by Thomas Meek at the TOPRA annual symposium
LONDON, Oct 3 (APM) - New European clinical trial regulations due to come into operation in 2018 will bring a "new paradigm" for the industry, Novartis's Judith Creba has said.
Creba, who is executive director, EU regulator strategy at the Swiss pharma, told a conference last week that much work still needs to be done on both a member state level and by the European Medicines Agency (EMA) before the implementation of the regulation, which was published in April 2014, in order to bring greater harmonisation and transparency to the regulatory process for medicines.
Central to the regulation is the establishment of a European Union (EU) portal and database set up by the EMA, which will serve as the single entry point for submitting clinical trial information in the EU. The portal and database is due to be ready in October 2018, after an audit starting in August 2017.
Creba, who was speaking at the TOPRA symposium in Amsterdam, The Netherlands, on Thursday, described the portal as the "new system through which all submissions, notifications and publishing clinical trial information will be done".
Updating on the progress of the portal and database, Isabelle Clamou, regulatory affairs director, global regulatory and R&D policy at Amgen, urged pharma companies to be ready for the move to the new process.
"If you think about it, we think about our study plans one year in advance, or even more in advance. So we need to have our submissions ready and all our documentation ready months in advance. So although it's not operational until October 2018 we have to be organised and ready almost one year ahead at the end of 2017," said Clamou, who was speaking in the same session at TOPRA.
"So the availability of information about the key documents for the portal and the database are very important. It's not like we have some time. Be mindful not to slip."
Clamou said the portal and database are being developed by the EMA with input from all stakeholders, including pharma companies, academics and contract research originations.
The development process includes the creation of 'use cases', which give step by step guides to how to use the system for different functions. These have been shared with stakeholders, but are not available publicly.
The EMA is using feedback from these cases to inform the set up of the system and to fix bugs. "It is very much leaning by doing," said Clamou.
The national member states of the EU also have work to do to transition to the new regulations, with Clamou mentioning that several countries have established pilots to figure out how the system will work on a national level.
Countries with active pilots include France and Germany, while Belgium and the UK have plans under consideration.
Clamou said these pilots are useful as they help the industry understand how to be organised for the future situation.
They are also beneficial for member states, said Clamou, as they help teach national regulatory organisations how to share information and do assessments.
Member states are also taking steps to change their laws to take into account the new requirements of the regulations.
Clamou said that Spain was the country most ahead of the game in this context, with changes about to be implemented after receiving a royal decree. Some elements cannot be implemented at the moment as they are dependent on the portal and database, clarified Clamou, but the country is working according to the current regulation provisions.
Denmark also has a royal decree for adopting the new regulation, although this is not due to come into force until 2018.
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