Step 1. Requests for joint scientific consultations
For health technologies that are likely to be the subject of joint clinical assessment according to Article 7(1) and where the clinical studies and clinical investigations are still in the planning stage (Article 16(2)), health technology developers may request a joint scientific consultation (Article 17 (1)).
JSCs can be requested for new health technologies or when an existing health technology is being developed for a new indication.
HTDs of medicinal products interested in a parallel scientific advice from the EMA must request this at the same time as applying for a JSC.
HTDs will also benefit from patient and clinical expert contributions, who will be involved in the parallel consultation process and their opinion will be reflected in the final result documents.
The objective of this parallel process is to allow medicine developers to obtain feedback from regulators and HTA bodies in Member States on their development plans to support decision-making and to help generate optimal and robust evidence that satisfies the needs of both regulators and HTA bodies at the same time.
The parallel processes will result in two documents, one scientific advice letter from EMA and one Joint Scientific Consultation outcome document from the JSC subgroup, which are both not binding. However, experience shows that it is advantageous to follow the advice and recommendations given.
Medical Devices
Similarly, health technology developers of medical devices – interested in parallel consultation with an expert panel – may request this parallel consultation when submitting the JSC request (Article 17(2)).