Involving health technology assessment bodies early is also encouraged, which is possible via EMA's parallel consultations procedure. In a public health emergency, it can also be combined with a rolling review of data during the development of a promising medicine, to further expedite the evaluation.Ĭonditional marketing authorisation is the most appropriate tool to grant access to COVID-19 vaccines to all EU citizens at the same time and to underpin mass vaccination campaigns.įor information on authorised COVID-19 medicines and those currently undergoing evaluation, see Treatments and vaccines for COVID-19.įor more information on EMA’s expedited evaluation procedure for COVID-19 vaccines in the EU, see COVID-19 vaccines: Scientific evaluation and approval: Accelerated evaluation.įor guidance for developers of COVID-19 treatments and vaccines, see COVID-19 guidance: evaluation and marketing authorisation.ĮMA advises applicants to discuss their development plans with the Agency via scientific advice or protocol assistance early in the development process. It allows regulators to grant a marketing authorisation as soon as sufficient data becomes available to demonstrate that the medicine's benefits outweigh its risks, with robust safeguards and controls in place post-authorisation. This is in line with EU legislation which foresees that conditional marketing authorisation is used as the fast-track authorisation during public health emergencies to speed up approval and save lives. It can then be renewed for unlimited validity.Īs for any medicine, if new data show that the medicine’s benefits no longer outweigh its risks, EMA can take regulatory action, such as suspending or revoking the marketing authorisation.ĮMA can also take regulatory action if the company does not comply with the imposed obligations.ĭuring the COVID-19 pandemic, the conditional marketing authorisation procedure is being used to expedite the approval of safe and effective COVID-19 treatments and vaccines in the EU. The marketing authorisation can be converted into a standard marketing authorisation (no longer subject to specific obligations) once the marketing authorisation holder fulfils the obligations imposed and the complete data confirm that the medicine's benefits continue to outweigh its risks. These obligations could include completing ongoing or new studies or collecting additional data to confirm the medicine's benefit-risk balance remains positive.ĮMA publishes the conditions of the marketing authorisation in the medicine's European public assessment report. Once a conditional marketing authorisation has been granted, the marketing authorisation holder must fulfil specific obligationswithin defined timelines. the benefit of the medicine's immediate availability to patients is greater than the risk inherent in the fact that additional data are still required.Ĭonditional marketing authorisations are valid for one year and can be renewed annually.the medicine fulfils an unmet medical need.it is likely that the applicant will be able to provide comprehensive data post-authorisation.the benefit-risk balance of the medicine is positive.EMA's CHMP may grant a conditional marketing authorisation for a medicine if it finds that all of the following criteria are met:
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