In Imperfect Harmony? What will Brexit Mean for Regulatory Harmonisation

Brexit Pharma

The global market is currently experiencing a turbulent period, as national elections continue, governments change and the UK edges closer to Brexit. One of the practical concerns for life sciences is how this might affect the regulatory landscape, and momentum behind specific regulatory developments such as the phasing in of ISO Identification of Medicinal Products (IDMP).

Although the benefits of harmonised product information, reporting and safety standards, and improved traceability internationally, are still in everyone’s interests, the worry is that authorities’ attentions will become diverted by other priorities. Where life sciences firms are required to invest significant amounts of time and budget in preparing for emerging requirements, there is a need for clarity and reassurance.

European Medicines Agency (EMA) timelines for IDMP have already shifted, with an impact on firms’ preparations. At this rate, even though they have had longer to get their processes and data in order, they risk a last-minute rush because they haven’t maintained focus. This could jeopardise the quality of their output, as well as any benefits of their own derived from improvements to the way they manage data.

This article is taken from EPM.com June 13, 2017

Read article online: http://www.epmmagazine.com/opinion/in-imperfect-harmony/