Home Tech European Council gives the go-ahead to new healthtech assessment rules

European Council gives the go-ahead to new healthtech assessment rules

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The European Council has given the green light to a new, harmonised regulation on health technology assessments across EU member states.

Under the EU Health Technology Assessment (HTA) joint clinical assessments and joint scientific consultations on health technologies will be enabled between EU member states, to allow for more rapid assessments of healthcare technologies.

Key information will be shared across member states to national health authorities, meaning that only one healthcare technology assessment submission at EU level is needed for a specific product from a healthcare technology company.

The regulation still needs to be adopted by the European Parliament before it will be published in the EU Official Journal. It will start to apply three years after its entry into force (which happens on the twentieth day following its publication).

WHY IT MATTERS

Health technology assessment evaluates the social, economic, organisational and ethical…

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