EMA

On 18 February 2021, the EMA shared its latest publications on COVID-19 vaccines (check the links below).

• AstraZeneca European Public Assessment Report (EPAR)
• EMA receives application for conditional marketing authorisation of COVID-19 Vaccine Janssen
• EMA starts rolling review of CureVac’s COVID-19 vaccine (CVnCoV)
• Clarification on Sputnik V vaccine in the EU approval process
• EMA preparing guidance to tackle COVID-19 variants.

We would like to remind you to check EMA’s dedicated webpage on COVID-19 for the latest updates.

• EMA and the national competent authorities (NCAs) in EU Member States have prepared a safety monitoring plan for COVID-19 vaccines. The plan outlines how relevant new information emerging after the authorisation and uptake of COVID-19 vaccines in the pandemic situation will be collected and promptly reviewed. (13 November 2020)
• EMA has also published guidance to support pharmaceutical companies’ preparation of risk management plans (RMPs) for COVID-19 vaccines. As for any medicine, companies applying for a marketing authorisation for COVID-19 vaccines must submit RMPs. The RMP explains how the company must monitor and report on the safety of the vaccine once authorised, and what measures it must put in place to further characterise and manage risks. RMPs are updated as new information becomes available. (13 November 2020)
• EMA exceptional measures for COVID-19 medicines (2 November 2020): During the COVID-19 pandemic, the European Medicines Agency (EMA) is  implementing exceptional measures to maximise the transparency of its regulatory activities on treatments and vaccines for COVID-19 that are approved or are under evaluation.

  Further information on EMA website: 

  https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/transparency-exceptional-measures-covid-19-medicines#comparison-with-standard-transparency-section
• Recommendations by the Enpr-EMA working group on trial preparedness for sponsors, principal investigators and triallists involved in paediatric clinical trials now available:                                                                                                                                            https://www.ema.europa.eu/en/documents/other/preparedness-medicines-clinical-trials-paediatrics-recommendations-enpr-ema-working-group-trial_en.pdf
• The new revision of the guidance (v3) is now available on EudraLex-10 (28 April 2020):                                                                                 https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf
• Related press release announcing the publication can be found here (28 April 2020):                                                               https://ec.europa.eu/commission/presscorner/detail/en/ip_20_759
• EMA COVID-19 Workshop: "Global regulators discuss observational studies of real world data for COVID-19 medicines" (7 April 2020) -https://www.ema.europa.eu/en/news/global-regulators-discuss-observational-studies-real-world-data-covid-19-medicines
• EMA Press Release: "New measures to support availability of medicines used in the COVID-19 pandemic (6 April 2020)" -https://www.ema.europa.eu/en/news/eu-authorities-agree-new-measures-support-availability-medicines-used-covid-19-pandemic
• EMA Press Release: "CHMP recommendation for compassionate use programmes of remdesivir for treating COVID-19" -https://www.ema.europa.eu/en/news/ema-provides-recommendations-compassionate-use-remdesivir-covid-19
• "COVID-19 - Message from Enpr-EMA & EU authorities guidance on how to manage CTs during the pandemic" (27 March 2020)-      https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf
• "Points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials" (25 March 2020) - https://www.ema.europa.eu/en/documents/scientific-guideline/points-consider-implications-coronavirus-disease-covid-19-methodological-aspects-ongoing-clinical_en.pdf
• EMA Communication: "Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic" -https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf
• EMA Communication: "Implications of coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials" -https://www.ema.europa.eu/en/implications-coronavirus-disease-covid-19-methodological-aspects-ongoing-clinical-trials
• EMA Communication: First regulatory workshop on COVID-19 facilitates global collaboration on vaccine development -                                                                 18 March 2020: First regulatory workshop on COVID-19 facilitates global collaboration on vaccine development
• "EMA/CHMP statement on Call to pool research resources into large multi-centre, multi-arm clinical trials to generate sound evidence on COVID-19 treatments  published today" -                                                                                                                                                                                                                                https://www.ema.europa.eu/en/news/call-pool-research-resources-large-multi-centre-multi-arm-clinical-trials-generate-sound-evidence