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The Agency works by: developing guidelines and setting standards; coordinating the monitoring of pharmaceutical companies' compliance with their pharmacovigilance obligations; contributing to international pharmacovigilance activities with authorities outside the EU; informing the public on the safety of medicines and cooperating with external ...
Throughout the COVID-19 pandemic, EMA has sought to expedite the development of effective medicines and vaccines against COVID-19. During the public health emergency, EMA ensured the assessment and safety monitoring of COVID-19 medicines were prioritised, so that patients in Europe could access high quality, safe and effective medicines.. EMA worked closely with its partners in the European ...
The European Medicines Agency (EMA) is responsible for the scientific evaluation of centralised marketing authorisation applications (MAA). Once granted by the European Commission, the centralised marketing authorisation is valid in all European Union (EU) Member States, Iceland, Norway and Liechtenstein. Human Regulatory and procedural guidance.
15 de feb. de 2024 · The European Medicines Agency (EMA) monitors the safety of COVID-19 vaccines authorised in the European Union (EU) extremely carefully. With hundreds of millions of people already vaccinated in the EU, this enables the continued detection of any rare side effects. Human COVID-19 Pharmacovigilance Vaccines. Updated on 15 February 2024:
20 de ene. de 2022 · Parliament endorsed the provisional agreement reached with the Council last year on increasing the powers of the EU’s medicines regulator with 655 votes in favour, 31 against and 8 abstentions.. The European Medicines Agency (EMA) will be better equipped to monitor and mitigate shortages of medicinal products and medical devices considered to be critical in order to address public health ...
The Committee for Medicinal Products for Human Use (CHMP) is the European Medicines Agency's (EMA) committee responsible for human medicines. It plays a vital role in the authorisation of medicines in the European Union. The committee meets once a month. EMA publishes agendas, minutes and highlights of its plenary meetings.
The overview below summarises the characteristics of the COVID-19 vaccines authorised in the EU: Platforms - the type of technology used to develop the vaccine. Strains - the type of virus the vaccine targets, i.e. 'wild-type' (original), a variant or a sub-variant of the virus. Use - whether the vaccine is for primary or for booster vaccination.
