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, 20-24 January 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud   EMA Consults on GMP Reflection Paper 24 January 2020 The EMA has just released a draft reflection paper on good manufacturing practice (GMP) and marketing authorisation holders (MAHs), which is open for public consultation until 17th April 2020. The paper focusses on clarifying the GMP responsibilities […]

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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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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Rapporteur article, deconstructs the text of the final guideline (EMA/CHMP/QWP/245074/2015) comparing it to the outdated 1996 guideline and the 2015 draft version along with summarising the main differences and reviewing stakeholder comments […]

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