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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.

Medication errors: 112 errors reported to the FAMHP since 2016

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.

The federal government and the federated entities work together to vaccinate at least 8 million Belgians.

The Inter-ministerial Conference on Public Health andthe Government Commissioner for Corona give more details on the vaccination strategy.

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.

Flash VIG-news: ESMYA® (ulipristal acetate 5 mg): revocation of the marketing authorisation

After reviewing the benefit-risk ratio of the medicinal product ESMYA®, the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the definitive revocation of its marketing authorisation (MA).

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