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Coronavirus: EMA organises a second public meeting about the new COVID-19 vaccines

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).

Coronavirus: the EMA gives a first positive opinion for COVID-19 vaccine

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.

Risk Minimisation Activities (RMA): clarifications for authorisation holders on Circular No. 635

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.

Give your opinion on a genetically modified drug for the treatment of certain lung and skin cancers

The FPS Public Health and the FAMHP would like to invite you to take part in the public consultation on a clinical trial testing the genetically modified drug Nous-PEV (formed by the experimental drugs GAd-PEV and MVA-PEV) for the treatment of certain lung and skin cancers. The public consultation will run from 10 November 2020 to 10 December 2020.

Submission of dossiers during end-of-year period: final date is 15 December, except for COVID-19 dossiers

During the end-of-year period the FAMHP will be closed from Friday 25 December 2020 up to and including Sunday 3 January 2021. Deadlines have been set for the submission of different types of files.

Influenza vaccine: People aged 50 years and over can get the vaccine in pharmacies without prescription

Because of COVID-19, it is even more important to vaccinate at-risk groups, including older people, as widely as possible against seasonal flu. All people aged 50 years and older can get the flu vaccine in pharmacies without a prescription issued by the doctor (general practitioner).

Coronavirus: EMA starts first rolling reviews of COVID-19 vaccines

EMA’s human medicines committee (CHMP), in which the FAMHP takes part, has started the first ‘rolling reviews’ of COVID-19 vaccines. The review concerns the vaccine developed by AstraZeneca and the University of Oxford and the vaccine developed by BioNTech and Pfizer.

Coronavirus – a new validation procedure for serological tests

In April 2020, the Belgian Federal Agency for Medicines and Health Products (FAMHP) and Sciensano set up an extraordinary validation procedure for serological tests for SARS-CoV-2. The procedure turned out to be effective during the initial phase of the pandemic. The situation being experienced by the manufacturers and distributors of these tests and by the clinical laboratories carrying out the tests has now returned to normal. This is why a staged return to the conventional way of working is now being implemented.

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