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Parliamentary questions
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27 April 2021
E-000324/2021(ASW)
Answer given by Ms Kyriakides
on behalf of the European Commission
Question reference: E-000324/2021

In December 2020, the European Medicines Agency (EMA) was the subject of a cyberattack. Some of the unlawfully accessed documents including email correspondence were made public through the Internet and were subsequently picked up by some media outlets. EMA swiftly launched a full investigation, in close cooperation with law enforcement and other relevant entities.

EMA continues to fully support the criminal investigation related to the cyberattack led by law enforcement authorities, in cooperation with other entities and will continue to provide information in due course, to the extent possible, given its duty towards the ongoing investigations.

EMA and the European medicines regulatory network remained fully functional and timelines related to the evaluation and approval of COVID-19 medicines and vaccines have not been affected by the cyberattack. EMA is transparent about the start of their COVID-19 related assessments and the expected timelines for their completion.

The Commission, as the authorising body for all centrally authorised products, takes the legally binding decision based on EMA’s recommendation. Thus, the Commission follows closely the work of EMA and its Committees but does not exert any pressure or otherwise influence their independent scientific role.

EMA’s human medicines committee (CHMP) assessed the BioNTech/Pfizer and Moderna vaccines on the basis of robust data on their quality, safety and efficacy. The Commission authorised both vaccines for the European Union market based on EMA’s independent scientific evaluation.

Last updated: 27 April 2021Legal notice - Privacy policy