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EMA

The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).

Expert Articles

EMA recommends approval of Spikevax for children aged 6 to 11

Techno -
EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Spikevax to include use in children aged 6...
Regulatory News

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

Techno -
The European Medicines Regulatory Network has adopted a Common Standard for the electronic product information (ePI) on medicines in the European Union (EU). The EU...
World Pharma News

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

Techno -
The overview of key recommendations in 2021 includes figures on the authorisation of medicines and a selection of new treatments, as well as  safety...
Regulatory News

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

Techno -
Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending the...
World Pharma News

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

Techno -
The European Commission (EC), European Medicines Agency (EMA) and EU regulators from The Heads of Medicines Agencies have set out proposals in a new...
World Pharma News

European Medicines Agency receives application for conditional marketing authorisation for Paxlovid

Techno -
EMA has started evaluating an application for a conditional marketing authorisation for the oral antiviral medicine Paxlovid (PF-07321332 and ritonavir). The applicant is Pfizer...
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