Current State of IDMP and the phased approach plan
On 25th of September the IRISS EU IDMP Task Force confirmed a phased IDMP implementation approach, while the official legislative date remains 1. July 2016. The European Commission has accepted the phased implementation approach as proposed to HMA in July as follows:
Preparation phase – Now until end of June 2016
Transition phase I – Product & Substance Pre-Submission – 1 July 2016 to 1Q 2017
Transition phase II – Product & Substance Submission – 1Q 2017 to 4Q 2017
Maintenance phase – Beyond 4Q 2017
It is expected that phase I requirement will include 92 data elements, but it’s not entirely clear exactly which 92 yet, as it has not been published. We expect a more formal statement from EMA before the end of 2015.
Important to consider is that latest by Q1 of 2017 all European Marketing Authorization Holder will be required to have completed the migration from xEVMPD to IDMP. From that date onwards only IDMP messages will be accepted.
Standard Terminology update / GInAS update and outlook
Related areas have made progress as well – especially the definition of standard terminologies and the supporting systems. Most notably on this side is the NIH GInAS workshop from 7th-8th September in Uppsala, Sweden. GInAS, comparable with EDQM, is currently the most prominent and advanced system for data capture and management by regulatory authorities that can be reused for IDMP purposes (quite clearly, IDMP is only one of the many uses a system flexible as GInAS can and undoubtedly will have).
GInAS is a combined effort of Health Canada and the FDA to streamline and standardise the storage, communication and definition of known substances within the pharmacovigilance domain. The system itself is currently under development and is available open source via the GInAS website. The site also hosts a publicly accessible demo installation with a large dataset for development and testing purposes. It is expected (though not officially communicated yet) that not only the FDA but also the EMA will make use of this system and manage IDMP-related substances within this database.
The provided demo installation suggests that GInAS can be configured to be quite open and could potentially allow external users and systems to access non-confidential data directly, allowing the industry and software to automatically query the underlying agency database for latest terms and updates and thus directly streamlining the communication path between agencies and the industry.
IDMP – More potential than “just” Pharmacovigilance
IDMP has the potential to not only transform the internal systems into the often-quoted “single source of truth”, but also provides more facts that the industry and the regulating bodies alike can benefit from. IDMP is also an opportunity to bring pharmacovigilance data and communication paths within the pharmacovigilance space into the age of “big data” with all related benefits.
If we are allowed to digress to a perfect world for a moment, imagine non-duplicated data entries via streamlined electronic portals to report pharmacovigilance data, submission metadata, standard terminologies, to avoid miscommunication and other submissions building on top of this, like ICSR’s, eCTD’s and other data that we currently have to submit in a very transactional and redundant way.
Even though there seems to be a lack of updates and information at the moment, IDMP task forces, whether being it the ISO implementation team, EMA or HMA are hard at work to get as many open questions answered as possible while also trying to reduce the initial effort spent by the industry.
More interesting though, as the example of the GInAS meeting update has shown, even the regulatory bodies do see benefits in open systems right now and this is the right time for the industry and the software vendors to express the need of modern, open and reliable systems for complex data models such as IDMP. The result has the potential to create systems that instead of increasing the workload of data reporting by the IDMP data model but to decrease the workload while improving the data quality.
Should you be interested in a conversation about IDMP or get advice on what to prepare for phase I, please contact us at email@example.com