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News From the EMA: IDMP Update

By  Brooke Casselberry Brooke Casselberry  on 2015-10-02 14:06:00  |  Featured in  Life Sciences , Regulatory Update
Brooke Casselberry
Posted By Brooke Casselberry
in Life Sciences in Regulatory Update
on 2015-10-02 14:06:00

brooke.casselberry.regulatoryIDMP is the Identification of Medicinal Products, an International Standards Organization (ISO) standards initiative to provide identification to drug products and enhance patient safety through Individual Case Safety Reports (ICSR).   This standard is being adopted globally by health authority agencies and organizations such as the World Health Organization.  IDMP allocates unique ID’s to each data point defined in the dictionaries and submitted to the health authorities.  These unique ID’s are then used to track products against safety for quicker action.

There are 5 standards in IDMP:

  1. Substances – ISO 11238
    1. Substances can have multiple roles (e.g. active, excipient), requiring an IDMP mapping for each substance and for each role of that substance
    2. Substances may have multiple components (e.g. intermediate versus secondary)
  2. Pharmaceutical Dose Forms, Units of Presentation, Routes of Administration, and Packaging – ISO 11239
    1.  Packaging may include intermediate packaging, outer packaging, kit packaging
  3. Units of Measurement – ISO 11240
    1. Rules for units of measurement and traceability to measurement standards and mapping requirements for different unit vocabularies and languages. 
  4. Regulated Medicinal Product Information – ISO 11615
    1. Medicinal product lifecycle characteristics including development, authorization, post-marketing status and renewal
  5. Regulated Pharmaceutical Product Information. – ISO 11616
    1. The Pharmaceutical Product ID (PhPID) representation of a medicinal product based on: Substances, Strengths, Strength Unit, Reference Strength, Dose Form.

The IDMP data model breaks down these 5 standards into their respective 7 functions of product detail and registration with varying degrees of interconnection.

IDMP_Graphic

The European Commission and EMA are requiring compliance with IDMP in a phased approach as of July 1st 2016.  The phases for implementation are as follows, the data points/fields required in each phase has not been made official and are subject to change between now and July 1st:

  • Preparation Phase – This is now and the work that should be occurring currently to be prepared for compliance as of July 1, 2016
  • Transition Phase
    • Product Substance and Substance Pre-Submission July 1, 2016 – Q1 2017
    • Product and Substance Submission Q1 2017 – Q4 2017
  •          Maintenance Phase
    • Beyond Q4 2017

One baseline, single active ingredient, single indication product can have more than 250  data points alone defined in the IDMP data standards.  The challenge then remains, is the data readily available, is it consistent, and how are the IDMP nomenclature standards going to be applied?  The likely hood of having all of the required information in one system is very low.  Even a robust Regulatory Information Management system does not contain all of the data points.  In most cases this information will be captured in excel files, regulatory archive solutions, clinical databases, manufacturing locations.  The next challenge is how the information will get from the current locations to the agencies.  There are a few vendors on the market working to develop their IDMP compliance tools to facilitate this action.

Paragon Solutions has expertise crossing all areas of product development and post marketing activities: Regulatory, Clinical, Supply Chain and Manufacturing, Labeling, and Information Management.  As a non-software client services organization, Paragon operates with complete non-bias in process development, system implementations, and vendor selection processes.  During IDMP evaluations, we provide services as necessary for the organizations in which we are working.  IDMP services include:

  • Gap Analysis – Identification of IDMP content across the organization, systems which house the content, and evaluation of steps necessary for compliance.
  • Standardization – Co-development and application of standards to existing data, data cleansing, and interoperability evaluation/testing
  • Strategy – IDMP implementation strategy and approach including Regulatory Information Management (RIM) and Master Data Management (MDM).
  • Process Development – Cross Functional operations
  • Vendor Evaluations – RFI and RFP development and review for IDMP/RIM vendors
  • Software Implementations, Validation, and Migration
  • Training – Regulatory Standards training for individuals or teams

For more information on Paragon's services,  request a free consultation.

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Brooke Casselberry

Brooke Casselberry

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Brooke Casselberry, MSRA, RAC, is Paragon's Associate Director of Regulatory Services and subject matter expert. With more than 15 years of experience in regulatory affairs and operations, Brooke has led projects and initiatives involving more than 50 biopharmaceutical companies globally, contributing submissions, intelligence, management expertise and thought leadership.

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