The many storylines about the Identification of Medicinal Products

in Advisory, 14.04.2016

The life science industry moves towards implementation of Identification of Medicinal Products (IDMP). However, the storylines about IDMP and the agenda of Drug Information Association (DIA) congresses are variegated.

Transition to an industry-wide naming convention, transformation from a document-centric organization to an information-centric organization and transition of existing data management strategies to new IDMP processes. The many storylines are multiform and dynamic and so are the requirements that apply to IDMP. Depending on your governance structure, your business operations and your systems & tools, the data may be caught by a set of regulatory rules you have to consider in order not to let regulation stop your business.

What and who drives the new regulations for the life science industry?

The life science industry is faced with upcoming regulations of submitting data in accordance to ISO Identification of IDMP to be introduced at the end of Q4 2017, following shortly with Unique Device Identification (UDI) standards to be introduced 2018 and 2020 respectively.
The new upcoming regulations in the life science industry are a result of the need to improve drug compliance and control of generic prices. In order to improve the substances, products, organizations and referential (SPOR) data on a global basis, an improved master data service is required, which allows a greater extent of data quality.
The roadmap to implement IDMP standards is given by the European Medicine Agency. The requirements are not fully specified yet, but it is high priority to increase data transparency along the life cycle of a product and to ensure safety and security for patients. Therefore the idea is to send the data for the first submission[1] planned already at the end of Q4 2016. As a consequence the life science industry is facing a significant challenge in preparing and maintaining data of Extended Eudravigilance Medicinal Product Dictionary (XEVMPD[2]) including the switch to IDMP.

What are the main consequences of IDMP?

Due to the short timeframe until the first data submission, which often comes along with a heterogeneous system landscape and decentralized master data, the importance of consistent and transparent master data becomes even more crucial. Challenges for most companies in terms of IDMP data undoubtedly will be:

  • Does our company have the ability to locate an appropriate source for processing data out of different systems like ERP, CRM, SRM in an acceptable time and usability manner?
  • Does our company have the ability to ensure that the data aligns with the granularity, vocabularies, and data types of IDMP?
  • Does our company have the ability to establish a mechanism/methodology (e.g. impact on governance, processes, content & quality, systems & tooling) to maintain and ensure consistency of the data to be submitted?
  • Does our company have the ability to identify and gather data which is reflected during pharmacovigliance?
  • Does our company have the ability to contribute in data aggregation, consolidation and harmonization with respect meeting quality standards?

What are the smart investigations of implementing IDMP/UDI standards?

The first and biggest impacted area by IDPM is master data management, in which EMA has created numerous investigations to develop an implementation roadmap. Further, smart investigations will include: complaints- & non-conformities methodology to monitor IDMP standards and an end-to-end traceability service in supply chain to initiate UDI standards.

  • Master data management methodology
    Master data management consists of four pillars: Governance, processes, content & quality and systems & tooling. In order to realize master data management, all four pillars should receive joint attention. By implementing and monitoring master data as a strategic, integrated and holistic approach, it ensures high quality of master data and enables to manage, improve and determine whether the compliance requirements are met.
  • Complaints- & non-conformities methodology
    Key objective is to implement a process for tracing all complaints related to certain products in real-time as well as to identify non-conformities as data gets centrally located in a fast database (InMemory technology). Such a database basically provides the necessary speed to analyze the data and relies on main memory for computer data storage. The complaints- & non-conformities methodology is seeing the most profound transformation from IDMP standards.
  • End-to-end traceability service in supply chain
    Last but not least, the end-to-end traceability service in supply chain has the potential to be a true science, enhanced by data and software. Examining technologies for identifying unique items can be achieved through telematics and RFID technology. The ability to link a track and trace compliance approach, enables life science companies to plan the demand on a precisely basis.

Outlook: What are the added values of IDMP standards, triggered with smarter investigations?

  • Improvement of data compliance and a strong position towards country-specific medicine agencies
  • Reduced risk of adverse audit findings (e.g. non-compliance with terms and conditions on grant), as a result avoidance of potential sanctions (e.g. product recalls) from the regulators through accurate and timely implementation
  • Optimization of master data through the lifecycle of a product resulting in the avoidance of redundancies
  • Efficient and effective assessment of master data quality, including an extensive set of analysis rules
  • Prime example for master data management with respect to industrialization 4.0

Conclusion/Recommendation

The need of establishing a single source that is aligned with ISO standards has become even more important for the life science industry due to the new upcoming regulations and challenges by medicines agencies. It should be stressed that IDMP/UDI regulations are still in the early implementation stages for many life science companies. Requirement definitions and concepts will continue to evolve, as new upcoming regulations come to fruition within the industry and towards patient safety. The storyline of IDMP is indeed dynamic, but from an objective point of view it could also be considered as simple: it is about the smart investigations of methodologies and services.

 
[1] First data submission includes CVs (ISO controlled vocabularies; controlled terminologies; dictionaries) required for ISO11238 (ISO substances standard) /11615 (ISO Pharmaceutical product information standard) include 1&2 iterations – CVs used in EU or adopted from other region + new global CVs. Migration and Consolidation of EUTCT (European Union Telematics Controlled Terms)
[2] XEVMPD defines controlled vocabulary to be used for the marketing authorization of medicinal product

 

Further information:

 


1 Comment

  1. Marlene Dobretsberger

    Great insights regarding the new upcoming regulations. Would be interesting to know more about the role(s), skills and capabilities, which should be considered regarding the switch to IDMP and UDI implementations for life-science industry. There is also a trend from risk-/benefit assesment to risk-/benefit identification at the beginning of the product life-cycle, which has a positve impact on the complaints & non-conformities methodology. Therefore very interesting. Many thanks!

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