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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Last week’s round-up, 16-20 March 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud   Brexit-related guidance for companies 20 March 2020 The EMA’s Brexit-related guidance for companies has been updated, with the publication of updated ‘EMA notice to stakeholders’ and ‘EMA practical guidance’. The two documents explain the intricate preparations companies need to make to prepare for the end of […]

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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, 02 – 06 March 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud   Coronavirus: Drug shortage fears as India limits exports – BBC News 06 March 2020 In the wake of the coronavirus epidemic, India has limited the export of certain medicines and active pharmaceutical ingredients (APIs). India is the world’s largest supplier of generic drugs and almost 70% […]

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AMPULES

Last week’s round-up, 24-28 February 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud   European Pharmacopoeia updates testing for particulate contamination in pharmaceutical preparations 28 February 2020 The European Pharmacopoeia Commission has updated testing for particulate contamination in pharmaceutical preparations. General chapter 2.9.19. Particulate contamination: sub-visible particles, has been revised in order to supplement the Pharmacopoeial Discussion Group harmonised text, […]

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Last week’s round-up, 17-21 February 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud   Everyone’s a Critic: FDA Under Fire for High Drug Approval Numbers 21 February 2020 The FDA has recently been criticized for the high number of novel drug approvals granted in 2019. A study carried out by Harvard Business School, the University of Texas at Dallas, and […]

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Albanian Flag

Last week’s round-up, 10-14 February 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud   NDMA in Metformin: FDA Finds Low Levels in Only 2 of 10 Tested Products 14 February 2020 The FDA has tested several Metformin drug product and active substance samples for the potentially carcinogenic impurity NDMA. Most of the metformin drug product samples did not show any […]

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Last week’s round-up, 03-07 February 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud The Essential List of Regulatory Authorities in Europe 07 February 2020 RAPS has published a useful list of websites of drug and medical device regulatory authorities in Europe. The list includes links to websites of national regulators found in the European Union and European Free Trade Association […]

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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, 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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