Tag: EMA

Good AI Practice: EMA and FDA Establish 10 Global Principles

Global regulators are setting a unified standard for the digital transformation of the pharmaceutical industry. The European Medicines Agency...

Kinder recalls chocolate eggs after salmonella cases

Italian confectionery group Ferrero said on Tuesday it is recalling Kinder chocolate eggs in several European countries because of...

EU recommendations for seasonal influenza vaccine composition

Every year, EMA's ad hoc Influenza Working Group issues EU recommendations for the composition of seasonal influenza vaccines on...

EMA agency starts review of Spain’s Hipra Covid-19 vaccine

EMA’s human medicines committee (CHMP) has started a rolling review of the vaccine against Covid-19 of the biotechnological pharmaceutical...

Pharmacovigilance risk assessment committee: Spikevax and Comirnaty mRNA vaccines

European Medicines Agency has published Meeting highlights from the Pharmacovigilance Risk Assessment Committee  (PRAC) 7-10 March 2022. COVID-19 Vaccine Janssen:...

EMA – New medicine for rare type of eye cancer

EMA has recommended granting a marketing authorisation in the European Union (EU) for Kimmtrak (tebentafusp), a monotherapy for the...

EU regulator approves Pfizer-BioNTech vaccine booster for ages 12 to 17

Pfizer Inc. and BioNTech announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines...

EMA recommends approval of Spikevax for children aged 6 to 11

EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Spikevax to include...

EU adopts a common standard for the electronic product information on medicines

The European Medicines Regulatory Network has adopted a Common Standard for the electronic product information (ePI) on medicines in...

The European Medicines Agency has published key information on human and veterinary medicines for 2021

The overview of key recommendations in 2021 includes figures on the authorisation of medicines and a selection of new...

Pfizer Covid Pill Europe’s First Approved Oral Treatment Against Covid

Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued...

The European Medicines Agency (EMA) proposes European Union (EU) clinical trial reforms

The European Commission (EC), European Medicines Agency (EMA) and EU regulators from The Heads of Medicines Agencies have set...