Global regulators publish joint statement for healthcare professionals: How COVID-19 vaccines will be regulated for safety and effectiveness

News Category: Regulatory news

Date: 17/02/2021

Regulatory authorities from around the world, including the HPRA, have come together to publish a joint statement to inform and help healthcare professionals answer questions about the evaluation, approval and monitoring of safe, effective and high-quality COVID-19 vaccines.

In their joint statement, which was developed through the International Coalition of Medicines Regulatory Authorities (ICMRA), international regulators state that the public can have confidence in the rigour of the process used to scientifically evaluate the safety, efficacy and quality of vaccines before they are approved. They also reiterate that regulators continue to rigorously monitor the safety of vaccines after approval for use. ICMRA members emphasise that regulators, in collaboration with public health authorities, are able to take decisive action if and when a safety issue is identified.

ICMRA recognises that many people want more information about the development, regulatory review and safety monitoring of COVID-19 vaccines. In response, it has developed this statement to support healthcare professionals when talking to members of the public to reassure them that the regulatory processes for the authorisation and safety monitoring of COVID-19 vaccines are robust, independent and driven by patient and public health needs.

Further details can be found on the ICMRA website:

The HPRA is a member of ICMRA, which acts as a forum to support international cooperation among medicines regulatory authorities. Further details on the role and strategic initiatives of ICMRA can be found on

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