Digitalisation and fastness are accelerating the pace of the regulatory world

News • 08.10.2018

This year´s annual Topra regulatory symposium was held in Stockholm on October 1-3. DRA Consulting participated both with an exhibition stand and by attending excellent presentations covering hot topics.

In addition to Brexit the following issues are now on the agenda:

1. New innovations for patient use are required faster. Marketing authorisation only is not enough; the economic benefit of the product must also be proven. Only then will society be willing to share the costs of using the medicine and medicines will become available for patients. At the same time the nature of information produced to support marketing authorisations and economic value is partly changing. Do authorities know how to evaluate Real Word Data?
2. Electronic product information will become available for patients in the EU, but when and in what form is still under discussion. The package information leaflet in printed form is still required by current EU legislation. Often, the information is no longer up to date at the time the product package becomes available for patients. The Nordic countries have excellent up-to-date electronic databases with product information approved by regulatory authorities. This information is also available via mobile apps and the information is easy to search and use. Could this be a good model even for other parts of Europe?
3. Changes in the approval of medicine/device fixed combination products present challenges to the pharmaceutical industry and the authorities. Previously device documentation has often been evaluated during the marketing authorisation application procedures only. In the future, an evaluation by a Notified Body will also be required. When can practical guidance from the authorities be expected?

If you would like to hear more about these topics, please e-mail .