Today, the European Commission adopted an implementing regulation setting out the rules for joint scientific consultations on medicinal products for human use at Union level, under the Health Technology Assessment (HTA) Regulation.
The implementing act provides detailed procedural rules for the joint scientific consultations, also known as scientific advice, covering:
- the submission of requests from health technology developers;
- the selection and consultation of stakeholder organisations and patients, clinical and other relevant experts;
- cooperation with the European Medicines Agency (EMA) where a health technology developer requests a joint scientific consultation to be carried out in parallel with EMA’s scientific advice process.
Joint scientific consultations enable health technology developers to exchange information with HTA bodies on their development plans for a medicinal product. They also enable developers to obtain guidance on the information, data, analyses and other evidence that are likely to be required from clinical studies for the joint clinical assessment of those medicinal products.
The HTA Regulation foresees the adoption of implementing acts, detailing the procedural rules for the different elements in the Regulation. This is the fourth implementing act adopted under the HTA Regulation.
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