In its latest announcement, European Medicines Agency (EMA) informed the Industry Change Liaisons that it has formally approved P&SMS Iteration 1 project covering Identification of Medicinal Products (IDMP) compatible authorized Human and Veterinary Products and Substances Management Services. This is in line with reinforcing the strategic importance of SPOR programme and implementation of a high-quality IDMP-compatible product database to support EU regulatory processes and various business cases.
As planned earlier, implementation process of the Products & Substances Management Services (P&SMS) will continue to be in a phased manner. The first phase is already funded but due to Brexit and the consequent EMA relocation, the process might have to face a six-month lag. Even when the granular details of the plan are still under discussion, it is decided that the project has been approved to continue beyond the March 2019 relocation and currently foresees an extension of the overall timelines.
The Story Behind
The EMA has been known to oversee implementation of IT solutions that support businesses in the EU member states, and pharmaceutical industry along with a broad stakeholder community that includes the public. The data duplication, reduced data quality and other inefficiencies led to the introduction of new ISO IDMP standards to ensure consistent documentation, coding and exchange of product information. The five new ISO IDMP standards are all about master data, which is any non-transactional information that is considered to play a key role in the core operation of a business and is re-used for multiple purposes.
Now, in the case of regulated EU Pharmaceutical industry, there are four domains of master data, collectively known as the SPOR data services.
- Substance Management Services (SMS)
- Product Management Services (PMS)
- Organization Management Services (OMS)
- Referential Management Services (RMS)
SPOR applies to both Human and Veterinary domains, and aims to support the implementation of the standards developed by the International Organization for Standardization (ISO) for the Identification of Medicinal Products (IDMP).
The first phase of implementation of SPOR through RMS and OMS has gone “live”, laying the foundations for PMS and SMS, and the subsequent enforcement will occur approximately six months later. Available in multiple languages for exchange of data between information systems and applications across the regulatory Network and the pharmaceutical industry, once formally enforced, this would mean that use of RMS & OMS is mandatory in any given Regulatory process.
What does it mean for the Pharmaceutical Industry It is time the industry is well-acquainted with the workings of Referential Management System (RMS) and Organization Management System (OMS) services. Right from getting first-hand experience of the concept and complexities to initial implementation and maintenance, to be prepared is the key.
It is also crucial to align the existing processes and systems with RMS and OMS. To look beyond the immediate line of visibility and brace for impact, keeping in mind the evolving guidelines and shifting timelines, one might need constant assistance of a IDMP industry expert. This would not only help them to carefully plan for a future-ready solution but also derive business benefits out it. It’s time to partner with the right Regulatory expert for Consulting, Operations & Technology Services, and seamless IDMP implementation for its clients.