In the run up to the Identification of Medicinal Products (IDMP) initiative’s implementation in the European Union, the European Medicines Agency (EMA) conducted a webinar to share their plans for SPOR data services. SPOR represents the four domains of master data to be regulated by IDMP – Substance, Product, Organization, and Referential. Fittingly, the EMA’s data services will be organized as four separate projects aligned to each of the four data domains.
The four data services projects will be phased in over a few years, supporting the same staggered approach of the IDMP roll-out. With more concrete details to be provided over the coming months, the first projects to go live will be Organizations Management Services (OMS) and Referentials Management Services (RMS). These projects will usher in the following 6 key changes:
Users will be able to access SPOR data in two ways. One will be directly through an EMA-provided SPOR web interface and the other will be through applications developed by companies using Application Programming Interfaces (APIs) provided by the agency. The EMA plans to provide final API specifications by the end of August.
Assistance will be provided by both an IT service desk and EMA data stewards. The IT service desk will be available for technical support. Data stewards, a specialized team of EMA staff, will manage data on behalf of stakeholders in addition to providing user support. They will also serve as a main point of contact for access requests to SPOR services, and change requests for new or updated terms.
When OMS goes live, a dictionary will become available containing organization information for Marketing Authorization Holders (MAHs), Marketing Authorization Applications (MAAs), and Maximum Residue Limit (MRL) veterinary applications. Sponsors will then need to map their local organization data against what is available in the dictionary to determine which data needs to be submitted or updated. The dictionary will be expanded and maintained through a pre-registration process requiring sponsors to request organization registration prior to sending regulatory submissions.
The RMS roll-out will be marked by the release of reference lists from various maintenance organizations (WHO, EDQM, MSSO, BfArM, etc.) This will include lists from the European Union Telematics Controlled Terms (EUTCT) system, lists to support OMS, and lists to support both ISO 11239 (pharmaceutical dose forms, units of presentation, routes of administration and packaging) and ISO 11240 (units of measurement). The EMA will act as a broker, providing and maintaining reference lists, while sponsors are tasked with mapping their local data against the terms provided. Sponsors will need to either align their data to the controlled terms or register any legacy or specific terms with the agency.
To aid in the upcoming transitions, the SPOR task force has been assembled to serve as an advisory group on aspects like planning, approach to implementation, and maintenance of standards. They will also aid in the cascade of communications to external stakeholders in the EU. A change network has also been constructed to broaden the reach of such communications through channels of industry change liaisons, National Competent Authorities (NCA) change liaisons, contact points within industry associations, and a Subject Matter Expert (SME) stakeholder office.
The focus for the remainder of 2016 will be the OMS and RMS implementation, slated for December. This will provide the foundation to support the delivery of PMS and SMS. Planning for PMS and SMS will resume toward the end of 2016. Implementation for iteration 1 of PMS and SMS is expected to take a full 18 months, a period that will be triggered by the release of implementation guides. After the implementation guides are released, there will be a 12 month transition period prior to a 6 month enforcement period. More concrete dates around these timelines are expected sometime this fall.
The only activity recommended for industry prior to OMS and RMS implementation is standardizing any free text package descriptions to align with terms provided in the containers list from EDQM, as this has been identified as a high risk area. The next steps will be mapping local data against the RMS lists and the OMS dictionary, once available this December. As mapping activities reveal data gaps or discrepancies within the lists or dictionary, sponsors can begin the pre-registration process of submitting requests for either Referential terms or Organizations data. Sponsors will then need to keep their data synchronized with OMS and RMS in an ongoing effort.
Industry engagement activities have been planned to help sponsors along the way. In late August, key reference materials will start becoming available on the SPOR public website. Business-related training will become available in late October, while systems-related training webinars will begin in December. A best practice broadcast is planned for January and February will bring online training videos.
A summary of the event can be found here, with slides available on the “documents” tab and a recording of the event on the “multimedia” tab.