The submission of data regarding human medicinal products in the European Union has been a requirement since July 2012 when it became mandatory to supply information to the Extended Eudravigilance Medicinal Product Dictionary (XEVMPD) of the European Medicines Agency (EMA).
Was it a challenge for you to collect, store, check quality, process and submit the required data within the defined timelines?
This led to many technical and process issues, which, in turn, have led to significant issues with the quality of the data held by the EMA. Overall, the quality is considered to be less than adequate to use for the intended purposes of support for pharmacovigilance activities. In addition, there are many issues with the Controlled Vocabularies utilised and further expanded during data collection, particularly for Substances and Organisations (MAHs). These are in the process of being addressed but it will mean significant rework will be required.
Lessons need to be learned from the issues of XEVMPD. Racing against deadlines with ill-defined guidance and poorly defined and controlled vocabularies has to be avoided and so to avoid a similar painful experience when IDMP is implemented, early assessment and planning is recommended.
What steps have you taken so far?
MAHs have an opportunity to prepare and consider a better way to manage medicinal product information within their organisation. IDMP will require data from a much wider set of functions with a pharmaceutical company and so Regulatory Information Management systems will needs to have a wider reach and/or sourcing of data.
Getting to grips with IDMP will be a significant challenge and there will be many ways to address the needs of IDMP. The assessment of the impact of IDMP within a company and the challenges and opportunities that it will bring should be initiated as soon as possible. To delay will compress the timelines to prepare for the July 2016 implementation date and offer less opportunity to implement solutions and processes that will be efficient.
Join Andrew Marr, an active member of the ISO Committee and Sinisa Belina from INFOTEHNA on 4th December where they will be addressing the challenges and opportunities in transition from XEVMPD to ISO IDMP. Register here.