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03/12/2021 COVID-19

ICMRA and WHO map out flexibilities used by regulators to respond to the COVID-19 pandemic

The International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) have reviewed some of the practices applied by regulatory authorities worldwide to respond to the challenges faced during the COVID-19...

03/12/2021 COVID-19

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 November - 2 December 2021

PRAC update on risk of myocarditis and pericarditis with mRNA vaccines EMA’s safety committee (PRAC) has assessed recent data on the known risk of myocarditis and pericarditis following vaccination with COVID-19 vaccines Comirnaty and Spikevax (...

02/12/2021 COVID-19

EMA starts rolling review of Valneva’s COVID-19 vaccine (VLA2001)

EMA’s human medicines committee (CHMP) has started a rolling review of VLA2001, a COVID-19 vaccine being developed by Valneva. The CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical data...

01/12/2021 COVID-19

Increase in manufacturing capacity for COVID-19 vaccine from AstraZeneca

EMA’s human medicines committee (CHMP) has approved a new site to manufacture Vaxzevria (previously COVID-19 Vaccine AstraZeneca) finished product. The site, operated by WuXi Biologics, is located in Leverkusen, Germany. In addition to this new...

25/11/2021 COVID-19

Comirnaty COVID-19 vaccine: EMA recommends approval for children aged 5 to 11

EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use in children aged 5 to 11. The vaccine, developed by BioNTech and Pfizer, is already approved for use in...

24/11/2021

A vision for use of real-world evidence in EU medicines regulation

Enabling the use of real-world evidence (RWE) and establishing its value for regulatory decision-making on the development, authorisation and supervision of medicines in Europe by 2025: this is the vision of European regulators as outlined in an...

COVID-19 pandemic

QUICK LINKS

PRAC highlights December 2021

PRAC highlights December 2021

ICMRA-WHO report on regulatory flexibilities

ICMRA-WHO report on regulatory flexibilities

New COVID-19 vaccine under evaluation by EMA

New COVID-19 vaccine under evaluation by EMA

Increased manufacturing capacity for Vaxzevria

Increased manufacturing capacity for Vaxzevria

Latest news

ICMRA and WHO map out flexibilities used by regulators to respond to the COVID-19 pandemic

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 November - 2 December 2021

EMA starts rolling review of Valneva’s COVID-19 vaccine (VLA2001)

Increase in manufacturing capacity for COVID-19 vaccine from AstraZeneca

Comirnaty COVID-19 vaccine: EMA recommends approval for children aged 5 to 11

A vision for use of real-world evidence in EU medicines regulation

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