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.
So where does this leave the regulatory compliance progress, especially around ISO Identification of Medicinal Products (IDMP)? Clearly, it still serves everyone’s interests that this comprehensive international standard for product data is supported and effective. But IDMP is an ambitious project. It will take a lot of time to align all the pieces to deliver the desired quality.
Worries about widening skills gaps risk detracting further from companies’ progress. If teams are overstretched, it is not a good time to be adding to people’s workloads. If staff are moving to new countries, language barriers or retraining needs could slow down their ability to adapt and get back up to speed. So companies need to think laterally about how to ease the transition and maintain productivity.
In terms of moving forward with the vital groundwork that’s needed in preparation for IDMP, companies need to keep sight of their own potential benefits from compliance (beyond improved patient safety), which include significant efficiency gains as it becomes easier to manage information and submissions. It makes sense to make data preparations efficient too, then, especially with the current pressures on the teams responsible.
Letting automation take the strain
Harnessing automation is one way to minimise the burden on skilled personnel. When it comes to organising and verifying definitive source documents, checking for accuracy and currency, and comparing these across different languages, file and font types, there are now sophisticated tools that can help relieve the pressure on already time-starved teams – taking care of the heavy lifting so the overseeing professionals only need to proof content once, as a final check.
Compliance with US FDA and other international standardisation requirements, plus separate UK processes which may be required after Brexit, should be easier to manage too once the basics are in place. So the effort to put it now in order to get internal information aligned – despite changing deadlines and political distractions – should pay dividends later.