European Commission adopts rules for joint clinical assessments

The European Commission has adopted joint clinical assessment rules detailing how national health systems should review products in parallel to ensure they get to market faster in individual member states.

The Commission announced on 23 May that it had finalized the rules that it says will help member states conduct joint clinical assessments of medical products after receiving EU marketing authorization. The rule was adopted under the Regulation on Health Technology Assessment (HTA) and addressed how the evidence submitted for marketing can be used by national health authorities to assess the product by national health authorities.

The Commission said the HTA regulation offers a new and innovative way for regulators to harness and pool expertise from across the region to compare the effectiveness of newly authorized medicines to those already on the market.

Stella Kyriakides, European commissioner for health and food safety, said adopting the rule is a "major milestone" for the EU as it tries to ensure better access to evidence-based healthcare and novel technologies across the region.

"Innovation and technology are key drivers for a strong European Health Union and for bringing medicines to patients," she added. "We want these medical technologies to be reaching our patients as quickly and equally as possible."

While the rule has been finalized, joint clinical assessments for drugs with new active substances to treat cancers and for advanced therapy medicinal products will not take effect until January 2025. It is also the first of six rules under the HTA regulation that are planned to be adopted this year.

The rule states that EU regulations have created a framework that details procedures for how Member States should work together on the Union level through a Member State Coordination Group on Health Technology Assessment (Coordination Group) to review outcomes from joint clinical assessments. The rule requires that clinical assessments begin at the same time as the centralized procedure after the European Medicines Agency (EMA) confirms it has received a valid application for marketing authorization or a variation in an existing marketing authorization.

The rule also says that health technology developers should submit the necessary information to the Commission simultaneously with their submission to EMA to allow the joint clinical assessment. After the Commission grants marketing authorization, the Coordination Group must endorse the joint clinical assessment report within 30 days.

“The joint clinical assessment is to be discontinued, for example, where an application for a marketing authorization or for a variation to the terms of an existing marketing authorization is withdrawn, or where the outcome of the centralized procedure is negative for the application for a marketing authorization or for a variation to the terms of an existing marketing authorization,” the rule states.

“Therefore, the Coordination Group should be informed of submissions of valid applications for marketing authorization and for a variation to the terms of existing marketing authorizations of medicinal products falling within the scope of [regulation] and of updates on steps in the centralized procedure, including changes in the envisaged timelines.”

According to the final rule, health technology developers should also be informed that a joint clinical assessment of their product has started. They should also be told about how the assessment is progressing and their re-initiation under regulation.

“The health technology developer should also be informed of the decision of the Coordination Group to include the update of the joint clinical assessment in its annual work program, pursuant to [regulation],” the rule added.

Statement on joint clinical assessment rule

European Commission adopts rules for joint clinical assessments

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