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 […]

Read More
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 […]

Read More

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% […]

Read More

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 […]

Read More
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 […]

Read More

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 […]

Read More

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 […]

Read More

Last week’s round-up, 25-29 November 2019

By Stephanie Allampalli and Marthese Mifsud   EMA to Implement Ombudsman’s Recommendations on Avoiding Bias 29 November 2019 The EMA has announced that it will be following the recommendations of EU ombudsman Emily O’Reilly, following an inquiry regarding the perception of bias in MA assessments. The inquiry was carried out due to concerns that interactions […]

Read More

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 […]

Read More
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 […]

Read More