EMA Publishes Report on Parallel Scientific Advice Pilot

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 03-31-2016 14:04


The European Medicines Agency (EMA) has published a report on its pilot on parallel scientific advice with health-technology-assessment (HTA) bodies that finished at the end of March 2016. This initiative that allows developers of new medicines to receive simultaneous feedback on their development plans from both regulators and HTA bodies is being continued.

Since its start in July 2010, a total of 63 parallel scientific advice procedures were completed by December 2015. Fourteen applications for the parallel scientific advice procedure are currently registered for 2016 (four are ongoing, two are completed and eight are due to start). Take-up of parallel scientific advice increased significantly, as the number of procedures almost tripled in 2015 compared to the previous year.

The report also indicates that a high level of alignment between the requirements of regulators and HTA bodies was achieved with the parallel scientific advice procedure. An analysis of a subset of 31 parallel scientific advice procedures completed between the start of the pilot and May 2015 showed that in approximately 70% of cases, one clinical trial design or one development program could satisfy the evidence needs of regulators and HTA bodies.

Following regulatory approval, a growing number of European Union member states have systems in place that provide for HTA bodies to give recommendations on whether a medicine can be paid for by the healthcare system, taking into account the best possible use of available resources and national legislation. Parallel scientific advice is one of the agency’s key initiatives to improve patient access to important new medicines because it ensures that the envisaged clinical trials generate appropriate data for regulators and HTA bodies and allow the assessment of both benefit-risk balance and added value. This can reduce delays between a medicine’s marketing authorization and decisions on reimbursement. Following the completion of the pilot, parallel scientific advice with HTA bodies and other relevant stakeholders is now routinely offered as part of the agency’s scientific advice activities.

The EMA has also published a consolidated best practice guide which sets out the different phases of the process for regulatory-HTA parallel scientific advice and highlights ideal timelines and actions for all parties involved. This guide, together with a document that gives an overview of the HTA bodies that have participated in EMA’s parallel scientific advice initiative so far, provides information on the procedure.

Source: European Medicines Agency


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