S-cubed’s Regulatory Affairs team compiles the latest updates from the European Medicines Agency to the COVID-19 pandemic.
The European Medicines Agency (EMA) continues to update guidance and procedures in response to the COVID-19 pandemic, including measures being put in place to ensure that its activities related to the COVID-19 pandemic can continue during the Agency’s closure for Easter. The updates can be found by following the link here.
EU Executive Steering Group on Shortages of Medicines Caused by Major Events
EMA notes that the EU Executive Steering Group on Shortages of Medicines Caused by Major Events is currently setting up, in conjunction with the pharmaceutical industry, the industry single point of contact system (i-SPOC) to fast-track interaction on shortages between industry and the EU Executive Steering Group. Pharmaceutical companies will, for both centrally authorised and nationally authorised medicines, report any anticipated shortages or current shortages of critical medicines used in the context of COVID-19, directly to EMA. Companies will be expected to report any shortages to national agencies in the usual way.
EU authorities agree new measures to support availability of medicines used in the COVID-19 pandemic
Support for Potential Vaccines and Treatments
EMA is also supporting developers of potential vaccines or treatments for novel coronavirus infection, by encouraging them to contact EMA directly for discussions. In addition, EMA/CHMP Scientific Advice is being offered free of charge, and the advice procedures can be fast-tracked for potential novel coronavirus treatments or vaccines.
Decision of the Executive Director On fee reductions for scientific advice requests on products for the prevention and/or treatment of COVID-19
Impact on Clinical Trials and Clinical Trial Participants
The EU Regulatory Agencies also acknowledge the impact on clinical trials and clinical trial participants as a consequence of the extraordinary circumstances of the pandemic. In response, “Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic” has been published, with the stated aim of “ensuring the utmost safety of trial participants across the EU while preserving data quality.”
National Legislation and Guidance for Clinical Trials
Specific national legislation and guidance for clinical trials is also in place, and the dedicated pages for these on each National Regulatory Agency website can be accessed via the CTFG website.
Additional information, including advice on safety of medicines in COVID-19 patients and compassionate use programs can be found on the EMA’s dedicated Coronavirus disease (COVID-19) webpage.
Our team are ready to support and advise any companies working on COVID-19 at this unprecedented time. You can contact us via the usual channels: firstname.lastname@example.org, +44 1235 77 22 60 or the contact page.