In the current age of big data, the pharmaceutical industry is still very document driven. The transition from paper-based documents to digital data operations is challenging and requires time. Furthermore, in pharma, not everyone speaks the same language. When considering the definition of a product, a pharmacist might refer to different formulations while a controller would refer to marketed products and the master data manager will refer to stock keeping units. This simple example of what varying definitions of a product is demonstrates a lack of standardization and common terminology.
The Identification of Medicinal Products (IDMP) is a set of five ISO (International Standards Organisation) standards that clearly define all aspects of a medicinal product authorized for either a clinical trial (as an investigational medicinal product) or for the market in general (as an authorised medicinal product). These standards refer to: medicinal product information (ISO 11615); pharmaceutical product information (ISO 11616); substance information (ISO 11238); and controlled vocabularies describing units of presentation, routes of administration and packaging (ISO 11239) and units of measurement (ISO 11240) (see below).
IDMP will allow for the unique identification of a medicinal product through the generation of unique identifiers at the medicinal product level (MPID); the pharmaceutical product level (PhPID); the packaged medicinal product level (PCID); the manufactured batches level (BAID); and the substance and specified substance level (SSID). These IDs will be used in communication to the regulatory authorities, but most importantly, they can be used within your organization allowing good data management and good data quality.
The introduction of IDMP is especially important for patients and health care providers in the use of personalized medicines as the unique identification of products and their key characteristics will increase overall transparency. For health authorities and marketing authorization holders, implementation of IDMP will lead to efficiency gains, an overall simplification through data exchange, and an increase in the harmonization of product information, interoperability and data quality.
Authorities around the world are looking at IDMP for standardization and concrete implementation has started at the European level by the European Medicines Agency (EMA) with the publication of the European Union (EU) regulation No. 520/2012 in 2012. The U.S. Food and Drug Administration (FDA) and Health Canada have recently also indicated that they are looking into an incremental approach to IDMP as the standard to help create global harmonisation.
The EMA has chosen an implementation of four domains of master data management for IDMP information. These will collect data for substances (SMS), products (PMS), organizations (OMS) and references or lists of controlled vocabularies that describe products attributes (RMS). Through substance, product, organization and referentials (SPOR), the EMA will apply the full IDMP data standard through a sequenced approach. Iteration 1 focusses on a small subset of data fields that will allow the creation of MPIDs, PCIDs and SSIDs.
The FDA, on the other hand, started a structured data program as early as 2005, with the release of Structured Product Labelling (SPL) guidelines. These guidelines have been updated over the years and releases 6 and 7 have potential for IDMP alignment. Further evidence of data standardization by the FDA include:
Furthermore, both the FDA and EMA are looking to implement further initiatives supporting a harmonized IDMP implementation, with the FDA currently mapping pharmaceutical quality/chemistry, manufacturing and controls (PQ/CMC) to the IDMP standard and the EMA implementing the use of OMS and RMS in the electronic application form (eAF). Other initiatives in Europe include:
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In Europe, the timelines and plans for implementation of IDMP have been anything but straightforward, partly due to the relocation of the EMA to Amsterdam following the Brexit vote in June 2016. This makes IDMP implementation projects across industry a difficult sell internally. However, since 2012 there has been an increased involvement of industry, authorities, vendors and interest groups promoting the use of IDMP. Furthermore, there has been an increase in commercially available solutions based on IDMP and a crucial shift in industry awareness on the role of structured product data and the benefits that can come from good master data management for product information.
In moving forward with IDMP projects, it is important to consider that companies that want to benefit from structured product information will need to address quality in data, systems and processes in line with these standards. Despite the progress, there are still several challenges ahead to be overcome. This is mostly due to:
To address these challenges, projects should considerer IDMP for what it is - a data standard - that, with good master data management, can provide great internal benefits. With this perspective, companies will profit from efficiencies through standardization, automation and interoperability as well as improved quality management and data exchangeability.
In practical terms, there needs to be a stepwise approach that views structured product information as an asset. The first step is addressing the transition from local documents to structured product information. It requires the examination of the real value of structured product information addressing stakeholders’ perspectives while optimizing organizational, procedural, technological and informational requirements. Once this is concluded, it will be possible to align data exchange between systems, functions and processes. All projects should be cross departmental/cross-functional, which will lead to efficiency gains that address internal customer needs.
Looking beyond, it will also be possible to improve efficiencies and harmonization through the exchange of data between organisations and across the company. This is particularly important for big pharma companies where data harmonization and governance may vary between departments, divisions and countries. This can be best seen through an example: a packaging information rationalization project in which you would firstly apply package registration and package data standardization, followed by enterprise resource planning - regulatory information management system (ERP-RIMS) alignment, to communicate internally and externally on Europe’s Falsified Medicines Directive (FMD) and with the European Medicines Verification Organisation (EMVO) to achieve global proactive identification of counterfeited products, which benefits companies from direct data exchange with packaging contract manufacturing organizations (CMOs).
Altogether, it is important to recognize that IDMP is a set of data standards that given its association with the EU regulation, has been seen mostly as a compliance-driven project, but that in fact should also be considered beyond compliance enhancement as a method to improve an organization’s internal processes. By building company-specific, value-driven roadmaps with IDMP as a data standard with structured product information as a key business asset, it will not only improve data quality and internal efficiencies and stretch limited resources further, but in time, it will achieve global interoperability.
Frits Stulp is the managing director of Iperion Life Sciences Consultancy, a Service and Referral Partner of MasterControl. With over 18 years of experience in the life sciences industry, he has worked on multiple regulatory compliance projects, becoming an IDMP SME program manager and adviser to several high-profile pharmaceutical companies, regulatory authorities and pharmacovigilance software suppliers.
Stulp is currently the project manager for the European Union’s (EU) Substance Registration System (MEB/EMA); is an active member of the EMA ISO IDMP Task Force for Substances and Products; and is the IRISS Forum IDMP topic lead.
Having previously worked for Yamanouchi/Astellas and Accenture, Stulp in 2011 started his own company, Mesa Arch Consulting, where he is currently an independent project manager and adviser. He holds a master’s of science degree in pharmacochemistry from the Free University of Amsterdam.