collected responses from 32 pharmaceutical companies who provided information on 15 regulatory authorities, which ranged between ICH founding members, newcomers […]

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BREXIT

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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