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CHMP highlights: February 2021MEDICINES |COMMITTEES
CHMP highlights: February 2021
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CHMP highlights: February 2021MEDICINES |COMMITTEES
CHMP highlights: February 2021
EMA’s human medicines committee (CHMP) recommended six medicines for approval at its 22-25 February 2021 meeting.
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EMA issues guidance to address coronavirus variantsCOVID-19 |Vaccines
EMA issues guidance to address coronavirus variants
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EMA issues guidance to address coronavirus variantsCOVID-19 |Vaccines
EMA issues guidance to address coronavirus variants
EMA has issued guidance for vaccine manufacturers planning to adapt COVID-19 vaccines to coronavirus (SARS-CoV-2) variants.
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Global cooperation on COVID-19 medicine regulationCOVID-19 |International collaboration
Global cooperation on COVID-19 medicine regulation
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Global cooperation on COVID-19 medicine regulationCOVID-19 |International collaboration
Global cooperation on COVID-19 medicine regulation
ICMRA workshops underline international medicine regulators' commitment to align their align approaches for regulation of COVID-19 vaccines and medicines
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Public meeting on COVID-19 vaccines: Friday 26 MarchCOVID-19 |VACCINES
Public meeting on COVID-19 vaccines: Friday 26 March
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Public meeting on COVID-19 vaccines: Friday 26 MarchCOVID-19 |VACCINES
Public meeting on COVID-19 vaccines: Friday 26 March
Apply now to join the virtual room during our third public meeting, about the approval, safety monitoring and expected impact of COVID-19 vaccines or watch live on the day.
Latest news
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List item26/02/2021
First oral treatment for spinal muscular atrophy (SMA) recommended for approval
EMA has recommended granting a marketing authorisation in the European Union for the first treatment that can be given orally to patients with certain types of spinal muscular atrophy (SMA), a rare and often fatal genetic disease that causes muscle...
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List item26/02/2021 COVID-19
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 February 2021
Six new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended six medicines for approval at its February 2021 meeting. The Committee recommended granting a marketing authorisation for Evrysdi* (risdiplam), the first...
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List item25/02/2021 COVID-19
Adapting COVID-19 vaccines to SARS-CoV-2 variants: guidance for vaccine manufacturers
EMA has issued guidance outlining the requirements for manufacturers planning to modify their COVID-19 vaccines in order to address coronavirus (SARS-CoV-2) variants . Currently, three vaccines are authorised for use in the EU: Comirnaty , COVID-19...
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List item25/02/2021 COVID-19
International cooperation to align approaches for regulation of COVID-19 vaccines and medicines
Regulators around the globe are committed to aligning their regulatory requirements and addressing knowledge gaps to facilitate the development, authorisation and monitoring of safe, effective and high-quality vaccines and medicines against COVID-19...
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List item24/02/2021 COVID-19
EMA starts rolling review of Celltrion antibody regdanvimab for COVID-19
EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on the monoclonal antibody regdanvimab (also known as CT-P59), which is being developed by Celltrion, for the treatment of COVID-19. The decision to start the rolling...
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List item19/02/2021
Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 16-17 February 2021
CVMP opinions on veterinary medicinal products The Committee adopted by consensus a positive opinion for a marketing authorisation application for Credelio Plus ( lotilaner and milbemycin oxime combination) from Elanco GmbH, a new antiparasitic...
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