European Medicines Agency releases best practice guidance on parallel scientific advice with health-technology-assessment bodies
Guidance to facilitate early dialogue between regulators, health-technology-assessment bodies and medicines developers
The European Medicines Agency (EMA) has published today for public consultation best practice guidance for pilot parallel scientific advice procedures involving the EMA and health-technology-assessment (HTA) bodies.
The document is a key outcome of the EMA-HTA workshop on parallel scientific advice, which took place in November 2013 and brought together over 280 representatives from, among others, the European Commission, European regulators, HTA bodies, the European Network for Health Technology Assessment (EUnetHTA), the pharmaceutical industry, payers, patients and healthcare professionals. The report of the workshop is also published today.
“I believe that this guidance can be a major tool for medicines development, which will help new medicines with a positive benefit-risk balance and expected added value to reach patients in a faster and more transparent way,” said Tomas Salmonson, Chair of the Agency’s Committee for Medicinal Products for Human Use (CHMP), at the November workshop.
The draft guidance sets out the different phases of the process for EMA-HTA parallel scientific advice and highlights ideal timelines and actions for all parties, including HTA bodies, the EMA and applicants undertaking a parallel advice procedure.
The document has been drafted in collaboration with HTA bodies based on the experience gained so far with the EMA-HTA parallel scientific advice pilot project and on the input provided by stakeholders during the November workshop.
Stakeholders are invited to provide comments on the proposed process by 14 July 2014, using the online form accessible via the draft guidance document.
The EMA established a pilot project for parallel scientific advice with HTA bodies in 2010, to allow medicines developers to receive simultaneous feedback at an early stage from both regulators and HTA bodies on their development plans for new medicines.The aim of this early dialogue is to facilitate agreement upon a development plan that generates data that both the EMA and HTA bodies can use to determine a medicine's benefit-risk balance and value, respectively. This strong interaction is critical to enable innovation to reach patients, and ultimately for the benefit of public health.
The EMA is also associated with the Shaping European Early Dialogues for health technologies (SEED) consortium, which is financed by the European Commission to explore a number of scenarios for conducting early dialogues.
The outcome of the EMA-HTA parallel scientific advice pilot, which is still running, the public consultation on the draft process, as well as the results from the SEED project, will be taken into consideration to best meet the objective of the early dialogue for health-technologies exercise at the EU level.
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- Health-technology-assessment bodies
- Scientific advice and protocol assistance
- European Medicines Agency / health-technology-assessment-body workshop on parallel scientific advice in drug development (26/11/2013)
- European Network for Health Technology Assessment (EUnetHTA)
- Shaping European Early Dialogues for health technologies (SEED)
- Draft best practice guidance for pilot European Medicines Agency health technology assessment parallel scientific advice procedures (08/05/2014)
- Report from the European Medicines Agency / health-technology-assessment-body workshop on parallel scientific advice in drug development on 26 November 2013 (08/05/2014)