Data Harmonisation in a Fragmenting Market: Brexit & IDMP

Discord rather than harmony seems to prevail internationally at the moment, which seems at odds with plans to collectively raise industry standards and safety across the world. Brexit negotiations risk destabilising the EU, and markets from the US to Asia are becoming increasingly unpredictable, whatever the intentions of global standards promoters. For now it is hard to know how global pharma regulatory requirements might be affected by all of the current political instability.

No one would argue that the pharma industry and the public at large have much to gain from harmonised product information, reporting and safety standards, or from improved traceability. But the worry is that too many external distractions may undermine the positive momentum.

EMA is planning to relocate its headquarters, with implications for service continuity as up to 900 staff re-evaluate their positions. Concerns about new restrictions on the movement of labour have unsettled all sorts of skilled and specialist employees, at a time when a number of life science disciplines already face a talent gap, unable to populate expanding teams because there is a lack of relevant experience on the market. Regulatory, quality, safety, pharmacovigilance skills are in high demand, and concerns about the redrawing of borders is doing nothing to alleviate the recruitment and talent retention challenge. In all probability, companies will look to service providers to meet as best as possible the market requirements.

Avoiding distraction

So where does this leave the regulatory compliance progress, especially around ISO Identification of Medicinal Products (IDMP)?

This article is taken from , April 27, 2017

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