EU regulators have produced the first fruits of their ambitious “big data” project aimed at ensuring that the EU drug regulatory system can make full use of the rapidly increasing volume and complexity of data being gathered across multiple settings in the healthcare area.

The BioIndustry Association’s latest Brexit webinar looked at issues such as companies’ drug filing strategies in a no-deal scenario as well as the costs that industry is likely to incur as a result of changes to regulatory processes.

The government has said it is prepared to discuss the terms of supplementary protection certificates under a UK-only regime if there is a no-deal Brexit, but concerns also linger over the start dates for regulatory data protection.

The National Institute for Health and Care Excellence does not agree with assertions by the US pharmaceutical industry that its HTA process are “rigid” and “fail to recognize the full value of innovative medicines.”