In Perfect Harmony? What will Brexit Mean for Regulatory Harmonisation
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.
Even EMA is distracted now that Brexit negotiations are underway. It has mooted plans to relocate its London headquarters to a new base on mainland Europe, despite encouragement to stay where it is. Whatever the final outcome, there is a good chance that at least a proportion of EMA’s 900 employees will review their position; some have already moved to other national agencies.
Right across the industry, skilled and specialist employees are worried about what happens next and where they will end up due to proposed new controls on resident permits and the free movement of labour across Europe. This comes at a time when a number of life sciences disciplines already face a talent gap, unable to fill growing teams because there of a lack of relevant experience on the market.
Maintaining stability & direction
So where does this leave regulatory compliance progress, especially around IDMP? Clearly it still serves everyone’s interests that this comprehensive international standard for product data exchange is supported and effective. But this is an ambitious project and it will take a lot of time to align all the right pieces, to deliver the desired quality. Whatever the delays and distractions, there is plenty of work to do now to prepare for what’s coming.
Forward-thinking firms are treating the hiatus as an opportunity to quantify the data preparation task that lies ahead, irrespective of the final destination. They can’t invest in specific IDMP software solutions until the final requirements and guidance have been published, but that doesn’t actually matter at the moment because the real effort required is in the initial groundwork. Whatever else is moveable, the need for consistent, accurate data will be a constant.
So how should companies move forward, to deliver something meaningful and of value that will serve them well in any eventuality?
Firms need to start by identifying all of the source content regulators might want, using known IDMP requirements as a guide; the different formats it is held in; and where it resides in the organisation. By creating a comprehensive inventory of files and file types, organisations can start to understand the size and scope of the task that lies ahead and begin to work out how they are going to tackle it.
Challenges include identifying and location the most up-to-date versions of documents and data. Very few organisations have a single, centralised system for holding all content, so bringing content together or trying to compare one version with another is unlikely to be easy. If the company has been subject to mergers and acquisition activity, and/or has amassed different legacy infrastructures over the years, all of this will add to the complexity of content management. Across the wider ecosystem, contract manufacturers, CROs, local representative offices, translation companies and other service providers will also need to be surveyed for contributing product information.
Letting technology take the strain
Beyond structured databases and formal document management systems, there are likely to be assets stored on people’s desktops, attached to emails, or kept in folders on servers without a common naming convention. If documents are PDFs, and do not contain selectable text (i.e. if they are simply outlines or images), their content will be difficult to extract and re-use – machines will be unable to read it. Use of non-Unicode fonts could also interfere with machine readability. Different languages, different spellings, corrupted content could all compromise consistency and accuracy as organisations work towards a definitive record of correct, current Product Information. Product Information Files may have been broken up by Regulatory teams too, multiplying the scope for variation.
The best way companies can tackle all of this reliably and efficiently is to harness automation wherever possible in preparing and checking content. It is now possible to accurately compare files even if they are in different formats, which can save organisations vast amounts of time.
Once all documents have been accounted for, cross-referenced and checked, and labelling and other patient content verified as correct and up to scratch, firms will be in a strong position to meet the requirements of IDMP. The final step will simply be to compare pre-compliant content with the new specifications once the last details have been finalised – ideally with an ability to filter and flag key words (controlled vocabularies) to ensure that quality checks will be efficient and reliable.
Whether the real driver is IDMP submission or something more operational that serves the needs of the business, the output will only ever be as good as the source content. So, whatever happens in the international market and whenever the final compliance deadlines fall, any groundwork companies do now will be well worth it.
This article appeared in www.epmmagazine.com June 13, 2017