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, 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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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, 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, 07 – 11 October 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   ICH Reverts to Previous Version of Guideline on Residual Solvents 11 Oct 2019 The ICH has reverted to its previous version of the guideline on residual solvents. This change affects the Permissible Daily Exposure (PDE) for ethylene glycol. In October 2018, an error correction procedure was launched to […]

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Last week’s round-up, 23-27 September 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   EMA advises companies on steps to take to avoid nitrosamines in human medicines 27 Sep 2019 All EU marketing authorisation holders of medicinal products containing chemically synthesized APIs need to review their medicines for the possible presence of nitrosamines within the next six months. The EMA is sending a notice to […]

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

By Tessa Fiorini-Cohen and Marthese Mifsud   Stella Kyriakides has been named the new European Commissioner for Health 13 Sep 2019 Kyriakides will preside over the implementation of the EU Medical Devices Regulation and the In Vitro Diagnostics Regulation. Ursula von der Leyen has specifically requested that the new commissioner focuses on effective implementation of this new regulatory […]

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Last week’s round-up, 19-23 August 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   Administrative Law Overview | RAPS 23 Aug 2019  A comprehensive overview of the United States’ federal administrative processes as related to regulatory affairs has recently become available on RAPS. The publication explains the Federal Register, Code of Federal Regulations, and the Administrative Procedures Act through which stakeholders can […]

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