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Rapporteur article, deconstructs the text of the final guideline (EMA/CHMP/QWP/245074/2015) comparing it to the outdated 1996 guideline and the 2015 draft version along with summarising the main differences and reviewing stakeholder comments […]

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