IDMP Wiki

EU IDMP Task Force

The EMA and the EU Regulatory Network have founded an EU IDMP Task Force with the involvement of terminology organisations, software vendors and developers of medicinal products dictionaries or databases. The task force will be responsible for advising on the planning, development, implementation and maintenance of the ISO IDMP standards in the EU, in line with requirements defined at international level and based on agreed EU implementation principles.

More details on the EU IDMP Task Force are to find here.

IDMP Wiki

GINAS

Global Ingredients Archiving System (GINAS)

What is GINAS in relation to ISO 11238

GINAS and ISO 11238 specifically addresses the identification and exchange of regulated information on substances.  GINAS supports all substance types described in the 11238 standard and provide multiple language capability for the naming of substances and controlled terminology used within the IDMP.

Background of GINAS

Globalization presents tremendous challenges and opportunities for national regulatory agencies, the pharmaceutical industry, and global health as a whole. Emerging diseases and the health impacts of catastrophic events respect no national boundaries, nor does the increasing volume of substandard, contaminated, and counterfeit products that overburdens national regulators. Ingredients for pharmaceutical products are typically sourced on a global basis and it is very rare that all ingredients for a single product are produced within one jurisdiction. To regulate the global supply chain efficiently and to better respond to and prepare for catastrophic events it is essential to have a global information system for pharmaceutical ingredients.

ISO 11238 specifically addresses the identification and exchange of regulated information on substances. Working closely with that standard’s authors and regulatory authorities from various countries, NCATS is developing an information system to register and store substance-related information and provide identifiers. This will ensure a robust substance registration system that supports the additional needs of national and regional authorities and is consistent with the ISO 11238 standard. The system will support all substance types described in the 11238 standard and provide multiple language capability for the naming of substances and controlled terminology used within the system.

GINAS Project Description

The Global Ingredient Archival System (GINAS) represents a major opportunity for regulators worldwide to tackle the challenges of sharing ingredient information. This tool will make it possible to create a global standard for defining substances and a common identifier to identify ingredients in medicinal products. This will enable the global health community to share and use information to significantly improve health care delivery, the proper use of medications, and the management of risks involved in their use.

The project’s main goal is to provide a consistent definition of substances globally, and a common identifier for all the substances used in marketed medicinal products as well as active substances under clinical investigation. It is envisioned that a consortium of regulators from different national and international agencies would operate and maintain the platform in a secure and trusted manner. This centralized database will result in higher quality data while still respecting confidentiality requirements.

The software tools used in this project will be developed, maintained, and distributed to project members and other interested parties by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH). As well as containing definitional information and identifiers, the system will be able to store a wide variety of structured information on the identification, analysis, use, manufacture, pharmacology, and toxicology of medical product substances.

Goal of the Program

GINAS is a solution to the costly, duplicative, and piecemeal approaches currently being used. It will enable regulators to more easily monitor the global marketplace. The system could play a vital role in facilitating a global approach to pharmacovigilance; identifying and tracking substandard products and ingredients; alleviating drug shortages; enhancing clinical development; and coordinating and streamlining regulatory actions worldwide. The project will benefit industry by offering a “one-stop shop” to deposit substance-related regulatory information. It will help in developing specifications of substances and products in a more consistent manner, and in coordinating facility inspections. Finally, the project should dramatically reduce the time and costs of information-gathering for both companies and regulators.
NCATS intends this software product to be a freely distributable, maximally self-contained system to register substances and related manufacturing, analytical, and relevant biological information on substances that are of interest to health product regulators, product sponsors, and health researchers. Consistency will be achieved through a common data model and synchronization with a central database.
GINAS will be able to store, retrieve, and distribute substance-related information described in the ISO 11238 standard. It will enable authorized agents to register new substances and curate and review existing substance data. Currently under development, the NCATS system is anticipated to have its first full release in June 2014.
Since February 2013, Canadian, Dutch, German, Swiss, and U.S. regulators have been working with NCATS to create this system. Health Canada is providing an environment for collaborative development. In the future, this environment could support the initial curation and mapping of content used for global substance identification.
The project group welcomes participation and sponsorship by regulatory agencies and other public health organizations throughout the world. It aims to be a global resource that will benefit public health by facilitating the transfer of regulatory information and providing industry and other interested stakeholders with a uniform process for depositing substance-related information.

IDMP Wiki

IDMP

IDMP Definition of Identification of Medicinal Products

IDMP defines the data elements and structures for the unique identification and exchange of medicinal products´ information.

Download here for free the “What is IDMP” PDF File

Iso IDMP Standards at a glance

IDMP Standards - What is IDMP?

ISO IDMP Standards

The set of fife ISO international standards has been developed by the ISO in response to a worldwide demand for internationally harmonised specifications for identification and description of medicinal products.

Article 40 of the new pharmacovigilance implementing measures legislation mandated the EMA to use the ISO IDMP standard latest by July 2016.

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.

Messaging specifications are included as an integral part of the IDMP Standards. 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.

IDMP Standards are completed with Implementation Guides which are currently in development (2015), as well as with Technical Specifications (TS) 16791 (provides guidance for the identification of medicinal products by using intenational supply chain Standards, securing traceability, safe supply chain and other market requirements) and Technical Requirements (TR) 14872 (Requirements for the implementation of the Standards for the identification of medicinal products for the exchange of regulated medicinal product Information), the latter being in development.

Implications for Marketing Authorisation Holders (MAHs)

In order to submit the data all branches of a company should share a common language, from pharmacovigilance to product supply to comply with the controlled vocabulary dedicated.
The structured substance information, and controlled vocabularies for pharmaceutical dose forms, units of presentation, routes of administration, and packaging will be challenging to integrate.
Furthermore the terminology needs to be aligned throughout the company.

