In a previous blog I looked at some of the EU regulations that are disrupting the Life Sciences sector. One area of change with truly global implications is the implementation of the ISO Identification of Medicinal Products (IDMP).
The EU is the first region to adopt IDMP but the US, Japan and the rest of the world are following the same route. Although the EU has delayed its timetable for the implementation of IDMP until after 2020, complying with the standards is challenging. Taking an enterprise approach will help drive the data standardization and quality needed to meet your IDMP requirements.
On the face of it, IDMP implementation should more straightforward for Life Science companies than other EU regulations such as GDPR or the EU Medical Device Regulation (EU MDR). If you take IDMP as primarily an exercise in Master Data Management then companies have gone through the process with customer master data to comply with Healthcare Professionals and Organization (HCP/O) transparency reporting requirements. In addition, medicinal product data standardization is a large part of the EVMPD and XEVMPD pharmacovigilance legislation. But, looks can be deceiving.
First of all, there is the sheer volume of data – in different data formats, stored in different data silos – that has to be brought together, cleansed and standardized. Secondly, the scope of IMDP implementation is much larger than for XEVMPD – Deloitte suggests it’s three to five times larger in terms of the effort required. In addition, Master Data Management is only part of IDMP and, conversely, IDMP is only part of the Master Data Management strategy for a company.
Finally, implementing IDMP is likely to highly demanding and costly for Life Sciences firms as it has to be addressed in conjunction with a raft of complementary and inter-linked legislations such as the Falsified Medicines Act and the Clinical Trials Directive.
Getting to grips with IDMP
ISO IDMP was originally devised to improve patient safety by improving and tracking adverse drug reactions. It’s designed to give regulators visibility into the development, registration and lifecycle of medicinal products while enabling the exchange of accurate and trustworthy information between all industry players.
IDMP comprises five different standards (see figure 1) that combined cover the entire product lifecycle: products in development, investigational products, products under evaluation and authorized products.
Figure 1: The five standards within ISO IDMP
IDMP standards are intended to support applications and processes where it is important to identify and track the use of medicinal products. They establish data definitions, dictionaries and concepts as well as describe data elements and their structural relationships. The standards cover the following aspects to describe a medicinal product:
|Medicinal product name||Ingredient substances|
|Pharmaceutical product (route of administration, strength)||Marketing authorization|
|Manufacturing||Clinical final authorization|
IDMP compliance means implementing the standards for how all data is captured, transformed, governed and reported. A brief look at all the data sources for a single authorized product gives an impression of the size and complexity of this task (see figure 2).
Figure 2: Data sources for an authorized product
It’s clear that there is no single data source for a product. It spans data from various business units, functional areas, and systems. Preparing for IDMP can’t be left to the IT or Compliance departments alone. An IDMP program is as much about people and process as it is technology.
IDMP: Threat or opportunity?
When the price of non-compliance can run into the millions of dollars or even having the product withdrawn from market, it’s imperative that companies are prepared to meet the EU’s revised timetable. It will take an enterprise-wide, cross-functional program based around data standardization, master data management, data quality and information governance. Companies need to identify exactly where all the data resides and establish how that data can be extracted and made compliant.
With hundreds or thousands of products, it becomes impossible to manage for IDMP using spreadsheets or existing Product Lifecycle Management (PLM) systems. This is especially true as so much of the required data is unstructured. Deloitte suggests that often more the 60% of all IDMP data attributes existing only in an unstructured format. The analyst firm further thinks that less than half of all IDPM data will be populated directly from source systems.
Similar to GDPR, IDMP compliance is based around a far greater control and governance of key data. If a company is able to identify, extract and cleanse data from wherever it resides in the organization, it can apply a master data strategy that would lead to lowering the cost and effort of meeting the requirements.
More than this, it opens up a range of benefits including:
- Increase visibility and control of product data across the entire organization
- Improve information flow across business functions and systems to improve efficiency and innovation
- Enable advanced analytics on trusted data sets to reduce risk, boost productivity and drive innovation
- Reduce costs associated with managing, maintaining and integrating data across functions and systems
- Improve information flows with regulators, partners, suppliers and customers
An enterprise approach to IDMP
IDMP is a very far reaching piece of legislation and it will require all parts of the organization to work together to reach compliance. DIA, the global not-for-profit organization dedicated to healthcare product development and lifecycle management suggests IDMP gives Life Sciences companies the opportunity to take an enterprise architecture (see figure 3).
Figure 3: IDMP at the center of an enterprise architecture
DIA defines enterprise architecture as ‘ the organizing logic for business processes and IT infrastructure reflecting the integration and standardization requirements of the company’s operating model’. It brings together strategy, process and technology to accommodate change both internally and externally.
The enterprise architecture vision of DIA closely resembles the capabilities of OpenText’s Enterprise Information Management solutions that enable companies to manage and control data, content, workflows and processes across the entire enterprise. You can gain control of your product information – both structured and unstructured – know how it’s stored and processed, and manage you its exchanged with other industry players.
It seems likely that most healthcare systems around the world will adopt the ISO IDMP standards. All Life Sciences need to be preparing for IDMP compliance. This takes time and effect to put in place the process and systems to manage the vast amount of data needed to meet all five standards.
If you’d like to know more about how OpenText can help you move towards IDMP compliance, please use the contact form on this page.