EMA

EMA establishes Cancer Medicines Forum with academia to optimise cancer treatments in clinical practice

EMA, in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC), has launched the Cancer Medicines Forum (CMF). Bringing together representatives from academic organisations and the European medicines regulatory network, the forum aims at advancing research into optimising cancer treatments and will contribute to foster high standards in cancer care in the European Union (EU).

PRIME enables earlier availability of life-changing medicines

EMA's PRIority Medicines (PRIME) scheme has had a positive impact on the authorisation of new medicines that address patients’ unmet medical needs. The time to marketing authorisation was reduced for medicines that benefitted from PRIME support, giving patients earlier access to transformative treatments that can make a real difference to their health.

EMA: Human medicines highlights of 2021

In 2021, EMA recommended 92 medicines for marketing authorisation. Of these, 53 had a new active substance which had never been authorised in the European Union (EU) before. This is a 35% increase compared to the 39 medicines with a new active substance that were authorised in 2020. The overview of key recommendations in 2021 includes figures on the authorisation of medicines and a selection of new treatments that represent significant progress in their therapeutic areas.

EMA starts evaluating use of COVID-19 vaccine Comirnaty in children aged 5 to 11

EMA has started evaluating an application to extend the use of BioNTech/Pfizer's COVID-19 vaccine, Comirnaty, to children aged 5 to 11.

Comirnaty is a vaccine for preventing COVID-19, currently authorised for use in people aged 12 and older. It contains a molecule called messenger RNA (mRNA) with instructions for producing a protein, known as the spike protein, which is naturally present in SARS-CoV-2, the virus that causes COVID-19.

First-in-class medicine to treat aggressive form of breast cancer

EMA has recommended granting a marketing authorisation in the European Union (EU) for Trodelvy (sacituzumab govitecan), a first-in-class medicine to treat adult patients with unresectable (cannot be removed by surgery) or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for advanced disease.

EMA evaluating data on booster dose of COVID-19 vaccine Spikevax

EMA has started evaluating an application for the use of a booster dose of Spikevax (Moderna’s COVID-19 vaccine) to be given at least 6 months after the second dose in people aged 12 years and older.

Booster doses are given to vaccinated people (i.e. people who have completed their primary vaccination) to restore protection after it has waned.

Call for expressions of interest for civil society representatives to participate in work of EMA

The European Commission has launched calls for expressions of interest to represent patient, healthcare professional and veterinarian organisations in EMA's Management Board and Pharmacovigilance Risk Assessment Committee (PRAC).

Representatives of civil societies play an important role in the Agency's work, forming members of its scientific committees, reviewing information on medicines produced by the Agency and responding to specific requests for assistance.

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