You will find more details here

IDMP Wiki

IDMP Stakeholder Mindmap

IDMP is aimed to be used wide out of the regulatory silo. Actually it will close the circle between the regulatory and the e-health world. This is the tremendous value of IDMP for the health care market worldwide. IDMP is the base for identifying medicinal products uniquely across all stakeholders.

IDMP Stakeholder Mindmap

IDMP was first aimed to support Pharmacovigilance (PV) reporting for ICSR, PSUR, and PV Databases. However IDMP will affect many more areas, processes and stakeholders in the health care market:

  • the identifying of products not near Medicinal Products (MP), cosmetics, dietery supplements, vet products, and medical devices
  • the identifying of aministrable product, pharmaceutical product, authorised products and Investigational Medicinal Products (IMP)
  • the communication in Clinical Trials (CT) and Clinical Trials Application (CTA) –  e.g. CT-Sponsor to the Contract Research Organisation (CRO),  and regulator to World Wide (WW) Databases, patients to regulator concerning Adverse Drug Reactions (ADR) and many more
  • the labeling (e.g. SPL and SmPC)
  • the messaging (e.g. XEVMPD, HL7, SPL, ICSR, eCTD)
  • the patient record and even the medication plan

This IDMP Stakeholder Mindmap has been prepared by Andreas Franken (Bundesverband der Arzneimittel-Hersteller e.V. BAH, Germany)

wiki_idmp-stakeholder-mindmap

 

 

 

IDMP Wiki

ISO 11238

Regulated information on substances (ISO 11238)
ISO 11238 defines substances by their main, general characteristics and Specified Substances (which are more granular, specific descriptions of a substance, e.g. including manufaturing information, purity, grade). Substances can have different roles in medicinal products (e.g. active, adjuvant). They are identified via their molecular weight, structure and their unique Identification Number (ID).

Synonym and Abbreviations for Amlodipin (as example):
(RS)-2-[(2-Aminoethoxy)methyl]-4-(2-chlorphenyl)-6-methyl-1,4-dihydropyridin-3,5-dicarbonsäure-3-ethylester-5-methylester (IUPAC)
3-Ethyl 5-methyl (+/-)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate (WHO)
AMLODIPIINI
Amlodipin (ABDATA-SK)
Amlodipin (ABDATA-SK;ASK;INN.L25.D)
AMLODIPINA
AMLODIPINĂ
AMLODIPINAS
Amlodipine (BAN1999;DCF;INN.L25.E;INN.L25.F)
Amlodipino (INN.L25.S)
AMLODIPĪNS
Amlodipinum (INN.L25.L)
AMLODYPINA
ΑΜΛΟΔΙΠΊΝΗ
ΑΜΛΟΔΙΠΊΝΗΣ
АМЛОДИПИН

Synonym Details:

Term Lang Role Code Type Source
(RS)-2-[(2-Aminoethoxy)methyl]-4-(2-chlorphenyl)-6-methyl-1,4-dihydropyridin-3,5-dicarbonsäure-3-ethylester-5-methylester N/A SY 1134301 SUB ABDATA
3-Ethyl 5-methyl (+/-)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate N/A SY 1134301 SUB ABDATA
AMLODIPIINI FI ST SUB05467MIG SUB EMA
Amlodipin DE ST C08CA01 ATC WHO
Amlodipin N/A PT 1134301 SUB ABDATA
Amlodipin DA ST SUB05467MIG SUB EMA
Amlodipin HR ST SUB05467MIG SUB EMA
Amlodipin HU ST SUB05467MIG SUB EMA
Amlodipin SK ST SUB05467MIG SUB EMA
Amlodipin SL ST SUB05467MIG SUB EMA
AMLODIPINA ES ST SUB05467MIG SUB EMA
AMLODIPINA IT ST SUB05467MIG SUB EMA
AMLODIPINĂ RO ST SUB05467MIG SUB EMA
AMLODIPINAS LT ST SUB05467MIG SUB EMA
Amlodipine N/A PT SUB05467MIG SUB EMA
Amlodipine FR ST SUB05467MIG SUB EMA
Amlodipine N/A SY 1134301 SUB ABDATA
Amlodipine EN PT 1J444QC288 SUB FDA
Amlodipine EN PT C08CA01 ATC WHO
Amlodipino N/A SY 1134301 SUB ABDATA
Amlodipino ES ST SUB05467MIG SUB EMA
AMLODIPĪNS LV ST SUB05467MIG SUB EMA
Amlodipinum CS ST SUB05467MIG SUB EMA
Amlodipinum LA ST SUB05467MIG SUB EMA
Amlodipinum N/A SY 1134301 SUB ABDATA
AMLODYPINA PL ST SUB05467MIG SUB EMA
ΑΜΛΟΔΙΠΊΝΗ EL ST SUB05467MIG SUB EMA
ΑΜΛΟΔΙΠΊΝΗΣ EL ST SUB05467MIG SUB EMA
АМЛОДИПИН BG ST SUB05467MIG SUB EMA

Other Properties:

Type Code Descr
ATC C08CA01 Calcium channel blockers
Selective calcium channel blockers with mainly vascular effects
Dihydropyridine derivatives
Amlodipine
Contributing Source ABDATA WHO FDA FDB EMA
Semantic Type SUB ATC
CAS-Registry Number 88150-42-9
Molecular formula C20H25ClN2O5
Molecular weight 408,88

Synonym and Abbreviations:
Amlodipin benzolsulfonat (1:1)
Amlodipine besilate (BAN1999;BP)
Amlodipine besylate (USAN;USP)
Amlodipini besilas

Weblinks:
Visit the IDMP Term Browser® with ISO 11238 data on Amlodipine Besilate in idmp1 (access restricted to registered users of the IDMP Term Browser®)