LONDON, July 4 (APM) - The European Medicines Agency (EMA) on Tuesday announced plans to streamline the process for drugs to undergo parallel consultation from the regulator and healthcare technology assessment (HTA) bodies of EU member states.
The EMA said it is working with the European Network for Health Technology Assessment (EUnetHTA) to provide a 'single gateway' for requests for parallel consultation on what plans are needed to gather evidence to support decision-making on both marketing authorisation and market access.
This will replace the existing tool for parallel scientific advice by EMA and HTA bodies, which required medicine developers to contact the HTA bodies of member states individually.
EMA executive director Guido Rasi said in a statement: "Enabling patients' access to medicines is no longer a job for regulators alone. Today, we need to work with all decision-makers in healthcare to make sure that medicines that can make a real difference to people's lives can actually reach them.
"Our work with EUnetHTA aims to align our respective requirements as much as possible so that developers can generate one set of data that allows the assessment of both the benefits and risks of a medicine and its added value."
Pharma companies that want to request parallel consultation will need to notify simultaneously EMA and EUnetHTA of their intention to request. EUnetHTA's recently created early dialogue secretariat will then coordinate the involvement of the HTA bodies that will take part in the parallel advice, taking into account the pharma's preferences.
The EMA said this new system will provide several benefits, including increased mutual understanding and problem-solving ability through a more structured interaction between EMA and HTA bodies, and improved coordination with and greater participation of HTA bodies.
EUnetHTA's Wim Goettsch said: "As clinical studies form the evidence basis for both regulators and HTA bodies, our strengthened involvement in early dialogues and our collaboration with EMA will support the generation of evidence that better meets the needs of HTA bodies and will support informed decisions at national level."
The EMA has been working with HTA bodies for several years to bring regulatory and HTA efforts closer, launching a pilot in 2010 under which drug developers could receive simultaneous feedback from both regulators and HTA bodies on their development plans for new medicines (APMMA 20571).
At the same time, EU HTA bodies have come together under the banner EunetHTA, which has completed two joint actions to put into practice effective and sustainable HTA collaboration in Europe and strengthen the practical application of tools and approaches to cross-border HTA collaboration.
It is now in the middle of a third joint action which aims to define and implement a sustainable model for scientific and technical cooperation on HTA in Europe by 2020 (APMMA 50246).
The EMA has been working closely with EUnetHTA over this period, saying in April last year that their collaboration is reducing duplication and streamlining the entire drug development process (APMMA 47372).
Last month, the EMA's Dr Hans-Georg Eichler told APM that the number of parallel scientific advice meetings held at the EMA grows month on month. "I would argue this is almost routine procedure," he said (APMMA 53406).
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