On the 20th of June 2017, EMA provided new information to the Industry Change Liaisons as a part of their information cascade.
EMA has formally approved the P&SMS Iteration 1 project covering IDMP compatible authorized Human and Veterinary Products and Substances Management Services and it is underway.
Together with the EU Network, they reinforced the strategic importance of the SPOR programme and the implementation of a high-quality IDMP-compatible product database to support EU regulatory processes and various business cases.
The implementation process of P&SMS will continue to be phased. A first phase is funded, but due to the Brexit and the EMA relocation there will be a minimum of a 6-month interruption.
While details on the plan (duration and sequence of tasks) are still under discussion with NCAs and Industry, the project has been approved to continue beyond the March 2019 relocation and currently foresees an extension of the overall timelines.
These facts were taken into account:
- There is a learning curve due to former RMS and OMS projects
- Delivery method of the P&SMS project to engage the stakeholders,
Milestones communicated in the past are no longer applicable:
- Publication of the EU Implementation Guides (EU IGs) in 2018
- Industry will be requested to start submitting the product data in a new format in 2019
The P&SMS project is currently under re-planning.
The tendency remains that Product submissions, in the new format, will become mandatory in the EU, while the SPOR Task Force is still in discussion.
On 23 March EMA held a webinar with Change Liaisons on the intended use of SPOR in Regulatory Processes. This went into more detail than had previously been provided. With respect to nearer term impacts, both RMS and OMS are expected to go ‘live’ around the end of Q2 2017 with subsequent enforcement occurring approximately 6 months later.
RMS and OMS data will be available in multiple languages for the ongoing exchange of data between information systems and applications across the regulatory Network and the pharmaceutical industry. RMS implements ISO 11239 and 11240 standards and provides Lists and Terms of Referentials while the OMS dictionary delivers list of organisations with associated physical locations to support EMA and EU-wide regulatory activities.
The importance of the RMS & OMS 1st enforcement means that the use of RMS & OMS has become mandatory in a given Regulatory process. From RMS & OMS go-live to RMS & OMS 1st enforcement there is normally a period which is not less than 6 months. Some changes in the current submission processes are being explored and it is likely the first mandatory use of RMS and OMS is implemented in 2017.
It is expected that the Art.57 (As-is), xEVMPD (IMP) (As-is), and the eAF regulatory processes are integrated with RMS & OMS around the same time. At that stage data is entered once and re-used across Pharmacovigilance and MA processes. Eventually, RMS & OMS will become mandatory in other business processes (e.g. when MA applications are created via CESSP or CT applications through the new CT portal).
What Can You Be Doing Now?
Industry should be preparing to become familiar with the RMS and OMS services.
For RMS, you can:
- View, search, export Referentials Lists and Terms
- Request new/updated Referentials Lists and Terms
- Registration of provisional terms and brokerage of requests to other List Owners
- Translate Referentials Terms
- Subscribe to notifications of new/updated Lists
- Tag Terms to create relevant subsets
And for OMS, you can:
- View, search, export Organisation data such as names and address details
- Request new/updated Organisation data
- Review multi-lingual Organisation data