xEVMPD and IDMP latest information
EMA is finalising its ISO IDMP implementation plans. Following the EMA’s IDMP Information Day on 23rd June read our blog on why we think it’s finally achievable – and a long way from the old xEVMPD approach.
EMA is part way through its QC process and making lots of changes to MA Holders’ xEVMPD data. This is causing many MA Holders serious concerns, as EMA is not providing details of what has been changed and data in their in-house systems need to be updated to match the EMA changes. To help with this, Samarind is providing its xEVPRM Comparison Tool to affected MA Holders completely free of charge. For more information please see our news item entitled Samarind’s XEVPRM Comparison Tool or email [email protected].
31st December was the deadline for all MAHs to resubmit their xEVMPD data. Any who could not meet the deadline should have informed the EMA and given a timetable to completion, ideally by the end of February 2015, as this information is needed for the new PV fee calculations and PSURs.
The first few of the eagerly-awaited ISO IDMP Implementation Guides have been released! Members of the IRISS IDMP group can find them in the IRISS website, and comments are to be submitted by Friday 19th December 2014.
Updates to our ‘On Demand’ application were released on schedule at the end of September.
On the subject of IDMP, EMA are due to be starting work on their Implementation Guide this month. There is some scepticism regarding whether there will be time for everything to be completed by July 2016 – we’re keeping up to date via the IRISS IDMP group and our various professional contacts.
EMA released their new Production system on 16th June, and the test environment (XCOMP) a few days later. This enabled us to complete our validation of Samarind RMS for Windows, and our new release was finalised on 30th June 2014.
Samarind’s updates of our new Windows release are largely completed, however we can’t finish our validation until the EMA provide us with a system to test with!
This month has seen updates to the controlled vocabularies (CVs), including remapping of dosage forms and admin routes to remove the entries that EMA have decided are incorrect or duplicates, updates to the technical documents and finally the Quality Control Methodology and the new schema. At the end of April the EMA also published its updated substances CV, along with guidance explaining the work done and how to request new substances to be added (request via email) and giving the mapping between ‘discontinued’ substances and what they should be remapped to.
February and March 2014
A flurry of updates to the maintenance guidance came out this month, including some corrections to the January documents and an updated FAQs document. Our specification for the updates to Samarind RMS is now complete and development is underway.
For our views on the changes see Miranda’s [blog articles].
31st January 2014
Finally EMA published their XEVMPD maintenance. Highlights:
- Only new authorisations need to be notified in 15 days. Changes are to be submitted within 30 days.
- All updates are to be done via the ‘Update’ operation type. ‘Variation’ is not to be used.
- The expected schema changes have been finalised – 5 new fields, one repeatable.
See our blog for more information.
Wednesday 18 December 2013
Yesterday EMA announced their final proposal for xEVMPD maintenance, inviting feedback by 10th January.
- ALL changes to marketing authorisations are to be made in 15 days.
- ALL changes are to use the ‘light’ process, by which they mean changes are to be notified using the ‘Update’ operation type rather than ‘Variation’.
- There are 5 changes to the xEVPRM schema.
The 15 days is a surprise – industry will probably push back on this. However being able to submit everything as an ‘Update’ will considerably simplify the process, as the type of and reason for each change will no longer need to be tracked.
The good news for Samarind RMS users is that updates within 15 days are already fully supported. However the 15 days will cause problems for those outsourcing their EVMPD submissions and could also be a problem for those using EVWEB due to the extra manual effort involved.
Tuesday 29 October 2013
In the Article 57(2) Implementation Group meeting last week the EMA outlined their timelines for the update and maintenance of the xEVMPD data. The key points are as follows:-
- Maintenance guidance should be available by January 2014
- Between June and November 2014 (the ‘transition phase’) MAHs should submit revised product records to bring their data up to date in line with revised guidance and quality standards.
- Maintenance will go live no later than December 2014.
- EMA will use the data to support their pharmacovigilance (PV) processes from January 2015 (possibly including fee calculations).
Substances and other CVs
EMA staff are progressing well with cleaning data in the substance, organisation, dose form and admin route controlled vocabularies (CVs). The substance data is expected to reduce from ~110,000 records to ~33,000 records as the ‘master’ substances are identified and the remainder are flagged as synonyms. A similar process is happening with the dose form and admin route vocabularies. This work is currently being done ‘off line’ so that existing operations are not affected until the process is complete.
Once complete, EMA will re-map and update existing EVMPD data to the cleansed CVs and publish the re-mapping information so that MAHs can update their internal systems with the corrected EV Codes.
Samarind will be providing its customers with update scripts that will completely automate this change.
There is no doubt that the quality of much of the data currently in the xEVMPD is poor. EMA would like to work with the Implementation Group to improve the guidance and agree a quality control methodology that can be built into the overall MAH submission process. The proposal from the IRISS IDMP Validation team (of which Samarind’s Software Director, Miranda Pothiawala, is a member) is also being considered.
One further new requirement from the EMA is that product data be held at the presentation level. However this is not yet agreed and will be discussed at the next meeting.
The transition phase
During the transition phase, from June to November 2014, MAHs are expected to bring all previously submitted data up-to-date and correct any errors. This is to be done as a single update; the details of individual variations, renewals and other regulatory activities that happened since July 2012 are not required.
Note that details of new authorisations should continue to be submitted throughout, within the existing 15 days time frame.
After the data has been corrected, from December 2014, product data must be kept up-to-date in line with regulatory activities. There are expected to be 2 different timescales depending on the impact of the change; expedited submissions, which should be submitted within 30 days, covering most types of activity and routine submissions, which will probably need to be submitted within 12 months.
EMA is also working on methods of handling transfers of ownership and renewals when this results in a change of MA number. Proposals have been made and details are expected in the January 2014 guidance.
Impact for MAHs
MAHs that used EVWEB to submit their data will need to decide whether they want to use EVWEB for resubmission and maintenance or move ahead with adopting a system such as Samarind RMS, which is the leading xEVMPD database system.
Other MAHs will need to work with their software vendors/IT providers to ensure that they plan for adoption of new versions of software to meet the required timescales. Samarind will commence updating its system as soon as the January guidance is published and xEVMPD maintenance will be fully supported in our Q2 2014 release.
How to move away from EVWEB
Samarind has developed an automated tool for importing xEVPRM messages files and associated SmPCs and acknowledgement files into Samarind RMS. This enables EVWEB users to simply update their existing data using Samarind RMS’s intuitive, easy-to-use interface and resubmit it quickly and easily prior to moving into the maintenance phase. For more information please contact us today.
And what about IDMP?
With the data quality issues and the xEVMPD maintenance having been delayed, the timelines for implementing IDMP by July 2016 are very tight. Following the ISO Technical Committee Meeting 215 in Sydney, it looks possible that the full set of implementation guides may not be published until mid/late 2015. This leaves little time for EMA to publish the EU specific guidance and get systems and processes in place ready for July 2016. We will know more after the May 2014 ISO meeting.