During its May 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) reviewed a number of safety signals related to COVID-19 vaccines. The evaluation of safety signals is a routine part of pharmacovigilance and is essential to ensuring that regulatory authorities have a comprehensive knowledge of a medicine’s benefits and risks.
Close monitoring of medicine stocks proved particularly useful during the COVID-19 pandemic. The FAMHP managed to act proactively and find solutions in time. The monitoring was done manually, but is now automated using a new Stock Monitoring Tool.
PRAC April 2021 – Conclusions and additional review on Vaxzevria (AstraZeneca’s COVID-19 vaccine), and new investigations on COVID-19 Vaccine Janssen
During its April 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded on very rare cases of unusual blood clots with low blood platelets reported with Vaxzevria (formerly COVID-19 Vaccine AstraZeneca) and started reviewing a safety signal of capillary leak syndrome in patients vaccinated Vaxzevria. Furthermore, the PRAC is also investigating thromboembolic events reported following vaccination with COVID-19 Vaccine Janssen.
Pilot project on Clinical Trial Regulation (CTR): webinar on the new temporary procedure for submission of initial dossiers
From mid-February 2021, a reservation system with time slots will be used for the submission of initial dossiers for the Clinical Trial Regulation (CTR) pilot project. This procedure will be explained during a webinar on 4 February 2021 at 2 PM.
The European Medicines Agency (EMA) will organise a second public meeting on 8 January 2021 to inform European citizens about the assessment, approval and roll-out of new COVID-19 vaccines.
Coronavirus: European Commission gives conditional market authorisation for vaccine against COVID-19
The European Commission granted a conditional marketing authorisation for Comirnaty, the Pfizer/BioNTech vaccine. The Commission is following the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
The European Medicines Agency (EMA) issued a positive opinion for Comirnaty, the Pfizer/BioNTech vaccine, making it the first COVID-19 vaccine that could be authorised for marketing in the European Union. This opinion still has to be confirmed by the European Commission. Belgium purchased the vaccine and will use it immediately in its vaccination campaign.
Update on the guidance document to assist clinical trials sponsors as part of the pilot project of the FAMHP
Based on the evolution of the pilot project for the new Clinical Trial Regulation, the FAMHP made an update on the guidance document to assist clinical trials sponsors as part of the pilot project for clinical trials.
Circular No. 635 of 4 May 2018 details the approval procedure for risk minimisation activities (RMA). Certain paragraphs of this circular could be misinterpreted and specific situations were not considered. Therefore, the FAMHP would like to provide details on the RMA material included in the medicine package and on the addition / modification of RMA material for a medicine that is already available on the market.
The FAMHP Medication errors working group has received 112 notifications of proven or potential errors since 2016. Thanks to these notifications, corrective or preventive measures were put in place, in collaboration with the pharmaceutical industry. The Agency encourages healthcare professionals and patients to report any actual or potential medication error.