2016: A critical year for compliance—and combative manoeuvres
Summary2016: A critical year for compliance—and combative manoeuvres
As 2015 draws to a close—and with a number of important regulatory deadlines set to converge during the year ahead, data preparation efforts across the life sciences industry are reaching a peak. But what benefit do companies expect for their pains? wonders ProductLife Group’s Chief Operating Officer, John Farrell
Data centralisation and harmonisation efforts are the preoccupations of regulatory teams across the life sciences industry because regulatory demands around product and process transparency have intensified. Activity reached a peak in 2015 as companies looked down the barrels of approaching deadlines, by which points a whole range of data must have been captured, managed, submitted, and updated in particular ways. Life sciences companies should see benefit, too, from their investments. But it depends on the extent to which they have treated data projects holistically rather than as a series of reactive and costly initiatives geared to keeping regulators happy and patients safe.
Coordinated product identification, safety record updates, and clinical trial recording
Companies’ primary incentive for getting their information management processes and systems in order in 2015 has been the Identification of Medicinal Products (IDMP), whose original deadline for adherence (with new standards for recording product information) was 1 July 2016. And even though the European Commission recently agreed to a phased transition instead, the IDMP’s demands are no less pressing. And so, rather than breathe easy based on the more-relaxed, transition timetable, companies should take full advantage of the slight reprieve to get more from their data management programmes—especially when IDMP is only the tip of the iceberg in regulatory terms. From June 2016, companies will have to use a special repository for periodic safety update reports, accessed via the European Medicines Agency’s eSubmission Gateway.
Then there’s the agency’s Individual Case Safety Report database, which marketing authorisation holders (MAHs) will also have to use from 2016. The database will remove some of the duplication associated with submission of information to multiple authorities, but MAHs will now have to submit more data—including information on nonserious reactions to drugs. A lot of cross-checking will also be involved, thereby adding to the case for organisations to have good, solid systems and processes in place.
A tightening of clinical trial reporting is also at hand: a new European Union submission portal and database are expected to be in place by 2017 for all European application dossiers, for information on assessments and follow-up, and for certain information on results of trials.
Good data is everyone’s responsibility
As the completeness, quality, and format of data become key to all sorts of strategic initiatives intended to keep patients safe, the responsibility for that data extends right across and throughout life sciences organisations. Although regulatory affairs team members have been the primary people assigned to the task, compliant data recording and handling rely on cooperation from a company’s every corner.
Manufacturing processes, too, are under scrutiny. As of November 2015, all medicinal products manufactured in shared facilities and intended for the European market are subject to strict new cross-contamination guidelines. In addition, from March 2016, companies will have to ensure they can identify and trace materials right back along their supply chain. Cosmetic products are under intensified scrutiny too, with stricter requirements around the safety profiles of substances used in cosmetic products.
All of those new demands, coupled with calls for global standardisation, create clear obligations for life sciences companies to develop holistic information-capture and information-management processes. That process development can only help them in their own endeavours not only to reduce risk but also to become able to meet the business challenges and deal with the market pressures they face every day—from expanding their portfolios to entering new markets.
The year 2016 shouldn’t be one in which companies just tick boxes; it should be a year for doing things differently.
About the author
John Farrell is Chief Operating Office at ProductLife Group