Panacea embraces its responsibility, on behalf of clients, to keep abreast of changes in legislation and guidelines. Currently, one of the most notable changes is the impending implementation of ISO IDMP. IDMP was created to enhance and standardise pharmacovigilance activities and for us, it is natural to be at the forefront of this project. The project and its objectives have evolved with time, to such an extent that IDMP will now impact the entire lifecycle of the medicinal products (human and veterinary) once fully operational.
Whilst ISO IDMP is still a few years away from its complete implementation, Panacea is using our current PV and XEVMPD knowledge to stay ahead of the curve. We can see that this project will improve the protection of public health in the EU and hope you will find this update useful for this important step in our industry.
The EMA has decided on a Master data approach for the ISO IDMP called SPOR (Substance, Product, Organisation and Referential). The main goal of SPOR is to have everything (from clinical trials to the application forms and the CESP portal) integrated with this huge database. However, the full implementation will take some time to happen.
A staggered approach will be taken by the EMA with some elements being released sooner (as early as December 2016) and others much later on. The idea behind this is to learn from each step and provide a chance to industry to get used to this new system slowly. The integration with other services (such as application forms and submission portals) will also happen gradually.
A new database will be created with the SPOR data, but the data currently held in XEVMPD will be used to populate this, so, in theory, it will not be necessary to re-insert data already submitted via the XEVPD system. However MAHs will need to check this data and updated it as necessary.
The Referential management service (e.g. dosage, pharmaceutical forms, country codes, package codes, weight codes) and the organisation’s management services (data, providing the contact details of organisations and individuals responsible for various aspects of a medicines – which will include QPPVs) will be the first to be released. Once these services are in place, stakeholders should start preparations to replace their current data submission format, the eXtended EudraVigilance Product Report Message (XEVPRM) format, with the HL7 SPL format based on the ISO IDMP standards, ISO IDMP technical specifications and HL7 Common Product Model.
Precisely how this transition is going to be done and what is involved with the HL7 SPL format, should become clearer on the next few months when guidance documents, best practice and some training sessions from the EMA will be available. However, it is important to say that process changes do not start immediately at go-live.
For now, the only preparation needed is for companies to identify their master data and to tidy it up as much as possible in-line with the ISO standard terms already published (for example standardising how pharmaceutical form, different container closure systems, etc. are represented) .
Once the data is published in December, MAHs will need to check the published data and notify the EMA of any changes required.
The EMA has also introduced the ‘industry liaisons’ which are organisations such the AESGP (Association of the European Self-Medication Industry) or the EFPIA (European Federation of Pharmaceutical Industries and Associations) which are involved with the EMA SPOR task force. Unfortunately, there is not an organisation specifically for Generics yet, but it was hinted in by the EMA that this would come soon. Any questions on the SPOR approach and implementation can be raised with these organisations.
If you would like to discuss your implementation strategy for the upcoming ISO IDMP/SPOR processes in more detail, please contact Clarisse Ceotto on +44 1624 672777 or Clarisse.firstname.lastname@example.org.