In Europe, the 2016 deadline for complying with the IDMP standard is fast approaching. Are pharma companies ready?
The Identification of Medicinal Products (IDMP) standard is a highly detailed, cross-functional ontology designed to harmonize the collection, formatting and transmission of medicinal product information to regulatory authorities. The initiative has enjoyed cross-border support, with the regulatory authorities of US, Canada and Switzerland all publically committing to adoption at some point in the future and Japan, Australia, Russia and Iran all expressing at least some level of interest.The European Medicines Agency (EMA) has already mandated compliance by July 1, 2016.
With the deadline fast approaching, most organizations have recognized that achieving compliance will be a significant undertaking, affecting numerous business units, information systems, processes and technologies. In general, the scale of compliance challenges increases with:
The size of the company’s product portfolio.
The number and variety of different systems and processes in use to manage data.
The presence of diffuse or poorly connected departments.
The number of third-party providers such as contract research and manufacturing organizations.
The presence of affiliate companies.
In addition, unpredictable and shifting external factors might introduce an extra level of difficulty:
The final scope of mandatory data will only be known when those final guidelines are available, which is not expected until June 2015.
Even once overarching ICH implementation plans become available much will still be determined by regional guidance. Any concurrent regional implementations of differing scope and timelines will compound the organizational challenge.
These guidelines will drive, and perhaps disrupt, the development and release of third-party software solutions to actually send IDMP submissions to the authorities.
Although software solutions for submitting the IDMP data are not yet available, companies cannot delay getting started on their IDMP journey because they face a huge task upgrading internal systems and processes to collate, validate and store existing data. The short- to medium-term challenge is to determine where in your organization the required data lives today, develop a common language and understanding of the data, and to define the processes and systems that will permit its aggregation.
In my next post, I’ll discuss a series of steps companies can take to prepare for the 2016 deadline.