How ready are you for IDMP?
IDMP (IDentification of Medicinal Products) is a set of international standards developed by ISO that will become mandatory in Europe in a phased approach, effective from 2018, and will also be adopted by the FDA and globally over the next few years. As with any new regulatory change, it is valuable to hear about others' experiences and ideally understand and learn from industry best practice.
Joining the IRISS Forum is the best way of keeping track of IDMP. I joined IRISS this year - it is an excellent source for up-to-date IDMP information and also valuable input from industry experts (such as Andrew Marr, Vada Perkins, and others).
The IRISS (Implementation of Regulatory Information Submission Standards) Forum was created to address the need for a single central forum for open and broad stakeholder discussion of evolving standards, user requirements and practical, global implementation issues of these standards for the mutual benefit of both industry, government agencies and ultimately, public health.
IRISS recently (September 2016) surveyed its members, both pharmaceutical and vendor, across the current state of readiness around IDMP compliance. The companies that took part in the industry survey covered a wide range of organizational sizes, from small companies those with less than 100 EU authorizations to larger ones with more than 5000 (or, less than 10 active ingredients to more than 250). Over 80% of those in the survey had a global reach.
What did the survey say about company readiness for IDMP?
Generally there was a good knowledge of the IDMP standards, however less was known about the implementation plan. For at least half of the companies, management are generally aware and committed; however 30% of companies reported that their management were aware of IDMP but did not understand the implications yet.
Although implementation details and timelines are not fully clear, there were only two companies whose IDMP projects were on-hold, either due to the uncertainty or other reasons (such as product portfolio change).
Nearly 80% of respondents said their organization already has an active IDMP project, and many of these are looking at IDMP as a lever for internal improvement around information management and internal data management.
Generally, IDMP projects were being led by Regulatory Affairs or Regulatory Operations, but the range of departments involved was impressively broad, including CMC Regulatory, Labelling, Pharmacovigilance, Regulatory IT, R&D IT, Product Supply, Clinical Development. This really demonstrates the reach of IDMP within a company and the impact these new standards will have across the business.
What action are companies taking, around IDMP?
There was a wide range of activities being undertaken currently in IDMP projects, with over 80% engaged in gap analysis, and around 70% busy with data inventory, data quality assessment. These are critical steps to establish what any individual company needs to do, to make the step from xEVMPD to IDMP.
While this shows evidence of plenty of activity around IDMP, external factors are also contributing to some projects not moving ahead as fast as initially planned. Many reasons were given for this, with the main issue being lack of clarity:
- Unclear guidances, standards
- Lack of clarity on scope, data requirements, who needs to be involved, impact
- Lack of firm, clear, believable timelines from EMA
Communication and Clarity
The survey asked respondents to describe the types of communications they felt they needed from the EMA or National Competent Authorities. Obviously, following the previous concerns (above), the top set of requests were around final implementation guides and timelines, with specific requests around details for both Iteration 1 and beyond. Indeed, the results of the survey have been shared with the communications team at EMA.
There was a huge spread of ideas how best the EMA/NCAs could provide this information – website improvements to assist planning and record decisions, tools for information exchange, webinars, training, and more. The pharma respondents also wanted more updates and sharing of best practice from their Trade Associations; and specific clear product roadmaps, implementation implications, and realistic delivery statements from vendors.
On the technological approaches, most companies (~70%) are planning to use a Gateway approach for IDMP submission, with around 10% planning to use the EV-Web replacement, and 20% undecided; and this will be a change in technical approach compared to xEVMPD for 70% of the pharma respondents. Most companies will not use RIM as their IDMP database, but will use an IDMP hub, involving some level of Master Data Management – however the scope of MDM involvement was very varied.
Several companies intend to use structured content authoring, across SmPCs and labelling documents in particular, as part of their IDMP solution. Many have decided to use semi-automated extraction (across SmPCs, labelling documents, CMC modules, eCTDs, and others), and a significant proportion (40%) are undecided about this approach.
Funding for IDMP Compliance
Funding for IDMP projects generally is coming from Corporate (~40%). IT (21%) and Regulatory (17%), and there is a wide range of spend predicted across all the companies, both over the next 12 months and the next three years – from less than €2.0M to more than €7.5M.
Critical Business and Technical Issues
The final part of the survey asked for the top 5 business issues, and the top 5 technology issues, that companies see in complying with IDMP. As can be imagined, the range of responses for both was broad. For the top 5 business issues, the scope and degree of business process change, finding and maintaining resources, lack of clear EU guidance, and data sources, data quality, and data maintenance came out top. For the top 5 technology issues, data source and data system connectivity was key for over 55% of respondents. Also high on the technical challenges were changes in the timelines, lack of robust technical solutions, and the need for tools for extracting and managing data from unstructured sources.
Overall, the survey suggested that, at least for IRISS members, there is a good degree of awareness and preparation for IDMP, which is heartening; however there are still plenty of challenges ahead.
Update 10th October 2016: Industry and Vendor surveys now publically available on IRISS forum website.