IDMP Knowledge Database

We have collected Cunesoft’s preferred list of IDMP related articles

IDMP Phases as per September 2015: 

The European Commission has accepted a phased implementation approach as proposed to HMA in July.

Defined IDMP phases:

  • Transition phase I      –    Product & Substance Pre-Submission – 1 July 2016 to 1Q 2017
  • Transition phase II    –    Product & Substance Submission – 1Q 2017 to 4Q 2017
  • Maintenance phase    –    Beyond 4Q 2017

IDMP Knowledge Database

  • KNect365 Webinar on IDMP Latest Updates and Timelines

“• The IDMP Standards and Guidelines

• IDMP in Europe: Roadmap and current timeline

• From where to obtain the IDMP data –internally and externally – and who needs to be involved

• What should be the next steps

• Conclusions”  …get the slides

  • The time to get ready for ISO IDMP is now

“Pharmaceutical companies will soon be required to submit data in accordance to the ISO IDMP standard in the EU region. The goal for the five ISO standards (11238, 11239, 11240, 11615 and 11616) is to standardize the identification of medicinal products. The FDA is expected to follow suit fairly quickly after EMA.

Implications for the pharmaceutical industry
The new standards will impact the preparation and planning of submissions and maintenance of data that is company-wide: from manufacturing data, and structured substance information to registration information. NNIT’s approach consists of five phases to help you become compliant…”  …read more

  • How A Pilot Program Can Help Answer the Questions of Data Sources and Costs to Compliance

Summary at a glance: To prepare for the coming IDMP requirements, a pilot program using a product sampling will tell you much about how you need to proceed with your full IDMP compliance plan for international requirements.” Read more…

  • Gap Analysis or Vision and Strategy: IDMP Approach Depends on Size and Needs

While the timing for Identification of Medicinal Products remains elusive, I’m heartened by the growing level of commitment that even mid-size pharma companies are showing to initiating IDMP projects.

Primarily there are two approaches that companies are taking: one is via a vision and strategy activity and the other is via a gap analysis. Both approaches are effective; choosing which makes most sense to you just depends on the size of your portfolio and project scope and how much up-front thinking you want to do. Read More…

About IRISS: “IRISS received 501 c-6 designation from Internal Revenue Service (IRS) on March 7, 2012. The 501 c-6 designation recognizes IRISS Forum as a pharmaceutical industry trade organization, which provides a mechanism for IRISS to collaborate with other trade organizations within the pharmaceutical industry (ie Pharma, DIA, RAPS, HL7) as well as global Health Authorities. IRISS represents a neutral forum for industry, vendors, health authorities, consultants, etc. to share information and work towards a standard method of implementing electronic submission specifications and improving interoperability of e-publishing tools, viewing tools, and systems.” Read more…

  • Converge or Be Purged: IDMP Product Standardization Deadline Looms – by John Lawrie

“The European Medicines Agency (EMA) has mandated that all life sciences organizations in Europe and those selling products in Europe demonstrate compliance with the Identification of Medicinal Products (IDMP) standards by July 1, 2016 and has created a task force to regulate the standards.

It’s now imperative for IT and business groups to begin formulating a strategy to not just comply with IDMP, but to embrace it as an impetus for change within the organization.

The Identification of Medicinal Products (IDMP) is a set of standards defined by the International Organization for Standardization (ISO). The initiative has enjoyed cross-border support, with the regulatory authorities of U.S., Canada, and Switzerland all publically committing to adoption at some point in the future while Japan, Australia, Russia, and Iran all expressing at least some level of interest. Europe is the first major region to officially adopt IDMP.” Read More…

Joel Finkle, Senior Strategist Regulatory Informatics, CSC Life Sciences

  • IDMP: Implementation Details Mixed Progress

“On February 19, 2016 I attended the EU IDMP Task Force meeting, which happens about three times per year, where the various subgroups of the task force reveal what they’ve been working on. I’m part of the Referentials group which is mainly working on the processes and programming interfaces for updating controlled vocabularies. That’s a critical path task for IDMP implementation as you can’t fill in the data fields until it’s known how to code them.

At the meeting, the Substance and Product group (which has the biggest scope) revealed an update to the expected requirements for the first iteration of IDMP in Europe.” Read more…

The building blocks of IDMP implementation (PDF-File)

“The potential benefits of meeting evolving Identification of Medicinal Product (IDMP) requirements extend far beyond regulatory compliance. Through IDMP implementation, pharmaceutical companies can unlock the power of product data to transform their business and improve patient health.

Implementation challenges
Many biopharma companies struggle with collecting and maintaining product information because it is typically siloed, unstructured and manually intensive to
update. IDMP compliance adds to the challenge, as companies are finding that a majority of required IDMP data does not reside in their information technology systems; rather, the data exists as text within product submission documents.” Read more…
Oracle IDMP Information

  • “IDMP is the hot topic in Pharma – The Oracle Solution helps Pharma companies to be prepared!

The Ambition of IDMP is Ultimate Patient Safety. IDMP stands for IDentification ofMedicinal 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.” Read More…

Accenture Life Sciences Blog

“In Europe, the 2016 deadline for complying with the IDMP standard is fast approaching. Are pharma companies ready?

The Identification of Medicinal Products (IDMP) standard is a highly detailed, cross-functional ontology designed to harmonize the collection, formatting and transmission of medicinal product information to regulatory authorities. The initiative has enjoyed cross-border support, with the regulatory authorities of US, Canada and Switzerland all publically committing to adoption at some point in the future and Japan, Australia, Russia and Iran all expressing at least some level of interest.The European Medicines Agency (EMA) has already mandated compliance by July 1, 2016.” Read More…

  • Aris Global – IDMP Medicinal Product: How complex could it get? (PDF)

“Regulatory authorities and the life sciences industry engage in an intensive information exchange during every phase – such as molecule development, drug evaluation and approval phase and the post-authorization phase – of the drug development lifecycle. The standardization of medicinal product information as envisioned in the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standards is regarded as the key towards a global and unified means of defining and sharing information.” Read More…

  • IDMP1 – IDMP Overview

“The IDMP Standards are a set of 5 ISO international standards that has been developed in response to a worldwide demand for internationally harmonised specifications for identification and description of medicinal products. IDMP provides the basis for the unique identification of medicinal products, which facilitates the activities of medicines regulatory agencies worldwide by jurisdiction for a variety of regulatory activities (development, registration and life cycle management of medicinal products, pharmacovigilance, and risk management). They can also be applied to Investigational Medicinal Products (IMP).

In IDMP Standards messaging specifications are included as an integral part. They describe and protect the integrity of the interactions for the submission of regulated medicinal product information in the context of the unique product identification; they include acknowledgement of receipt including the validation of transmitted information. Health Level Seven (HL7) Message Exchange are normative within the IDMP Standards.” Read More…

  • Identification of medicinal products

“Identification of Medicinal Products (IDMP) is a set of five ISO norms which has been developed in response to a world-wide demand for internationally harmonized specifications for medicinal products. IDMP provides the basis for the unique identification of medicinal products, it facilitates the activities of medicines regulatory agencies world-wide by jurisdiction for a variety of regulatory activities (development, registration and life cycle management of medicinal products; pharmacovigilance and risk management).” Read More…