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CHMP highlights: May 2022MEDICINES |COMMITTEES
CHMP highlights: May 2022
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CHMP highlights: May 2022MEDICINES |COMMITTEES
CHMP highlights: May 2022
EMA's human medicines committee (CHMP) recommended 9 new medicines for approval in the EU, including 3 medicines to treat rare genetic diseases at its May 2022 meeting
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ICMRA-WHO statement on COVID-19 vaccine confidenceICMRA |Regulatory
ICMRA-WHO statement on COVID-19 vaccine confidence
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ICMRA-WHO statement on COVID-19 vaccine confidenceICMRA |Regulatory
ICMRA-WHO statement on COVID-19 vaccine confidence
The International Coalition of Medicines Regulatory Authorities (ICMRA) and WHO issued a statement to support healthcare professionals to enhance public confidence in COVID-19 vaccines
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EMA’s Veterinary Committee elects new chairCommittee |Regulatory
EMA’s Veterinary Committee elects new chair
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EMA’s Veterinary Committee elects new chairCommittee |Regulatory
EMA’s Veterinary Committee elects new chair
EMA’s Committee for Veterinary Medicinal Products (CVMP) elected Gerrit Johan Schefferlie from the Dutch Medicines Evaluation Board as its chair for a three-year mandate
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Monthly safety update for COVID-19 vaccinesCOVID-19 |Vaccines
Monthly safety update for COVID-19 vaccines
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Monthly safety update for COVID-19 vaccinesCOVID-19 |Vaccines
Monthly safety update for COVID-19 vaccines
EMA has released its latest safety update report on all COVID-19 vaccines authorised in the EU. It provides an overview of the safety monitoring of these vaccines
Latest news
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List item20/05/2022 COVID-19
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 May 2022
Nine new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its May 2022 meeting. A recommendation for marketing authorisation was adopted for Cevenfacta (eptacog beta (activated))...
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List item20/05/2022
First therapy to treat two types of Niemann-Pick disease, a rare genetic metabolic disorder
EMA has recommended granting a marketing authorisation in the European Union (EU) for Xenpozyme (olipudase alfa), a therapy for the treatment of non-central nervous system (CNS) manifestations of Acid Sphingomyelinase Deficiency (ASMD), a rare and...
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List item20/05/2022
Synchron Research Service: suspension of medicines over flawed studies
EMA’s human medicines committee (CHMP) has recommended the suspension of the marketing authorisations of several generic medicines tested by Synchron Research Services, a contract research organisation (CRO) located in Ahmedabad, India. The...
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List item20/05/2022
First therapy to treat rare genetic nervous system disorder AADC deficiency
EMA has recommended granting a marketing authorisation in the European Union (EU) for Upstaza (eladocagene exuparvovec), a therapy for the treatment of adult and paediatric patients with severe aromatic L-amino acid decarboxylase (AADC) deficiency...
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List item20/05/2022
First treatment for children with Progeria or progeroid like syndromes (rare premature aging syndromes)
EMA has recommended granting a marketing authorisation in the European Union (EU) under exceptional circumstances for Zokinvy (lonafarnib), a treatment for patients with a genetically confirmed diagnosis of Hutchinson-Gilford Progeria Syndrome or...
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List item17/05/2022 COVID-19
International regulators and WHO: support healthcare professionals to enhance public confidence in COVID-19 vaccines
EMA has endorsed a statement for healthcare professionals jointly developed by the International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) . The statement is aimed to help healthcare professionals...
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