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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

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®)

IDMP Wiki

SPOR

SPOR

(as of 23.03.2018, Ursula Tschorn, IDMP SPOR Industry Change Liaison)

SPOR is short for Substances Products Organisations and Referentials in the IDMP projects of the EMA. SPOR data services will act as the vehicle for implementation of ISO IDMP standards in the regulatory and the e-health world.

SPOR data services

SPOR is aimed at delivering quality data services on Substances, Products, Organisations and Referentials to power EU regulatory activities.

Four projects have been established

Four projects have been established at the EMA to implement services that centralise management of each of the domains of master data. The four projects are collectively known as SPOR data services and the single once are abbreviated with SMS, PMS, OMS and RMS.

SPOR Data Services

SPOR Data Services

Implementation of the four projects

The implementation of the four projects will be phased.

  • All proposals relating to implementation of the projects on Substances, Products, Organisation and Referentials have been and will continue to be consulted on widely with regulators and industry representatives.
  • IDMP with its referentials applies to both domains, Human and Veterinary
  • In parallel, EMA is implementing the messaging standards developed by Health Level Seven (HL7), which define a format for the electronic exchange of data that is compliant with the ISO IDMP technical specifications.

Use of SPOR in regulatory activities

Adoption of IDMP operating models will facilitate the implementation of consistent, centrally-maintained, ISO IDMP-compliant data, which will feed regulatory activity across the product lifecycle.

Benefits

Standardised data alone is not sufficient to achieve benefits. The benefits will be realised incrementally:

  • As all phases of SPOR are completed; and
  • Provided other opportunities for integration are implemented via EU Telematics Programmes such as CESSP, Clinical Trials EU Portal

New ways of accessing SPOR data

There are 4 ways of accessing the SPOR data:

  • web interface
  • APIs* (Application Programming Interface)
  • Draft API specifications have been shared with SPOR Task Force; final API specifications are expected to be published in August
  • For RMS, backward compatibility will be maintained with EUTCT for NCAs who use EUTCT
*An API is a mechanism to allow your IT systems to exchange information automatically with RMS and OMS

Download SPOR API Documentation
(Udated 9.1.2018)

A new edition (version 1.14 published 09.01.2018) of the SPOR API documentation (API schemas, OMS & RMS message formats and HL7) is accessible for interested parties for a free download in this website:

The latest version of the API specification incorporates the following additional information:

  • A description of how an implementing system must retain rowid elements in the creation, and later management, of change requests in RMS.
  • A description on the fields that have to be conditionally provided when dealing with both OMS and RMS change requests depending on the status and the data of such requests.
  • An explanation on how OMS retains compatibility for searching elements based on identifiers, even after they have been merged, and how the current identifier, of an element, is highlighted in the response data.
  • A description on what kind of change requests can be filed in OMS depending on the status of the referred organisation and/or location.
The API specification covers both RMS and OMS. This has been taken through consultation during April to July 2016 and the feedback has been incorporated in the specification (consultation is now closed).
wiki spor documentation

Please note that in the SPOR API specification, the services are set out in Section 6 and those that are OMS-specific are marked “O”, RMS-specific are marked “R”, and services shared by both RMS and OMS are marked as  “RO”.

The documents have been shared with the SPOR Task Force and UAT testers.

EMA Data Stewards

EMA will take over the function of a data steward to maintain and coordinate the SPOR data.

  • A specialised team of EMA staff that will manage data on behalf of stakeholders and provide user support
  • Validate access requests to SPOR services
  • Directly involved in maintaining the quality of the data:
    Profiling the data (assessing quality of data)
    Various data anomalies (different formats of the data e.g. telephone number) can be identified / monitored and data correction can be initiated
    Reports generated using this cleansed data will be more reliable
  • Take action on change requests for new/amended Referential Lists/Terms and Organisation data

Data content

RMS lists at go-live:

  • Lists from EUTCT (apart from Substance list)
  • Lists to support OMS
  • Lists for ISO 11239 (Pharmaceutical dose forms, units of presentation, routes of administration and packaging) and ISO 11240 (Units of measurement)
  • Some lists to support  PMS project (e.g. Material)

Content of the OMS dictionary at go live:

  • MAHs: (H+V) CAPs & (H) NAPs
  • MAAs: (H+V) CAPs
  • MRL applicants (Vet)
  • MA & MRL contacts: (H+V) CAPs

 

Referentials Management Services RMS Operating Model

wiki spor rms process in regulatory context

 

 

Organisations Management Services OMS Operating Model

SPOR Organisation Operating Model

 

Key Industry engagement activities

  • Industry is now asked to start with mapping activities from their local data to IDMP SPOR referentials
  • Industry Change Liaisons will provide a continuous channel for information and training throughout the year
  • In addition, a number of specific events are planned that will be open to all Industry stakeholders

In summary

  • SPOR data services will act as the vehicle for implementation of ISO IDMP standards
  • SPOR data services will enable the realisation of benefits at all stages of the product lifecycle due to future integration of regulatory processes with SPOR’s standardised data and central data management services
  • Implementation of RMS and OMS is the first step in a phased approach to roll-out of SPOR and of other Programmes dependent on SPOR data
  • In order to be ready for the future changes brought about by IDMP and by integration with other Programmes, Industry should prepare now to ensure they have the foundations in place through alignment with RMS and OMS

Webinar Implementing ISO IDMP: introduction to SPOR data services

Link to EMA´s Information on Substances, Products, Organisations and Referentials