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

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud Ph. Eur. launches a public consultation on a new general chapter for the analysis of N-nitrosamines 09 April 2020 The new Ph.Eur. general chapter on the analysis of N-nitrosamine impurities in active substances (2.4.36) published in the Pharmeuropa 32.2 is open for public consultation from April to […]

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work remotely

Last week’s round-up, 30 March – 03 April 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud   FDA Seeks Withdrawal of Heartburn Drugs Due to New Carcinogen Concerns 3 April 2020 The FDA has requested immediate withdrawal of all ranitidine products from the US market. The carcinogen N-Nitrosodimethylamine (NDMA) has now been found to increase significantly in ranitidine products stored at higher temperatures, […]

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Last week’s round-up, 23 – 27 March 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud   EU-China Working Group to Address API Manufacturing Concerns 27 March 2020 China’s National Medical Products Administration (NMPA) will be working with the European Commission’s DG Sante, the European Medicines Agency (EMA) and others to conduct a gap analysis between the Chinese and EU regulatory systems for […]

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COVID-19

Last week’s round-up, 09 – 13 March 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud   Advice For Management Of Clinical Trials In Relation To Coronavirus 13 March 2020 In view of the current Covid-19 pandemic, the MHRA Inspectorate has released advice with regards to the management of clinical trials. Due to restrictions to limit the spread of the coronavirus, patients with […]

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Last week’s round-up, 27-31 January 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud   Nitrosamine contamination: new web page on EDQM response 31 January 2020 The EDQM website now contains a web page providing centralised access to all information related to nitrosamine contamination. This resource page is regularly updated and contains general information as well as details on actions taken […]

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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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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, 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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keyboard and monitors

Last week’s round-up, 28 October 2019 – 01 November 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   OGD Explains How it Reviews and Conducts Pre-ANDA Meetings 01 November 2019 The FDA’s Office of Generic Drugs (OGD) has explained how it evaluates and conducts meetings under its pre-abbreviated new drug application (ANDA) program. To this end, the OGD has issued a manual of policies and procedures, […]

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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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