The Ambition of IDMP is Ultimate Patient Safety. IDMP stands for IDentification of Medicinal Products
and is a new worldwide standard. IDMP is different from xEVMPD (xEVMPD
= extended EudraVigilance Medicinal Product Dictionary: a
pharmacovigilance initiative at the European level. IDMP takes a quantum
leap beyond xEVMPD, as it goes into much more detail (hundreds of
fields) about product information), as IDMP is a global standard while xEVMPD is European only. IDMP requires life sciences companies to provide the next level of transparency for specific medicinal products delivered to specific patients through complete, multilevel identification.
Europe is already mandating its use by mid-2016 and other
regions are expected to follow. IDMP is defined by five standards
created by the International Organization for Standardization (ISO):
ISO 11615, ISO 11616, ISO 11238, ISO 11239, ISO 11240. ISO 11615 and
11616 define and differentiate "medicinal products" and "pharmaceutical
products" which have "MPID" and "PhPID" numbers. ISO 11238 defines
substances. ISO 11239 and 11240 define controlled vocabularies for
pharmaceutical dose forms, units of presentation, routes of
administration, packaging, and units of measurement. The ISO and ICH
regions are currently developing Implementation Guides which will
further define the details. The ISO standards are compatible with the
US HL7 (Health Level Seven) standard.
Implementing IDMP involves regulatory affairs, safety, clinical development, and others:
- The product data will usually have to be sourced from many departments, transformed and cleaned, collated in a company product repository, and have any data gaps filled via data entry
- The central repository will have to be maintained using change control
- The repository data will be sent to regional/worldwide IDMP dictionary maintenance orgs
- Safety and clinical applications will consume the regional/worldwide IDMP dictionaries
This means that a 360° understanding of the investigational and
authorized medicinal products delivered to patients in specific markets
will allow health authorities, such as the European Medicines Agency (EMA), to take preventive and corrective actions that ensure patient safety.
Full disclosure means for Patients that they can get answers to questions such as:
- Where did you manufacture my drug?
- Where did you package my drug?
- Which qualified sources have you used?
- Where was the packaging printed?
- Which controls have you executed?
- Which formulation has been used?
- Did you have the approval to ship this product?
- What is the expiration date?
Full Disclosure means for Life Sciences Companies
that they need to find a new way of managing the massive and consistent
data set owned by multiple departments within their organization, with
hundreds of fields defined in the data model.
There is currently uncertainty as to what aspects of IDMP will
become mandatory in Europe on July 1st 2016. The European Medicines
Agency (EMA) has announced in February 2015 that it is putting together
a task force to oversee the implementation of new standards for
identifying drugs and to develop a roadmap for EU-wide implementation of
IDMP standards. However, our understanding is that:
- Marketing Authorization Holders (MAHs) will have to submit
product information reports with IDMP data to EMA for new applications
- When submitting an E2B(R3) report to EMA, MAHs will have to
include IDMP information if it exists for any of the products in the
ICSR (Individual Case Study Report (ICSR) is an adverse event report for an individual patient)
- MAHs will have to be able to receive E2B(R3) reports from EMA that include IDMP information
IDMP should be seen as an opportunity for Life Sciences
companies to progressively transform the way they operate towards
cross-functional transparency for products. The early adoption
of a comprehensive change control platform, combined with other
Enterprise Applications, Data Sources integration and Analytics,
provides the opportunity to get enhanced safety signal detection,
enhanced product quality, to detect issues before the authorities, and
implement a holistic benefit-risk management.
Developing IDMP Implementation Strategy steps should
consist of a reduction of Manual Data Collection and Entry, proper Data
Source Integration to achieve a single source of truth for Product
Information, up to Cross-Functional Integration of People, Data, and
Processes in a Change Control Platform.
But there are challenges! Effective collection of
Medicinal Product Data requires the creation of a comprehensive
Medicinal Product Repository from various sources, to be developed
incl. Regulatory, Commercial, Safety departments: for this, a Data
Transformation is required. The Collection must be maintained
consistently over time: Controlled, automatic Updates to Medicinal
Product Repository must be executed when changes occur. Medicinal
Product Data must be propagated appropriately. It is necessary to
synchronize various business applications with the Medicinal Product
data. Finally, companies need to ensure communication with HA Gateway,
to generate and send IDMP product messages, and provide audit trails of
The Oracle IDMP Enterprise Foundation Suite provides all required capabilities to enable a Closed-Loop Risk Management, in which a Life Science company can:
- Receive & Code Adverse Events with IDMP (Adverse events are
coded against specific products using Medicinal Product Information for
Drug Dictionaries (MPID) and Pharmaceutical Product Identifiers
- Detect & Manage Signals (Signals are detected, prioritized, and analyzed to decide if they are true risks)
- Create Risk Minimization Plan (Risks are mapped to the IDMP data model and fed into dashboards for visualization)
- Create Risk Minimization Plan (A risk mitigation/minimization
plan is created in order to document the corrective & preventive
- Create Change (A change is initiated to fix the problem (add contra-indications, warning to leaflet)
- Submit IDMP Product Report (Upon change authorization, IDMP product message is prepared and sent to the Health Authority)
The solution covers Enterprise Applications & Data Sources
integrations (for example to CMC/Quality, ERP, RIMS, labeling, etc. and
Other Enterprise Services such as LDAP, SSO, SMTP, etc), Middleware
(with Data Transformation Services and Gateway Services), Applications
(With Oracle Agile PLM for Change Control Excellence, Oracle Thesaurus
Management System, and Oracle Argus for pharmacovigilance), and
Analytics (with Oracle Product Lifecycle Analytics - OPLA, Argus Analytics, Clinical Development Analytics, etc.).
We have developed a 10 questions survey which will help us understand
your specific approach to IDMP. We value your time and will therefore share with you the survey results (anonymized) once we get enough responses to have a meaningful picture. Thanks in advance for your participation!