ISO IDMP

ISO IDMP

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IDMP – Identification of Medicinal Products

The implementation of IDMP is arguably the most significant development in drug safety, since the inception of systematic safety reporting back in the 1960’s.

All Marketing Authorisation Holders (MAH’s) should now be familiar with IDMP; however for many, it remains something of a conundrum. PDS is here to help you.

Our professional TEAM has extensive experience in Pharmacovigilance, Regulatory Affairs and vital knowledge and experience gained from thousands of successful xEVMPD submissions (most closely related to IDMP), meaning we will provide you with all the support you need to achieve IDMP compliance.

Working Together

PDS works with you to create a bespoke solution through listening and understanding, to identify where your real issues are. We then address those issues and help you to optimise your workload and create realistic timelines in preparing your business to be ready for IDMP, whilst always ensuring you work to standard implementation guides.

Our experts will help you create a flexible strategy, which begins by establishing your main areas of concern and then identifying key areas of focus and benefit moving forward.

TEAM

Using our proven TEAM methodology (Thorough, Effective, Accurate, Manageable) we will help to ensure your company adheres to the IDMP guidelines.

Thorough auditing of your data and processes ensures Effective identification and Accuracy of your IDMP data followed by the development of Manageable processes to ensure a smooth transition to IDMP compliance.

Our Key Services include:

  • IDMP gap-fit analysis
  • Data format alignment and identification of missing data
  • Establishing process coverage of IDMP data
  • Data entry/data conversion
  • Submission piloting and testing
  • Planning, implementation, execution and reporting of (interim) XEVMPD maintenance

Contact us today to find out how PDS can help you.

What is IDMP and what does it mean for MAH’s?

IDMP is a legal requirement and non-compliance can carry financial penalties of up to 5% of annual revenues.

It is a (European led) global initiative jointly agreed between the member regional health authorities of the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) to produce a single framework for uniquely identifying and exchanging data on medicinal products referenced in Individual Case Safety Reports (ICSR’s) worldwide.

Improved patient safety is its core and it will, ultimately, replace the EU’s xEVPMD (Extended Eudravigilance Medicinal Product Dictionary) and the FDA’s SPL (Structured Product Labelling) systems with five standards defined by the International Organisation for Standardisation (ISO).

IDMP Framework

IDMP is imperative in enabling the unique identification of medicinal products reported in Individual Case Safety Reports (ICSR’s) worldwide. All of the ICH regional health authorities are working collaboratively to ensure there are no pitfalls, flaws or gaps in the IDMP framework.

Implementation of the IDMP standards and the design and development of a workable technical framework is proving to be highly complex, leading to inevitable delays in confirming the implementation deadlines for IDMP. Whilst this is frustrating for both regulators and industry, ‘getting it right’ is absolutely paramount in order to deliver a robust and harmonised system. This is particularly relevant when considering the history of ‘false starts’ that have occurred in the EU, so it makes sense that IDMP should be handled with care.

There are many stakeholders involved in the implementation process, which includes the ICH Regional Health Authorities, National Competent Authorities (NCA’s), industry (MAH’s), and vendors of IDMP software.

Who are the likely internal stakeholders?

hexagon-graphicIDMP’s impact is significantly wider reaching within the MAH’s organisation than the incumbent xEVMPD.

It will impact numerous business units beyond Pharmacoviliance and may include Regulatory Affairs, Clinical, R&D, Manufacturing, Packaging and Labelling, Quality, Legal and IT.

Key stakeholders may include Drug Safety Senior personnel, Regulatory Senior personnel, XEVMPD Managers, Project Managers, IT Managers and professionals involved in master data management (MDM). Board level Directors should also be fully engaged and supportive of IDMP.

Data requirements will be significantly more ‘comprehensive’ and ‘granular’ than current xEVMPD requirements (with potentially hundreds of additional data fields).

It will also need to be fully compatible with the Healthcare Level Seven (HL7) messaging standards, which potentially means investment in new supporting IT systems for MAHs.

IDMP’s implementation in the EU plans to use an iterative approach, which was originally scheduled to commence on 1 July 2016. However, all of the Implementation Guides (IG) and Standards are still under review, with the majority being prepared for publication at the (earliest) end of Q1 2017.

Where are we now?

There seems to be consensus within industry that the slow progression towards finalising IDMP guidance and timelines means that little can be done by MAHs in the interim.

It is important to use this time to understand the impact IDMP will have on you and moreover, ensure a solution is found that fits with your situation.

PDS takes a hands on approach in addressing your concerns and the broader perspectives of IDMP. Meanwhile ensuring you can take the opportunity to set up the necessary processes in your organization that give you tangible benefits, next to achieving timely IDMP compliance.

Examples of what MAHs can be looking at:

  • Data – where is it, who owns it, is it accurate, what format is in?
  • Creating a best practice approach to data management
  • Ensuring all key stakeholders sufficiently involved in the IDMP planning process
  • What small steps can you make to prepare your environment for practical IDMP compliance?
  • Vendor participation and readiness.

PDS is committed to IDMP for the long term, just as we have been committed to xEVMPD since its announcement by the EMA in 2011.

We aim to continue with our proactive philosophy by partnering with MAHs to alleviate their concerns about what is coming, and help them to prepare for the inevitable, by focusing on creating an actionable plan for the future to achieve IDMP compliance.

IDMP Workshop

PDS and Iperion will be running an IDMP workshop in 2017.

The workshop provides you with an opportunity to discuss your key questions and concerns about IDMP, directly with our experts. It is entirely focused on talking with you, as opposed to talking at you, to ensure you leave the event with a much clearer idea of how to work through the next stage of your IDMP plans.

By attending our workshop PDS and Iperion can:

  • Optimise your workload
  • Create timelines for you
  • Address your real issues
  • Create your bespoke solution

The target audience for this workshop is: Drug Safety Senior personnel, Regulatory Senior personnel, XEVMPD Managers, ISO IDMP Managers, IT and people involved in master data management.

Delegate places will be limited, so please visit our events page for further details or register to receive our regular updates. In the interim, please share your views and concerns about complying with the IDMP regulations by taking our short online survey. Click here to take part

Contact us today to find out how PDS can help you.

Glossary of Terms

EVMPD : EudraVigilance Medicinal Product Dictionary. EuduraVigilance is the European Medical Agency’s own form of pharmacovigilance system.

XEVMPD : Extended EudraVigilance Medicinal Product Dictionary. Since July 2012, every marketing authorisation holder (MAH) has been required to submit product data about all authorised medicinal products for human use to the XEVMPD. This became mandatory on 2nd July 2012. There are no exceptions.

EVWeb : EudraVigilance Tool

EMA : EuduraVigilance European Medicines Agency

IDMP : Identification of Medicinal Products

ICSR : Individual Case Safety Reports

HL7 : Health Level 7

SDO : Standards Development Organisation

ISO : International Organisation for Standards

CEN : European Committee for Standardisation

CDISC : Clinical Data Interchange Standards Consortium

IHTSDO : International Health Terminology SDO

The IDMP standards

ISO 11615:2012

Medicinal Products Information (MPID)

ISO 11616:2012

Pharmaceutical Product Information (PhPID)

ISO 11238:2012

Substance Information

ISO 11239:2012

Pharmaceutical Dose Forms
Units of Presentation
Routes of Administration
Packaging

ISO 11240:2012

Units of Measurement (UOM)

Find out more about ISO IDMP

read our blog

Have a question? Just call +44 (0) 1476 512395 or email info@puredrugsafety.com