During its April 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) discussed a direct healthcare professional communication (DHPC) containing important information for Defitelio.
The European Commission has launched a call for tender to conclude single (consortium) framework contracts to reserve manufacturing capacities and obtain a priority right to manufacture vaccines in case of a future public health emergency. The project is called EU FAB.
The FAMHP and pharma.be are organising two half-day symposia on vaccines on 10 and 12 May 2022. The first day will focus on the FAMHP and the VACCINES spearhead. This will cover topics such as clinical trials, regulatory activities, pharmacovigilance, and inspections. The second day will focus on effective vaccination, before closely examining the way vaccination campaigns are organised and implemented, vaccine hesitancy, and data collection. You can register now.
The current war in Ukraine has had a huge impact on clinical trials in Ukraine, Russia and Belarus. Due to the war, a large number of patients in these countries participating in clinical trials are no longer able to participate. There are also problems with the supply of medicinal products and other supplies for conducting clinical trials. The relevant authorities in countries within the European Union are making every effort to ensure the continuity of treatment for patients in ongoing clinical trials by providing the option to continue their treatment at trial sites abroad.
During its April 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded that available evidence does not support a causal link between COVID-19 vaccines Comirnaty and Spikevax and very rare cases of autoimmune hepatitis.
The Head of Medicines Agencies has approved the extension of the European pilot project for simultaneous national scientific advice at its 107th meeting in February 2022. The approval followed a positive evaluation of the first results of the project since its launch in February 2020.
Since the start of the COVID-19 health crisis, the FAMHP has given the highest priority to requests for national scientific-technical advice (STA) on medicines against COVID-19. The National Innovation Office and Scientific-Technical Advice Unit uses accelerated timelines for requests regarding medicines that prevent or cure COVID-19 infections. These timelines are crucial to support accelerated clinical research on new medicines against COVID-19.
The European Medicines Agency's Safety Working Party clarifies its recommendations on genotoxic medicines and the duration of contraception to apply to any genotoxic active substance, regardless of its therapeutic indication. However, the recommendations should not apply to active substances whose mechanism of genotoxicity is known to have a threshold which is not expected to be reached in patients. Marketing authorisation holders should take these new clarifications into account when considering the need to update their package leaflets.